A Study Evaluating the Efficacy and Safety of ST-0529 in Subjects With Moderately to Severely Active Ulcerative Colitis

Study Purpose

Study CYC-202 is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of ST-0529 in subjects with moderately to severely active UC, defined as a score of 5 to 9 on the 3-Component Adapted Mayo Score (comprised of rectal bleeding, stool frequency and endoscopy sub-scores; score range 0-9).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Male and female adult subjects 18 to 75 years old, inclusive. 2. Willing to provide written informed consent and to be compliant with the schedule of study visits and protocol assessments. 3. Diagnosis of UC established at least 3 months prior to the Baseline visit, by clinical and endoscopic evidence (colonoscopy or flexible sigmoidoscopy) 4. Moderately to severely active UC defined as the 3-Component Adapted Mayo Score of 5-9, inclusive, with an endoscopic sub-score of ≥ 2 (from central reading), and a rectal bleeding sub-score of ≥ 1, as determined 10 days (± 3 days) prior to Baseline. 5. Evidence of active UC, confirmed histologically (from local read), extending proximal to the rectum with ≥ 15 cm of involved colon. 6. At Screening, a colonoscopy will be required if the subject has had extensive colitis or pancolitis of > 8 years duration or left-sided colitis of > 12 years duration but has not had a colonoscopy within 1 year of the initial screening date. If the subject has had a colonoscopy within 1 year of the initial screening date, a flexible sigmoidoscopy may be used. 7. Subjects presenting at Screening with moderately to severely active UC demonstrating an inadequate response or loss of response or intolerance/medical contraindication to at least one of the following conventional therapies for UC: a. Corticosteroids: i. Signs and symptoms of active disease despite treatment with an adequate dose (e.g., prednisolone > 40 mg/day or equivalent) over a period of 4 weeks for oral therapy or intravenously (IV) for up to 1 week or ≥ 9 mg/day oral budesonide; OR ii. Unable to reduce corticosteroids below the equivalent of prednisolone 10 mg daily orally within 3 months of starting steroids or having experienced a relapse within 3 months of stopping steroids; OR iii. History of, or current intolerance to corticosteroids (including, but not limited to Cushing's syndrome, osteopenia/osteoporosis, hyperglycemia, insomnia, infection). b. Immunomodulators: i. Signs and symptoms of active disease despite at least 3 months of treatment with a sufficient dose (oral azathioprine ≥ 1.5 mg/kg or 6-mercaptopurine [6-MP] ≥ 0.75 mg/kg); OR ii. History of, or current dose-limiting toxicity associated with use of the agent (e.g., but not limited to nausea/vomiting, abdominal pain, pancreatitis, liver function test [LFT] abnormalities, lymphopenia, TPMT genetic mutation, infection). c. Anti-tumor necrosis factor (anti-TNF) agents: i. Signs and symptoms of active disease despite treatment with a single anti-TNF agent. Treatment failure is defined as a relapse after an initial response to therapy as follows:
  • - Infliximab: At least 4 infusions of at least 5 mg/kg within a 14-week timeframe for induction and maintenance; - Adalimumab: Induction regimen incorporating 160 mg at Week 0 (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days) and 80 mg at Week 2, followed by maintenance treatment of 40 mg every other week up to at least Week 8; - Golimumab: Induction regimen incorporating 200 mg subcutaneous (sc) injection at Week 0, followed by 100 mg at Week 2 and then maintenance treatment of 50 mg or 100 mg (weight dependent) every 4 weeks after completion of the induction regimen up to at least Week 12; OR ii.
History of, or current intolerance (with an initial response), defined as the presence of clinically significant side-effects, including infusion-related hypersensitivity. d. Vedolizumab: i. Signs and symptoms of active disease despite a history of at least one induction regimen, defined as at least a 14-week (10 weeks in the EU) induction consisting of 300 mg IV at Weeks 0, 2 and 6. OR ii. History of intolerance to vedolizumab including, but not limited to, serious infections, hepatotoxicity, heart failure, allergic reactions, or any other condition that contributed to discontinuation of the agent. 8. Subjects receiving oral corticosteroids for the treatment of UC must be on a stable dose of ≤ 40 mg/day (prednisolone or equivalent), or ≤ 9 mg/day budesonide. This dose must be stable from the initial Screening visit until 1 week after the initiation of study treatment. 9. Subjects receiving oral 5-ASA must be on a stable dose from the initial Screening visit until the end of the study. 10. Subjects willing to cease the use of any therapeutic enema or suppository or foams, other than that required in preparation for study-mandated colonoscopy/flexible sigmoidoscopies, from the initial Screening visit until the end of the study. 11. Subjects willing to cease use of azathioprine or 6-MP from the initial Screening visit until the end of the study. 12. Negative serum pregnancy test in females of childbearing potential at Screening. 13. If female and of childbearing potential, must agree to be sexually abstinent or use one of the following highly effective methods of birth control from the initial Screening visit until 30 days after the last dose of study drug is administered: 1. Hormonal contraceptives (e.g., combined oral contraceptives, patch, vaginal ring, injectables, and implants); 2. Intrauterine contraceptive system; 3. Surgical sterilization or partner sterile (must have documented proof); AND One of the following effective methods of birth control: 1. Male/female condom; 2. Cervical cap with spermicide; 3. Diaphragm with spermicide; 4. Contraceptive sponge. 14. Male subjects must be either surgically sterile (must have documented proof), agree to be sexually inactive or use a double-barrier method of birth control (e.g., condom and diaphragm with spermicide, condom with cervical cap and spermicide) from first study drug administration until 90 days after final drug administration.

