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 |
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.
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.
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 |
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
Experimental: ST-0529 18.75 mg*
ST-0529: 18.75 mg orally twice daily (BID) *Jan 2021 update: following the IDMC recommendation, this arm has been dropped
Experimental: ST-0529 37.5 mg*
ST-0529: 37.5 mg orally twice daily (BID) *Jan 2021 update: following the IDMC recommendation, this arm has been dropped
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.
Status
Withdrawn
Address
Sharp Chula Vista eStudy Site
Chula Vista, California, 91911
Status
Recruiting
Address
Palmtree Clinical Research Inc
Palm Springs, California, 92262
Status
Withdrawn
Address
Alliance Clinical Research
Poway, California, 92064
Status
Withdrawn
Address
Gastro Florida
Clearwater, Florida, 33756
Status
Recruiting
Address
Advanced Research Institute
Largo, Florida, 33377
Status
Recruiting
Address
Advanced Research Institute, Inc.
New Port Richey, Florida, 34653
Status
Recruiting
Address
Endoscopic Research Inc
Orlando, Florida, 32803
Status
Withdrawn
Address
Meridien Research
Spring Hill, Florida, 34609
Status
Recruiting
Address
University of Chicago
Chicago, Illinois, 60637
Status
Withdrawn
Address
IU Research, an Affiliate of Aerotek, Division of Gastroenterology/Hepatology
Indianapolis, Indiana, 46202
Status
Withdrawn
Address
Houma Digestive Health Specialists, LLC
Houma, Louisiana, 70360
Status
Withdrawn
Address
Capitol Research
Rockville, Maryland, 20850
Status
Recruiting
Address
AGA Clinical Reasearch Associates, LLC
Egg Harbor Township, New Jersey, 08234
Status
Withdrawn
Address
Charlotte Gastroenterology & Hepatology, PLLC
Charlotte, North Carolina, 28207
Status
Withdrawn
Address
Consultants for Clinical Research
Cincinnati, Ohio, 45219
Status
Withdrawn
Address
Vanderbilt University Medical Center
Nashville, Tennessee, 37212-1375
Status
Withdrawn
Address
Spring Gastroenterology Associates
Houston, Texas, 77002
Status
Recruiting
Address
Baylor College of Medicine
Houston, Texas, 77030
Status
Withdrawn
Address
Biopharma Informatic, LLC
Houston, Texas, 77043
Status
Recruiting
Address
Biopharma Informatic, LLC.
Houston, Texas, 77084
Status
Withdrawn
Address
Rio Grande Gastroenterology
McAllen, Texas, 78503
Status
Withdrawn
Address
HP Clinical Research
Bountiful, Utah, 84010
International Sites
Status
Recruiting
Address
Gomel Regional Clinical Hospital
Gomel, , 246 029
Status
Recruiting
Address
Grodno Regional Clinical Hospital
Grodno, , 230017
Status
Recruiting
Address
City Clinical Emergency Hospital
Minsk, , 220024
Status
Withdrawn
Address
Minsk Regional Clinical Hospital
Minsk, , 223041
Status
Recruiting
Address
MedConsult Pleven
Pleven, , 5800
Status
Withdrawn
Address
UMHAT "Sveti Georgi"
Plovdiv, , 4002
Status
Recruiting
Address
Medical Center Asklepion
Sofia, , 1303
Status
Recruiting
Address
UMBAL Tsaritsa Joanna ISUL
Sofia, , 1527
Status
Recruiting
Address
Dalhousie University - Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9
Status
Recruiting
Address
London Health Sciences Centre
London, Ontario, N6A 5W9
Status
Recruiting
Address
CHU Amiens Picardie - Service Hépato-Gastroentérologie
Amiens, , 80054
Status
Recruiting
Address
CHU DE MONTPELLIER - Hôpital St ELOI
Montpellier, , 34295
Status
Recruiting
Address
CHU de Saint-Etienne - Service de Gastro-Entérologie-Hépatologie
Saint-Étienne, , 42055
Status
Recruiting
Address
Hôpital de Brabois Service d'Hépato-Gastro-Entérologie
Vandœuvre-lès-Nancy, , 54511
Status
Recruiting
Address
Eugastro GmbH
Leipzig, Saxony, 4103
Status
Recruiting
Address
Medizinische Klinik für Gastroenterologie, Infektiologie, Rheumatologie charite
Berlin, , 12203
Status
Recruiting
Address
Krankenhaus Walfriede, Akademisches Lehrkrankenhaus der Charite
Berlin, , 14163
Status
Recruiting
Address
Agaplesion Markus Krankenhaus Medizinischen Klinik I, Gastroenterologie, Hepatologie, Onkologie, lnfektiologie
Frankfurt, , 60431
Status
Recruiting
Address
Universitatsklinikum Freiburg, Medizinische Klinik
Freiburg, , 79106
Status
Recruiting
Address
Medizinische Hochschule Hannover, Klinik für Gastroenterologie, Hepatologie und Endokrinologie, Zentrym für Innere Medizin
Hannover, , 30625
Status
Recruiting
Address
Klinik für Gastroenterologie, Pulmologie und allg. lnnere Medizin
Köln, , 5103
Status
Recruiting
Address
Universität Leipzig, Klinik f. Gastroenterologie und Rheumatologie
Leipzig, , 4103
Status
Recruiting
Address
Gastroenterologische Gemeinschaftspraxis Minden
Minden, , 32123
Status
Recruiting
Address
DRC Gyógyszervizsgáló Központ Kft.
