A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 6 Weeks in Adults With Ulcerative Colitis

Study Purpose

The primary objective of this study is to evaluate the effect of GLPG3970 compared to placebo on the signs and symptoms of Ulcerative Colitis (UC) in participants with moderately to severely active UC.

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 - 64 Years
Gender All
More Inclusion & Exclusion Criteria

Key

Inclusion Criteria:

1. Documented diagnosis of UC of ≥3 months. The criteria for documentation of UC diagnosis based on endoscopy will be medical record documentation, and/or a colonoscopy report dated ≥3 months before screening, which shows features consistent with UC. 2. Treatment-experienced participants with moderately to severely active disease, who have either previously demonstrated inadequate clinical response, loss of response, or intolerance to at least 1 course of standard-of-care (SoC) therapy for UC (i.e. steroids [oral or parenteral, including but not limited to prednisone, prednisolone, budesonide], 5-aminosalicylate (5- ASA) derivatives [including but not limited to mesalamine, sulfasalazine], anti-metabolites [including but not limited to azathioprine, 6 mercaptopurine, methotrexate], anti-tumor necrosis factor (TNF) agents, anti-integrins, Janus kinase (JAK) inhibitors), as confirmed by the investigator. 3. Moderately to severely active UC as determined at screening by: 1. Centrally-read endoscopic evidence of disease activity (MCS- endoscopy subscore (ES) ≥2 OR ulcerative colitis endoscopic index of severity (UCEIS) ≥4) with a minimum disease extent of 15 cm from anal verge; AND. 2. MCS stool frequency (SF) subscore ≥1; AND. 3. MCS rectal bleeding (RB) subscore ≥1. 4. Participants currently receiving the following SoC therapies for UC are eligible providing they have been on a stable dose for the designated period of time and are anticipated to be stable throughout the study: 1. oral corticosteroids (prednisone ≤20 mg/day or equivalent or budesonide ≤3 mg/day) stable dose for at least 2 weeks prior to first investigational product (IP) dosing. 2. oral 5-ASA compounds (mesalamine ≤4 g/day or sulfasalazine ≤4 g/day) stable dose for at least 4 weeks prior to first IP dosing. 3. oral thiopurines (azathioprine ≤2.5 mg/kg/day and 6-mercaptopurine 1.5 mg/kg/day) stable dose for at least 12 weeks prior to first IP dosing, or methotrexate ≤20 mg/week, stable dose for at least 12 weeks prior to first IP dosing. Key

Exclusion Criteria:

1. Diagnosis of Crohn's disease, indeterminate colitis, ischemic colitis, fulminant colitis, or toxic megacolon. 2. Prior surgical intervention for UC (e.g. colectomy, partial colectomy, ileostomy or colostomy) or likely requirement for surgery for UC, during the study. 3. History or evidence of incompletely resected colonic mucosal dysplasia. 4. Exhibit acute severe UC per the following criteria: 1. bloody diarrhea ≥6/day AND. 2. any of the following signs of systemic toxicity: Body temperature (oral or tympanic) ≥37.8°C OR Resting pulse (after 5 min seated position) >90 beats per min OR hemoglobin <105 g/L, OR erythrocyte sedimentation rate >30 mm/h; OR C-reactive protein (CRP) >30 mg/L. 5. Screening stool sample positive for ova and/or parasites, Clostridium difficile toxin, Escherichia coli, Salmonella species (spp), Shigella spp, Campylobacter spp or Yersinia spp. 6. Participant testing positive at screening for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection as detected by real time polymerase chain reaction (RT-PCR), participants presenting any signs or symptoms as detected at baseline following careful physical examination (e.g. cough, fever, headaches, fatigue, dyspnea, myalgia, anosmia, dysgeusia, anorexia, sore throat, others) or reporting any signs and symptoms for the preceding 2 weeks, or participants who have been exposed to individuals with confirmed or suspected diagnosis of SARS-CoV-2 within 2 weeks prior to baseline. In addition, any other locally applicable standard diagnostic criteria may also apply to rule out SARS-CoV-2 infection. Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

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.

NCT04577794
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.

Galapagos NV
Principal Investigator

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

Roxana Drake
Principal Investigator Affiliation Galapagos NV
Agency Class

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

Industry
Overall Status Recruiting
Countries Georgia, Moldova, Republic of, Poland, Ukraine
Conditions

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

Ulcerative Colitis
Arms & Interventions

Arms

Experimental: GLPG3970

Participants will receive GLPG3970 solution, orally, once daily for 6 weeks

Placebo Comparator: Placebo

Participants will receive placebo solution, orally, once daily for 6 weeks.

Interventions

Drug: - GLPG3970

GLPG3970 powder and solvent for oral solution to be reconstituted prior to use.

Drug: - Placebo

Placebo powder and solvent for oral solution to be reconstituted prior to use.

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.

International Sites

Arensia Exploratory Medicine LLC, Tbilisi, Georgia

Status

Recruiting

Address

Arensia Exploratory Medicine LLC

Tbilisi, , 0112

Chisinau, Moldova, Republic of

Status

Recruiting

Address

ARENSIA Exploratory Medicine Phase I Unit

Chisinau, , 2025

Centrum Medyczne PROMED, Kraków, Poland

Status

Recruiting

Address

Centrum Medyczne PROMED

Kraków, , 31-513

Endoskopia Sp. z o.o., Sopot, Poland

Status

Recruiting

Address

Endoskopia Sp. z o.o.

Sopot, , 81-756

ETG Zamosc, Zamość, Poland

Status

Recruiting

Address

ETG Zamosc

Zamość, , 22-400

Dnipro, Ukraine

Status

Recruiting

Address

I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital

Dnipro, , 49005

Ivano-Frankivs'k, Ukraine

Status

Recruiting

Address

Ivano-Frankivsk Regional Clinical Hospital

Ivano-Frankivs'k, , 76000

Kharkiv, Ukraine

Status

Recruiting

Address

CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2

Kharkiv, , 61037

CHI Kharkiv City Clinical Hospital #13, Kharkiv, Ukraine

Status

Recruiting

Address

CHI Kharkiv City Clinical Hospital #13

Kharkiv, , 61124

Kherson, Ukraine

Status

Recruiting

Address

Communal Nonprofit Enterprise Kherson City Clinical Hospital n.a. Afanasii and Olga Tropini

Kherson, , 73000

Medical Center "Harmoniya Krasy", Kyiv, Ukraine

Status

Recruiting

Address

Medical Center "Harmoniya Krasy"

Kyiv, , 01135

Kyiv, Ukraine

Status

Recruiting

Address

Med Center 'Ok!Clinic+' of International Institute of Clinical Trials LLC

Kyiv, , 02091

Vinnytsia, Ukraine

Status

Recruiting

Address

M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU

Vinnytsia, , 21018

Vinnytsia, Ukraine

Status

Recruiting

Address

CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM

Vinnytsia, , 21029

Vinnytsia, Ukraine

Status

Recruiting

Address

SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU

Vinnytsia, , 21029

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