Exclusion Criteria:

If a subject has any of the following criteria, they will be excluded from the study: 1. Subjects without previous treatment for UC. 2. Ulcerative colitis limited to rectum (ulcerative proctitis). 3. Evidence of acute severe colitis with toxic megacolon, abdominal abscess, bowel stricture or bowel perforation. 4. A diagnosis of Crohn's colitis, colitis yet to be classified, ischemic colitis, NSAID-induced colitis, idiopathic colitis (i.e., colitis not consistent with UC) or radiation colitis. 5. Subjects with evidence of pathogenic bowel infection (Clostridium difficile, Escherichia coli, Salmonella, Shigella or Campylobacter). 6. Previous surgery for UC or, in the opinion of the Investigator, will likely require surgery for UC during the study. 7. Any histological evidence of mucosal dysplasia. 8. Subjects with a current or recent history of severe, progressive or uncontrolled cardiac (including uncontrolled hypertension), renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurological (e.g., history of seizures) disease, abnormal magnesium or potassium levels, hypocholesterolemia, or any other severe co-morbidity that, in the opinion of the Investigator, could confound the study results or put the study subject at unreasonable risk. 9. Malignancies or history of malignancy within 5 years of the initial Screening visit, with the exception of adequately treated or excised non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin. 10. Any of the following laboratory abnormalities during the screening period
  • - if values are initially outside the prescribed limits, the evaluation may be repeated once within the screening period to determine eligibility: 1.
Hemoglobin level < 8.0 g/dL 2. Absolute WBC count < 3.0 × 10^9/L 3. Absolute Lymphocyte count < 0.5 × 10^9/L 4. Absolute neutrophil count < 1.2 × 10^9/L 5. Platelet count < 100 × 10^9/L or >1200 × 10^9/L 6. ALT or AST > 2.0 × ULN 7. Alkaline phosphatase > 2.0 × ULN 8. Serum creatinine > 1.5 × ULN 9. Bilirubin > 1.5 × ULN 11. Subjects with active TB infection or known history of prior treated or untreated TB infection. 12. Subject with a positive serology test result for HIV (HIV type 1 or type 2). 13. Subject with a positive serology test result for active HBV or HCV infection. 14. Treatment with biologic agents for UC within 56 days or 5 half-lives (whichever is greater) prior to the Baseline visit. 15. Treatment with any calcineurin inhibitor (e.g. cyclosporine or tacrolimus) within 28 days prior to the Baseline visit. 16. Treatment with methotrexate or JAK inhibitors (e.g. tofacitinib) from the initial Screening visit until the end of the study. 17. Initiation of treatment with an oral or IV corticosteroid from the initial Screening visit until the end of the study. 18. Use of any strong inhibitors of CYP enzymes (e.g., cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem, grapefruit juice and HIV antivirals) within 14 days prior to the Baseline visit. 19. Use of strong or moderate P-gp inhibitors (e.g., amiodarone, azithromycin, clarithromycin, itraconazole, ketoconazole, dronedarone, lapatinib, quinidine, ranolazine, verapamil) within 14 days prior to the Baseline visit. 20. Use of any herbal medication for the treatment of UC or which might interfere with CYP enzymes within 14 days prior to the Baseline visit. 21. Subjects vaccinated with a live or live-attenuated vaccine within 14 days of the Baseline visit, or planned vaccination during conduct of the study. 22. Subjects with a QTcF of > 450 ms for males and > 470 ms for females at Screening. 23. A history of risk factors for Torsades de pointes (e.g., history of heart failure, hypokalemia, family history of Long QT Syndrome). 24. Known hypersensitivity to cyclosporine or any excipients contained in ST-0529. 25. History of alcohol or drug abuse in the year prior to the initial Screening visit. 26. Subjects currently breast feeding, pregnant, or unwilling to delay initiation of breast feeding for at least 90 days after the last dose of study drug is administered. 27. Participation in another clinical trial and having received investigational medication within 30 days or within 5 half-lives (whichever is longer) prior to the Baseline visit, or concurrent participation in another clinical trial. 28. Subjects who, in the opinion of the Investigator, are unsuitable for inclusion in the study.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03844932
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Sublimity Therapeutics Holdco Limited
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Sponsor Responsible Medical Officer
Principal Investigator Affiliation Sublimity Therapeutics (HoldCo) Ltd
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

