Ulcerative Colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856
Conditions
Interventions
Product Name: GLPG3970
Product Code: G1567970
Pharmaceutical Form: Powder and solvent for oral solution
INN or Proposed INN: Not applicable
Current Sponsor code: G1567970
Other descriptive name: GLPG3
Sponsors
Galapagos NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject must be able and willing to comply with the clinical study protocol requirements and must sign and date the informed consent form (ICF) as approved by the Independent Ethics Committee (IEC) / Institutional Review Board (IRB), prior to any screening evaluations. 2. Subjects must be =18 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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: a. bloody diarrhea =6/day AND b. 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 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, Campylobacer spp or Yersinia spp. 6. Subject testing positive at screening for SARS-CoV-2 infection as detected by real time polymerase chain reaction (RT-PCR), subjects 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 subjects 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. This list only contains the key exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): - Change from baseline in total Mayo Clinical Score (MCS) at Week 6.;Timepoint(s) of evaluation of this end point: At baseline and at Week 6;Main Objective: To evaluate the effect of GLPG3970 compared to placebo on the signs and symptoms of Ulcerative Colitis (UC) in subjects with moderately to severely active UC.;Secondary Objective: - To evaluate the safety and tolerability of GLPG3970 compared to placebo in subjects with moderately to severely active UC. - To characterize the pharmacokinetics (PK) of GLPG3970 in subjects with moderately to severely active UC. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Number, incidence, and severity of treatment-emergent adverse events. - Observed GLPG3970 plasma trough concentrations (Ctrough).;Timepoint(s) of evaluation of this end point: Various timepoints during the trial as per clinical study design. | — |
Countries
Georgia, Moldova, Republic of, Poland, Ukraine
Contacts
Public ContactClinical trial information desk
Galapagos NV
Outcome results
None listed