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

NCT ID: NCT04577794

Last Updated: 2023-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-05
• Study Completion Date: 2021-05-31

Brief Summary

The primary objective of this study was 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.

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

GLPG3970

Participants received 400 milligrams (mg) GLPG3970 oral solution, once daily (QD) for a period of 6 weeks.

Group Type: EXPERIMENTAL

GLPG3970

Intervention Type: DRUG

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

Placebo

Participants received GLPG3970 matching placebo oral solution, QD for a period of 6 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

GLPG3970

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

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 grams [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/kilograms [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.

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 degrees celsius (°C) OR Resting pulse (after 5 min seated position) >90 beats per min OR hemoglobin <105 g/L, OR erythrocyte sedimentation rate >30 millimeters per hour (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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Galapagos NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Galapagos Medical Director

Role: STUDY_DIRECTOR

Galapagos NV

Locations

Arensia Exploratory Medicine LLC

Tbilisi, , Georgia

ARENSIA Exploratory Medicine Phase I Unit

Chisinau, , Moldova

Centrum Medyczne PROMED

Krakow, , Poland

Endoskopia Sp. z o.o.

Sopot, , Poland

ETG Zamosc

Zamość, , Poland

I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital

Dnipro, , Ukraine

Ivano-Frankivsk Regional Clinical Hospital

Ivano-Frankivsk, , Ukraine

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

Kharkiv, , Ukraine

CHI Kharkiv City Clinical Hospital #13

Kharkiv, , Ukraine

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

Kherson, , Ukraine

Medical Center "Harmoniya Krasy"

Kyiv, , Ukraine

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

Kyiv, , Ukraine

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

Vinnytsia, , Ukraine

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

Vinnytsia, , Ukraine

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

Vinnytsia, , Ukraine

Countries

Georgia; Moldova; Poland; Ukraine

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2020-000659-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GLPG3970-CL-210

Identifier Type: -

Identifier Source: org_study_id