IndustryIndustry
Overall Status Recruiting
Countries Belarus, Bulgaria, Canada, France, Germany, Hungary, Ireland, Israel, Italy, Poland, Romania, Russian Federation, Serbia, Spain, Ukraine, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Colitis, Ulcerative
Additional Details

The study consists of a Screening period, Treatment period and Follow-up. The Screening period is comprised of two separate in-clinic visits, SV1 and SV2. At the initial Screening visit (SV1), subjects will be required to provide written informed consent to participate in the study and will then be assessed for eligibility. Electronic diaries will be provided to subjects at this visit to use for the duration of the study in order to record information relating to their UC disease. Subjects will return to the clinic for their Screening endoscopic assessment (SV2). Ulcerative colitis disease activity for eligibility will be assessed using the 3-Component Adapted Mayo Score. Upon successful completion of the Screening period, subjects will return to the clinic for their Baseline visit. During the Treatment period, subjects will be evaluated in the clinic at Baseline (Day 1), Week 2, Week 4, Week 8, and Week 12 (End of Treatment Period). At Week 6 and Week 10, subjects will be contacted by telephone to assess Adverse Events (AEs), concomitant medication usage and study drug regimen adherence. Subjects who complete the 12-week Treatment period will attend the Week 16 End of Study (EOS) visit. Subjects who discontinue study drug and withdraw or are withdrawn from the study before the Week 12 visit will be requested to return to the clinic as soon as possible to complete an Early Termination (ET) visit.

Arms & Interventions

Arms

Experimental: ST-0529 18.75 mg

ST-0529: 18.75 mg orally twice daily (BID)

Experimental: ST-0529 37.5 mg

ST-0529: 37.5 mg orally twice daily (BID)

Experimental: ST-0529 75 mg

ST-0529: 75 mg orally twice daily (BID)

Placebo Comparator: Matching Placebo

Placebo: matching placebo orally twice daily (BID)

Interventions

Drug: - ST-0529

ST-0529 utilizes SmPill® technology to encapsulate the otherwise insoluble cyclosporine in a presolubilized, lipid-based formulation.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Sharp Chula Vista eStudy Site, Chula Vista, California

Status

Recruiting

Address

Sharp Chula Vista eStudy Site

Chula Vista, California, 91911

Site Contact

Michael Waters, MD

info@sublimitytherapeutics.com

619-955-5246

Palmtree Clinical Research Inc, Palm Springs, California

Status

Recruiting

Address

Palmtree Clinical Research Inc

Palm Springs, California, 92262

Site Contact

Homan Abdollahzadeh, MD

info@sublimitytherapeutics.com

760-778-7799

Alliance Clinical Research, Poway, California

Status

Recruiting

Address

Alliance Clinical Research

Poway, California, 92064

Site Contact

Kevin Merkes, MD

info@sublimitytherapeutics.com

949-973-3704

Gastro Florida, Clearwater, Florida

Status

Recruiting

Address

Gastro Florida

Clearwater, Florida, 33756

Site Contact

Michael Weiss, MD

info@sublimitytherapeutics.com

727-336-7682

Advanced Research Institute, Largo, Florida

Status

Recruiting

Address

Advanced Research Institute

Largo, Florida, 33377

Site Contact

Jatin Bidani, MD

info@sublimitytherapeutics.com

713-559-7351

Advanced Research Institute, Inc., New Port Richey, Florida

Status

Recruiting

Address

Advanced Research Institute, Inc.