Balatonfüred, , 8230
Status
Recruiting
Address
Semmelweis University
Budapest, , 1088
Status
Recruiting
Address
Semmelweis University, AOK Varosmajori Sziv- es Ergyogyaszati Klinika,
Budapest, , H-1031
Status
Recruiting
Address
Bugat Pal Hospital
Gyongyos, , 3200
Status
Withdrawn
Address
Szent Borbála County Hospital
Tatabánya, , 2800
Status
Withdrawn
Address
Cork University Hospital
Cork, ,
Status
Recruiting
Address
Mater Misericordiae University Hospital
Dublin, , D07 RX49
Status
Recruiting
Address
St. James's Hospital
Dublin, ,
Status
Recruiting
Address
Gastroenterology Institute, Emek Medical Center
Afula, , 1834111
Status
Recruiting
Address
Barzilai Medical Center
Ashkelon, , 7830604
Status
Recruiting
Address
Clalit Health Services Jerusalem
Jerusalem, , 9362410
Status
Recruiting
Address
Institute of Gastroenterology, Meir Medical Center
Kfar Saba, , 4428164
Status
Recruiting
Address
Humanitas Research Hospital, IBD Center
Milan, , 20089
Status
Recruiting
Address
A.0.U. di Modena - Policlinico S.C. di Gastroenterologia
Modena, , 41124
Status
Recruiting
Address
Fondazione IRCCS Policlinico San Matteo - Medicina Generale I
Pavia, , 27100
Status
Recruiting
Address
ASST Rhodense - Ospedale di Rho
Rho, , 20017
Status
Recruiting
Address
Fondazione Casa Sollievo della Sofferenza
San Giovanni Rotondo, , 71013
Status
Recruiting
Address
Centrum Opieki Zdrowotnej Orkan-med
Ksawerów, , 95-054
Status
Withdrawn
Address
Klinika Gastroenterologii
Lodz, , 90-647
Status
Recruiting
Address
Medicome Sp. z o.o.
Oświęcim, , 32600
Status
Recruiting
Address
Centrum Medyczne Medyk
Rzeszów, , 35-526
Status
Recruiting
Address
Endoskopia sp. z o.o.
