A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 6 Weeks in Adults With Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: GLPG3970; Placebo
Intervention description: GLPG3970 powder and solvent for oral solution reconstituted prior to use.; Placebo powder and solvent for oral solution reconstituted prior to use.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Colitis; Ulcer; Moderately active ulcerative colitis; Chronic inflammatory bowel disease; Inflammatory Bowel Diseases; Digestive System Diseases

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.
    

Eligibility 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 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.

        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 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.

        Note: Other protocol-defined Inclusion/Exclusion criteria may apply.