New Port Richey, Florida, 34653

Site Contact

Curtis Freedland, DO

info@sublimitytherapeutics.com

727-835-3261

Endoscopic Research Inc, Orlando, Florida

Status

Recruiting

Address

Endoscopic Research Inc

Orlando, Florida, 32803

Site Contact

Henry Levine, MD

info@sublimitytherapeutics.com

407-241-3229

Meridien Research, Spring Hill, Florida

Status

Withdrawn

Address

Meridien Research

Spring Hill, Florida, 34609

University of Chicago, Chicago, Illinois

Status

Recruiting

Address

University of Chicago

Chicago, Illinois, 60637

Site Contact

Atsushi Sakuraba, MD

info@sublimitytherapeutics.com

773-834-7414

Indianapolis, Indiana

Status

Recruiting

Address

IU Research, an Affiliate of Aerotek, Division of Gastroenterology/Hepatology

Indianapolis, Indiana, 46202

Site Contact

Sashidhar Sagi, MD

info@sublimitytherapeutics.com

713-559-7351

Houma Digestive Health Specialists, LLC, Houma, Louisiana

Status

Withdrawn

Address

Houma Digestive Health Specialists, LLC

Houma, Louisiana, 70360

Capitol Research, Rockville, Maryland

Status

Withdrawn

Address

Capitol Research

Rockville, Maryland, 20850

AGA Clinical Reasearch Associates, LLC, Egg Harbor Township, New Jersey

Status

Recruiting

Address

AGA Clinical Reasearch Associates, LLC

Egg Harbor Township, New Jersey, 08234

Site Contact

Barry Kaufman, MD

info@sublimitytherapeutics.com

713-559-7351

Charlotte, North Carolina

Status

Withdrawn

Address

Charlotte Gastroenterology & Hepatology, PLLC

Charlotte, North Carolina, 28207

Consultants for Clinical Research, Cincinnati, Ohio

Status

Withdrawn

Address

Consultants for Clinical Research

Cincinnati, Ohio, 45219

Vanderbilt University Medical Center, Nashville, Tennessee

Status

Withdrawn

Address

Vanderbilt University Medical Center

Nashville, Tennessee, 37212-1375

Spring Gastroenterology Associates, Houston, Texas

Status

Recruiting

Address

Spring Gastroenterology Associates

Houston, Texas, 77002

Site Contact

Ravi Moparty, MD

info@sublimitytherapeutics.com

281-888-5564

Baylor College of Medicine, Houston, Texas

Status

Recruiting

Address

Baylor College of Medicine

Houston, Texas, 77030

Site Contact

Manreet Kaur, MD

info@sublimitytherapeutics.com

713-798-1468

Biopharma Informatic, LLC, Houston, Texas

Status

Withdrawn

Address

Biopharma Informatic, LLC

Houston, Texas, 77043

Biopharma Informatic, LLC., Houston, Texas

Status

Recruiting

Address

Biopharma Informatic, LLC.

Houston, Texas, 77084

Site Contact

James Maher, III, MD

info@clinicalrc.net

281-944-3610

Rio Grande Gastroenterology, McAllen, Texas

Status

Withdrawn

Address

Rio Grande Gastroenterology

McAllen, Texas, 78503

HP Clinical Research, Bountiful, Utah

Status

Withdrawn

Address

HP Clinical Research

Bountiful, Utah, 84010

International Sites

Gomel Regional Clinical Hospital, Gomel, Belarus

Status

Recruiting

Address

Gomel Regional Clinical Hospital

Gomel, , 246 029

Site Contact

Elena Mikhailova, MD

info@sublimitytherapeutics.com

+375 296465206

Grodno Regional Clinical Hospital, Grodno, Belarus

Status

Recruiting

Address

Grodno Regional Clinical Hospital

Grodno, , 230017

Site Contact

Ruslan Yakubtsevich, MD

info@sublimitytherapeutics.com

+375 152434085

City Clinical Emergency Hospital, Minsk, Belarus

Status

Recruiting

Address

City Clinical Emergency Hospital

Minsk, , 220024

Site Contact

Natalia Silivontchik, MD

info@sublimitytherapeutics.com

+375 17 2878609

Minsk Regional Clinical Hospital, Minsk, Belarus

Status

Recruiting

Address

Minsk Regional Clinical Hospital

Minsk, , 223041

Site Contact

Aliaksandr Varabei, MD

info@sublimitytherapeutics.com

+375 17-265-22-13

MedConsult Pleven, Pleven, Bulgaria

Status

Recruiting

Address

MedConsult Pleven

Pleven, , 5800

Site Contact

Stefan Baydanov, MD

info@sublimitytherapeutics.com

+1 619-333-8911

UMHAT "Sveti Georgi", Plovdiv, Bulgaria

Status

Recruiting

Address

UMHAT "Sveti Georgi"