Sopot, , 81-756
Status
Recruiting
Address
WIP Warsaw IBD Point Profesor Kierkus
Warszawa, , 00-728
Status
Recruiting
Address
Oddział Kliniczny Gastroenterologii Ogólnej i Onkologicznej SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego UM
Łódź, , 90-153
Status
Recruiting
Address
MedLife Grivita
Bucharest, , 010719
Status
Recruiting
Address
Colentina Clinical Hospital
Bucharest, , 020125
Status
Recruiting
Address
University Hospital Bucharest
Bucharest, , 050098
Status
Withdrawn
Address
Medical Center Tuculanu
Timişoara, , 300158
Status
Recruiting
Address
Federal State Center of Coloproctology
Moscow, , 123423
Status
Recruiting
Address
LLC Medical center Healthy family
Novosibirsk, , 630099
Status
Recruiting
Address
Military Medical Academy
Saint Petersburg, , 191 124
Status
Withdrawn
Address
Alliance Biomedical - Russian Group, LLC
Saint Petersburg, , 191014
Status
Recruiting
Address
North-Western State Medical University n.a. I.I.Mechnikov
Saint Petersburg, , 191015
Status
Recruiting
Address
Scientific Research Center Eco-Safety LLC
Saint Petersburg, , 196143
Status
Recruiting
Address
Pavlov First Saint Petersburg State Medical University
Saint Petersburg, , 197022
Status
Recruiting
Address
Saint-Petersburg State Medical Academy n.a. I.I. Mechnikov of Federal Agency of Healthcare & Social Development
Saint-Petersburg, , 195067
Status
Recruiting
Address
Non state Public Health Institution "Railway clinical hospital on station Samara" of joint stock company Russian railways
Samara, , 403029
Status
Recruiting
Address
Saratov State Medical University
Saratov, , 410054
Status
Recruiting
Address
Siberia State Medical University
Tomsk, , 630055
Status
Recruiting
Address
Clinical Center Zvezdara
Belgrade, , 11000
Status
Recruiting
Address
Clinical-Hospital Centre Bezanijska Kosa - Gastroenterology Department
Belgrade, , 11080
Status
Recruiting
Address
Clinical Hospital Center "Dr Dragisa Misovic-Dedinje"
Belgrad, , 11000
Status
Recruiting
Address
Clinical Center Kragujevac
Kragujevac, , 34000
Status
Withdrawn
Address
IDIBGI, Hospital Trueta
Girona, , 17007
Status
Recruiting
Address
Hospital Universitario Virgen de la Macarena
Sevilla, , 41009
Status
Recruiting
Address
Chernivtsi Regional Clinical Hospital
Chernivtsi, , 58001
Status
Recruiting
Address
Ivano-Frankivsk National Medical University, Regional Clinical Hospital
Ivano-Frankivsk, , 76008
Status
Recruiting
Address
Kharkiv City Clinical Hospital No 2 n.a. prof. O.O.Shalimov
Kharkiv, , 61037
Status
Recruiting
Address
Kiev City Clinical Hospital No. 1
Kiev, , 2091
Status
Recruiting
Address
Communal Institution of Kyiv Regional Council "Kyiv Regional Clinical Hospital"
Kyiv, , 04107
Status
Recruiting
Address
Ukrainian-German Gastroenterology Center "BYK-Kyiv"
Kyiv, , 1030
Status
Recruiting
Address
Volyn Regional Clinical Hospital
Lutsk, , 43000
Status
Recruiting
Address
Communal Nonprofit Enterprise "Lviv Clinical Emergency Care Hospital"
Lviv, , 79059
Status
Recruiting
Address
Communal Nonprofit Entreprise, "Lviv Clinical Emergency Care Hospital", 1st Therapeutic Dpt
Lviv, , 79059
Status
Recruiting
Address
Communal Nonprofit Enterprise "Odesa Regional Clinical Hospital"
Odesa, , 65025
Status
Recruiting
Address
Communal Nonprofit Enterprise "Ternopil University Hospital" of Ternopil Regional Council
Ternopil, , 46002
Status
Recruiting
Address
Municipal Institution "Uzhhorod Central District Hospital"
Uzhhorod, , 88009
Status
Recruiting
Address
Medical Center "Health Clinic"
Vinnytsia, , 21000
Status
Recruiting
Address
Communal Non-profit Enterprise "Vinnytsia City Clinical Hospital #1"
Vinnytsia, , 21029
Status
Recruiting
Address
Addenbrooke's Hospital
Cambridge, Cambridgeshire, CB2 0QQ
Status
Recruiting
Address
South Eastern Health & Social Care Trust, Ulster Hospital
Belfast, Co Antrim, BT161RH
Status
Recruiting
Address
Royal Liverpool & Broadgreen University Hospitals NHS Trust
Liverpool, Merseyside, L7 8XP
Status
Recruiting
Address
Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust
Birmingham, Warwickshire, B15 2TH
Status
Withdrawn
Address
University Hospitals Coventry & Warwickshire NHS Trust
Coventry, Warwickshire, CV2 2DX
Status
Recruiting
Address
Barnsley Hospital NHS Foundation Trust
Barnsley, Yorkshire, S75 2EP
Status
Recruiting
Address
University College London Hospital NHS Foundation Trust
London, , NWI 2BU
Status
Recruiting
Address
King's College Hospital NHS Foundation Trust
London, , SE59RS