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

NCT04577794 | Completed Phase 2 Results DMC

• 2 other identifiers: GLPG3970-CL-2102020-000659-11
• Study Type: interventional
• Target: 31
• Locations: 4 countries
• Sites: 15

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

Keywords

Colitis; Ulcer; Moderately active ulcerative colitis; Chronic inflammatory bowel disease; Inflammatory Bowel Diseases; Digestive System Diseases

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Total MCS at Week 6

  The MCS is the primary tool for assessing ulcerative colitis activity. Total MCS is the sum of 4 subscores (i.e., stool frequency, rectal bleeding, endoscopic findings, and a physician's global assessment); each rated on a scale from 0 (normal) to 3 (severe). The total MCS value ranges from 0 to 12, with higher scores indicating more severe disease. Missing data were imputed using Rubin's multiple imputation.

  Baseline and Week 6

Secondary Outcomes (2)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

  First dose date up to 14 days after the last dose of study drug (up to 57 days)

• Plasma Concentration (Ctrough) of GLPG3970

  Day 15: pre-dose; Day 29: pre-dose; Day 43: pre-dose

Study Arms (2)

GLPG3970

EXPERIMENTAL

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

Drug: GLPG3970

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

GLPG3970 DRUG

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

GLPG3970

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.
• Moderately to severely active UC as determined at screening by:
• 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
• MCS stool frequency (SF) subscore ≥1; AND
• MCS rectal bleeding (RB) subscore ≥1.
• 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:
• 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.
• 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.
• 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.

You may not qualify if:

• Diagnosis of Crohn's disease, indeterminate colitis, ischemic colitis, fulminant colitis, or toxic megacolon.
• Prior surgical intervention for UC (e.g. colectomy, partial colectomy, ileostomy or colostomy) or likely requirement for surgery for UC, during the study.
• History or evidence of incompletely resected colonic mucosal dysplasia.
• Exhibit acute severe UC per the following criteria:
• bloody diarrhea ≥6/day AND
• 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.
• Screening stool sample positive for ova and/or parasites, Clostridium difficile toxin, Escherichia coli, Salmonella species (spp), Shigella spp, Campylobacter spp or Yersinia spp.
• 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.

Sponsors & Collaborators

• Galapagos NV: lead

Study Sites (15)

Arensia Exploratory Medicine LLC

Tbilisi, 0112, Georgia

Location

ARENSIA Exploratory Medicine Phase I Unit

Chisinau, 2025, Moldova

Location

Centrum Medyczne PROMED

Krakow, 31-513, Poland

Location

Endoskopia Sp. z o.o.

Sopot, 81-756, Poland

Location

ETG Zamosc

Zamość, 22-400, Poland

Location

I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital

Dnipro, 49005, Ukraine

Location

Ivano-Frankivsk Regional Clinical Hospital

Ivano-Frankivsk, 76000, Ukraine

Location

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

Kharkiv, 61037, Ukraine

Location

CHI Kharkiv City Clinical Hospital #13

Kharkiv, 61124, Ukraine

Location

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

Kherson, 73000, Ukraine

Location

Medical Center "Harmoniya Krasy"

Kyiv, 01135, Ukraine

Location

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

Kyiv, 02091, Ukraine

Location

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

Vinnytsia, 21018, Ukraine

Location

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

Vinnytsia, 21029, Ukraine

Location

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

Vinnytsia, 21029, Ukraine

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Colitis; Ulcer; Inflammatory Bowel Diseases; Digestive System Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Galapagos Medical Information
• Organization: Galapagos NV

medicalinfo@glpg.com

+32 15 342 900

Study Officials

• Galapagos Medical Director

  Galapagos NV

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: October 8, 2020
• Study Start: October 5, 2020
• Primary Completion: May 17, 2021
• Study Completion: May 31, 2021
• Last Updated: January 27, 2023
• Results First Posted: January 27, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

MO (1); PL (3); GE (1); UA (10)