Plovdiv, , 4002

Site Contact

Aleksandar Petrov, MD

info@sublimitytherapeutics.com

+1 619-333-8911

Medical Center Asklepion, Sofia, Bulgaria

Status

Recruiting

Address

Medical Center Asklepion

Sofia, , 1303

Site Contact

Draganova Raina, MD

info@sublimitytherapeutics.com

+1 619-333-8911

UMBAL Tsaritsa Joanna ISUL, Sofia, Bulgaria

Status

Recruiting

Address

UMBAL Tsaritsa Joanna ISUL

Sofia, , 1527

Site Contact

Plamen Penchev, MD

info@sublimitytherapeutics.com

+359 29432103

Halifax, Nova Scotia, Canada

Status

Recruiting

Address

Dalhousie University - Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 2Y9

Site Contact

Jennifer Jones, MD

info@sublimitytherapeutics.com

+1 9024734638

London Health Sciences Centre, London, Ontario, Canada

Status

Recruiting

Address

London Health Sciences Centre

London, Ontario, N6A 5W9

Site Contact

Terry Ponich, MD

info@sublimitytherapeutics.com

+1 5196858500

Amiens, France

Status

Recruiting

Address

CHU Amiens Picardie - Service Hépato-Gastroentérologie

Amiens, , 80054

Site Contact

Mathurin Fumery, MD

fumery.mathurin@chu-amiens.fr

+1 619-333-8911

CHU DE MONTPELLIER - Hôpital St ELOI, Montpellier, France

Status

Recruiting

Address

CHU DE MONTPELLIER - Hôpital St ELOI

Montpellier, , 34295

Site Contact

Guillaume Pineton de Chambrun, MD

info@sublimitytherapeutics.com

+33 467330165

Saint-Étienne, France

Status

Recruiting

Address

CHU de Saint-Etienne - Service de Gastro-Entérologie-Hépatologie

Saint-Étienne, , 42055

Site Contact

Xavier Roblin, MD

xavier.roblin@chu-st-etienne.fr

+1 619-333-8911

Vandœuvre-lès-Nancy, France

Status

Recruiting

Address

Hôpital de Brabois Service d'Hépato-Gastro-Entérologie

Vandœuvre-lès-Nancy, , 54511

Site Contact

Laurent Peyrin-Biroulet, MD

info@sublimitytherapeutics.com

+33 383157459

Eugastro GmbH, Leipzig, Saxony, Germany

Status

Recruiting

Address

Eugastro GmbH

Leipzig, Saxony, 4103

Site Contact

Ingolf Schiefke, MD

info@sublimitytherapeutics.com

+49 3414935720

Berlin, Germany

Status

Recruiting

Address

Krankenhaus Walfriede, Akademisches Lehrkrankenhaus der Charite

Berlin, , 14163

Site Contact

Carsten Büning, MD

info@sublimitytherapeutics.com

+49 3081810243

Hannover, Germany

Status

Recruiting

Address

Medizinische Hochschule Hannover, Klinik für Gastroenterologie, Hepatologie und Endokrinologie, Zentrym für Innere Medizin

Hannover, , 30625

Site Contact

Ursula Seidler, MD

info@sublimitytherapeutics.com

+49 5115323306

Leipzig, Germany

Status

Recruiting

Address

Universität Leipzig, Klinik f. Gastroenterologie und Rheumatologie

Leipzig, , 4103

Site Contact

Martin Hecker, MD

info@sublimitytherapeutics.com

+49 89375089938

DRC Gyógyszervizsgáló Központ Kft., Balatonfüred, Hungary

Status

Recruiting

Address

DRC Gyógyszervizsgáló Központ Kft.

Balatonfüred, , 8230

Site Contact

Istvan Szita, MD

info@sublimitytherapeutics.com

+36 87481616

Semmelweis University, Budapest, Hungary

Status

Recruiting

Address

Semmelweis University

Budapest, , 1088

Site Contact

Zsolt Tulassay, MD

info@sublimitytherapeutics.com

+36 14530980

Budapest, Hungary

Status

Recruiting

Address

Semmelweis University, AOK Varosmajori Sziv- es Ergyogyaszati Klinika,

Budapest, , H-1031

Site Contact

Gyula G Kiss, MD

info@sublimitytherapeutics.com

+36 203997844

Bugat Pal Hospital, Gyongyos, Hungary

Status

Recruiting

Address

Bugat Pal Hospital

Gyongyos, , 3200

Site Contact

Gyula Horvat, MD

info@sublimitytherapeutics.com

+36 37397833

Szent Borbála County Hospital, Tatabánya, Hungary

Status

Withdrawn

Address

Szent Borbála County Hospital

Tatabánya, , 2800

Cork University Hospital, Cork, Ireland

Status

Withdrawn

Address

Cork University Hospital

Cork, ,

Mater Misericordiae University Hospital, Dublin, Ireland

Status

Recruiting

Address

Mater Misericordiae University Hospital

Dublin, , D07 RX49

Site Contact

Jen Leyden, MD

info@sublimitytherapeutics.com

+353 7164596

St. James's Hospital, Dublin, Ireland

Status

Recruiting

Address

St. James's Hospital

Dublin, ,

Site Contact

David Kevans, MD

info@sublimitytherapeutics.com

+353 14103931

Afula, Israel

Status

Recruiting

Address

Gastroenterology Institute, Emek Medical Center

Afula, , 1834111

Site Contact

Eran Zittan, MD

info@sublimitytherapeutics.com

+972 46495609

Barzilai Medical Center, Ashkelon, Israel

Status

Recruiting

Address

Barzilai Medical Center

Ashkelon, , 7830604

Site Contact

Ofer Ben Bassat, MD

info@sublimitytherapeutics.com

+972 86745468

Clalit Health Services Jerusalem, Jerusalem, Israel

Status

Recruiting

Address

Clalit Health Services Jerusalem

Jerusalem, , 9362410

Site Contact

Dan Keret, MD

info@sublimitytherapeutics.com

+97225457100

Kfar Saba, Israel

Status

Recruiting

Address

Institute of Gastroenterology, Meir Medical Center

Kfar Saba, , 4428164

Site Contact

Timna Naftali, MD

info@sublimitytherapeutics.com

+972 97471017

Humanitas Research Hospital, IBD Center, Milan, Italy

Status

Recruiting

Address

Humanitas Research Hospital, IBD Center

Milan, , 20089

Site Contact

Silvio Danese, MD

info@sublimitytherapeutics.com

+39 3383014832

Pavia, Italy

Status

Recruiting

Address

Fondazione IRCCS Policlinico San Matteo - Medicina Generale I

Pavia, , 27100

Site Contact

Antonio Di Sabatino, MD

info@sublimitytherapeutics.com

+39 236637105

ASST Rhodense - Ospedale di Rho, Rho, Italy

Status

Recruiting

Address

ASST Rhodense - Ospedale di Rho

Rho, , 20017

Site Contact

Simone Saibeni, MD

info@sublimitytherapeutics.com

+39 3479922595

San Giovanni Rotondo, Italy

Status

Recruiting

Address

Fondazione Casa Sollievo della Sofferenza

San Giovanni Rotondo, , 71013

Site Contact

Fabrizio Bossa, MD

info@sublimitytherapeutics.com

+39 236637105

Centrum Opieki Zdrowotnej Orkan-med, Ksawerów, Poland

Status

Recruiting

Address

Centrum Opieki Zdrowotnej Orkan-med

Ksawerów, , 95-054

Site Contact

Krystyna Stec-Michalska, MD

info@sublimitytherapeutics.com

+48 226161488

Klinika Gastroenterologii, Lodz, Poland

Status

Recruiting

Address

Klinika Gastroenterologii

Lodz, , 90-647

Site Contact

Anita Gasiorowska, MD

info@sublimitytherapeutics.com

+48 226161488

Medicome Sp. z o.o., Oświęcim, Poland

Status

Recruiting

Address

Medicome Sp. z o.o.

Oświęcim, , 32600

Site Contact

Witold Zmuda, MD

info@sublimitytherapeutics.com

+48 226161488

Centrum Medyczne Medyk, Rzeszów, Poland

Status

Recruiting

Address

Centrum Medyczne Medyk

Rzeszów, , 35-526

Site Contact

Rafal Filip, MD

info@sublimitytherapeutics.com

+48 509130097

Endoskopia sp. z o.o., Sopot, Poland

Status

Recruiting

Address

Endoskopia sp. z o.o.

Sopot, , 81-756

Site Contact

Marek Horynski, MD

info@sublimitytherapeutics.com

+48 226161488

WIP Warsaw IBD Point Profesor Kierkus, Warszawa, Poland

Status

Recruiting

Address

WIP Warsaw IBD Point Profesor Kierkus

Warszawa, , 00-728

Site Contact

Jaroslaw Kierkus, MD

info@sublimitytherapeutics.com

+48 226161488

Łódź, Poland

Status

Recruiting

Address

Oddział Kliniczny Gastroenterologii Ogólnej i Onkologicznej SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego UM

Łódź, , 90-153

Site Contact

Ewa Małecka-Panas, MD

info@sublimitytherapeutics.com

+48 226161488

MedLife Grivita, Bucharest, Romania

Status

Recruiting

Address

MedLife Grivita

Bucharest, , 010719

Site Contact

Ion Eugeniu Craciun, MD

eugencraciun@yahoo.com

+1 619-333-8911

Colentina Clinical Hospital, Bucharest, Romania

Status

Recruiting

Address

Colentina Clinical Hospital

Bucharest, , 020125

Site Contact

Radu Bogdan Mateescu, MD

info@sublimitytherapeutics.com

+40 213152590

University Hospital Bucharest, Bucharest, Romania

Status

Recruiting

Address

University Hospital Bucharest

Bucharest, , 050098

Site Contact

Lucian Negreanu, MD

info@sublimitytherapeutics.com

+40 722546405

Medical Center Tuculanu, Timişoara, Romania

Status

Recruiting

Address

Medical Center Tuculanu

Timişoara, , 300158

Site Contact

Daniel Tuculanu, MD

info@sublimitytherapeutics.com

+ 40 737502190

Federal State Center of Coloproctology, Moscow, Russian Federation

Status

Recruiting

Address

Federal State Center of Coloproctology

Moscow, , 123423

Site Contact

Alexey Veselov, MD

info@sublimitytherapeutics.com

+7 9067676741

LLC Medical center Healthy family, Novosibirsk, Russian Federation

Status

Recruiting

Address

LLC Medical center Healthy family

Novosibirsk, , 630099

Site Contact

Natalya Voloshina, MD

info@sublimitytherapeutics.com

+7 9137575967

Military Medical Academy, Saint Petersburg, Russian Federation

Status

Recruiting

Address

Military Medical Academy

Saint Petersburg, , 191 124

Site Contact

Alexander Gordienko, MD

info@sublimitytherapeutics.com

+7 9523666484

Alliance Biomedical - Russian Group, LLC, Saint Petersburg, Russian Federation

Status

Recruiting

Address

Alliance Biomedical - Russian Group, LLC

Saint Petersburg, , 191014

Site Contact

Evgeny Soldatskiy, MD

info@sublimitytherapeutics.com

+7 9075008140

Saint Petersburg, Russian Federation

Status

Recruiting

Address

North-Western State Medical University n.a. I.I.Mechnikov

Saint Petersburg, , 191015

Site Contact

Igor Bakulin, MD

info@sublimitytherapeutics.com

+7 8125439318

Saint Petersburg, Russian Federation

Status

Recruiting

Address

Scientific Research Center Eco-Safety LLC

Saint Petersburg, , 196143

Site Contact

Vasily Vasilyuk, MD

info@sublimitytherapeutics.com

+7 9319683215

Saint Petersburg, Russian Federation

Status

Recruiting

Address

Pavlov First Saint Petersburg State Medical University

Saint Petersburg, , 197022

Site Contact

Vasily Trofimov, MD

info@sublimitytherapeutics.com

+7 9533503467

Saint-Petersburg, Russian Federation

Status

Recruiting

Address

Saint-Petersburg State Medical Academy n.a. I.I. Mechnikov of Federal Agency of Healthcare & Social Development

Saint-Petersburg, , 195067

Site Contact

Yury Uspenskiy, MD

info@sublimitytherapeutics.com

+7 9052096001

Samara, Russian Federation

Status

Recruiting

Address

Non state Public Health Institution "Railway clinical hospital on station Samara" of joint stock company Russian railways

Samara, , 403029

Site Contact

Pavel Andreev, MD

info@sublimitytherapeutics.com

+7 8123095457

Saratov State Medical University, Saratov, Russian Federation

Status

Recruiting

Address

Saratov State Medical University

Saratov, , 410054

Site Contact

Yury Shvarts, MD

info@sublimitytherapeutics.com

+7 8452560295

Siberia State Medical University, Tomsk, Russian Federation

Status

Recruiting

Address

Siberia State Medical University

Tomsk, , 630055

Site Contact

Ekaterina Bukreeva, MD

info@sublimitytherapeutics.com

+7 9039524868

Clinical Center Zvezdara, Belgrade, Serbia

Status

Recruiting

Address

Clinical Center Zvezdara

Belgrade, , 11000

Site Contact

Peter Svorcan, MD

info@sublimitytherapeutics.com

+381 638022266

Belgrade, Serbia

Status

Recruiting

Address

Clinical-Hospital Centre Bezanijska Kosa - Gastroenterology Department

Belgrade, , 11080

Site Contact

Igor Jovanovic, MD

info@sublimitytherapeutics.com

+381 113010700

Belgrad, Serbia

Status

Recruiting

Address

Clinical Hospital Center "Dr Dragisa Misovic-Dedinje"

Belgrad, , 11000

Site Contact

Branka Filipovic, MD

info@sublimitytherapeutics.com

+381 113538700

Clinical Center Kragujevac, Kragujevac, Serbia

Status

Recruiting

Address

Clinical Center Kragujevac

Kragujevac, , 34000

Site Contact

Natasa Zdravkovic-Petrovic, MD

info@sublimitytherapeutics.com

+381 113538700

IDIBGI, Hospital Trueta, Girona, Spain

Status

Recruiting

Address

IDIBGI, Hospital Trueta

Girona, , 17007

Site Contact

Xavier Aldeguer Mante, MD

info@sublimitytherapeutics.com

+34 972940200

Sevilla, Spain

Status

Recruiting

Address

Hospital Universitario Virgen de la Macarena

Sevilla, , 41009

Site Contact

Federico Arguelles Arias, MD

info@sublimitytherapeutics.com

+34 600162109

Chernivtsi Regional Clinical Hospital, Chernivtsi, Ukraine

Status

Recruiting

Address

Chernivtsi Regional Clinical Hospital

Chernivtsi, , 58001

Site Contact

Oleksandr Fediv, MD

info@sublimitytherapeutics.com

+380 674800982

Ivano-Frankivsk, Ukraine

Status

Recruiting

Address

Ivano-Frankivsk National Medical University, Regional Clinical Hospital

Ivano-Frankivsk, , 76008

Site Contact

Vira Vyshyvanyuk, MD

info@sublimitytherapeutics.com

+38 342528010

Kharkiv, Ukraine

Status

Recruiting

Address

Kharkiv City Clinical Hospital No 2 n.a. prof. O.O.Shalimov

Kharkiv, , 61037

Site Contact

Olena Datsenko, MD

info@sublimitytherapeutics.com

+380 674416147

Kiev City Clinical Hospital No. 1, Kiev, Ukraine

Status

Recruiting

Address

Kiev City Clinical Hospital No. 1

Kiev, , 2091

Site Contact

Inna Markevych, MD

info@sublimitytherapeutics.com

+38 0962274476

Kyiv, Ukraine

Status

Recruiting

Address

Communal Institution of Kyiv Regional Council "Kyiv Regional Clinical Hospital"

Kyiv, , 04107

Site Contact

Volodymyr Pyrogovskyy, MD

info@sublimitytherapeutics.com

+380 676968964

Kyiv, Ukraine

Status

Recruiting

Address

Ukrainian-German Gastroenterology Center "BYK-Kyiv"

Kyiv, , 1030

Site Contact

Andriy Dorofeyev, MD

info@sublimitytherapeutics.com

+38 0442359173

Volyn Regional Clinical Hospital, Lutsk, Ukraine

Status

Recruiting

Address

Volyn Regional Clinical Hospital

Lutsk, , 43000

Site Contact

Dmytro Shulga, MD

info@sublimitytherapeutics.com

+38 0958969484

Lviv, Ukraine

Status

Recruiting

Address

Communal Nonprofit Enterprise "Lviv Clinical Emergency Care Hospital"

Lviv, , 79059

Site Contact

Valeriy Vdovychenko, MD

info@sublimitytherapeutics.com

+38 0951058009

Lviv, Ukraine

Status

Recruiting

Address

Communal Nonprofit Entreprise, "Lviv Clinical Emergency Care Hospital", 1st Therapeutic Dpt

Lviv, , 79059

Site Contact

Mykola Bychkov, MD

info@sublimitytherapeutics.com

+1 619-333-8911

Odesa, Ukraine

Status

Recruiting

Address

Communal Nonprofit Enterprise "Odesa Regional Clinical Hospital"

Odesa, , 65025

Site Contact

Andriy Yurkiv, MD

info@sublimitytherapeutics.com

+38 0674810508

Ternopil, Ukraine

Status

Recruiting

Address

Communal Nonprofit Enterprise "Ternopil University Hospital" of Ternopil Regional Council

Ternopil, , 46002

Site Contact

Ihor Hospodarskyy, MD

info@sublimitytherapeutics.com

+38 0509564218

Uzhhorod, Ukraine

Status

Recruiting

Address

Municipal Institution "Uzhhorod Central District Hospital"

Uzhhorod, , 88009

Site Contact

Ivan Chopey, MD

info@sublimitytherapeutics.com

+380 31266494

Medical Center "Health Clinic", Vinnytsia, Ukraine

Status

Recruiting

Address

Medical Center "Health Clinic"

Vinnytsia, , 21000

Site Contact

Oleksandr Golovchenko, MD

info@sublimitytherapeutics.com

+380 982267838

Vinnytsia, Ukraine

Status

Recruiting

Address

Communal Non-profit Enterprise "Vinnytsia City Clinical Hospital #1"

Vinnytsia, , 21029

Site Contact

Halyna Tomashkevych, MD

info@sublimitytherapeutics.com

+38 0673324732

Addenbrooke's Hospital, Cambridge, Cambridgeshire, United Kingdom

Status

Recruiting

Address

Addenbrooke's Hospital

Cambridge, Cambridgeshire, CB2 0QQ

Site Contact

Miles Parkes, MD

info@sublimitytherapeutics.com

+44 1223596461

Belfast, Co Antrim, United Kingdom

Status

Recruiting

Address

South Eastern Health & Social Care Trust, Ulster Hospital

Belfast, Co Antrim, BT161RH

Site Contact

Patrick Allen, MD

info@sublimitytherapeutics.com

+44 7713390302

Liverpool, Merseyside, United Kingdom

Status

Recruiting

Address

Royal Liverpool & Broadgreen University Hospitals NHS Trust

Liverpool, Merseyside, L7 8XP

Site Contact

Philip Smith, MD

info@sublimitytherapeutics.com

+44 1517064194

Birmingham, Warwickshire, United Kingdom

Status

Recruiting

Address

Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust

Birmingham, Warwickshire, B15 2TH

Site Contact

Tariq Iqbal, MD

info@sublimitytherapeutics.com

+44 1213718749

Coventry, Warwickshire, United Kingdom

Status

Withdrawn

Address

University Hospitals Coventry & Warwickshire NHS Trust

Coventry, Warwickshire, CV2 2DX

Barnsley Hospital NHS Foundation Trust, Barnsley, Yorkshire, United Kingdom

Status

Recruiting

Address

Barnsley Hospital NHS Foundation Trust

Barnsley, Yorkshire, S75 2EP

Site Contact

Robert Atkinson, MD

info@sublimitytherapeutics.com

+44 1226435084

London, United Kingdom

Status

Recruiting

Address

King's College Hospital NHS Foundation Trust

London, , SE59RS

Site Contact

Guy Chung-Faye, MD

info@sublimitytherapeutics.com

+44 2032991435

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