- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04577794
A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 6 Weeks in Adults With Ulcerative Colitis (SEA TURTLE)
A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of GLPG3970, Administered Orally for 6 Weeks in Adult Subjects With Moderately to Severely Active Ulcerative Colitis
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Tbilisi, Georgia, 0112
- Arensia Exploratory Medicine Llc
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Chisinau, Moldova, Republic of, 2025
- ARENSIA Exploratory Medicine Phase I Unit
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Kraków, Poland, 31-513
- Centrum Medyczne Promed
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Sopot, Poland, 81-756
- ENDOSKOPIA Sp. z o.o.
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Zamość, Poland, 22-400
- ETG Zamosc
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Dnipro, Ukraine, 49005
- I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital
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Ivano-Frankivs'k, Ukraine, 76000
- Ivano-Frankivsk Regional Clinical Hospital
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Kharkiv, Ukraine, 61124
- CHI Kharkiv City Clinical Hospital #13
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Kharkiv, Ukraine, 61037
- CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2
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Kherson, Ukraine, 73000
- Communal Nonprofit Enterprise Kherson City Clinical Hospital n.a. Afanasii and Olga Tropini
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Kyiv, Ukraine, 02091
- Med Center 'Ok!Clinic+' of International Institute of Clinical Trials LLC
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Kyiv, Ukraine, 01135
- Medical Center "Harmoniya Krasy"
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Vinnytsia, Ukraine, 21018
- M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU
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Vinnytsia, Ukraine, 21029
- CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM
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Vinnytsia, Ukraine, 21029
- SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Key Inclusion Criteria:
- 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.
Key Exclusion Criteria:
- 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.
Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: GLPG3970
Participants received 400 milligrams (mg) GLPG3970 oral solution, once daily (QD) for a period of 6 weeks.
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GLPG3970 powder and solvent for oral solution reconstituted prior to use.
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Placebo Comparator: Placebo
Participants received GLPG3970 matching placebo oral solution, QD for a period of 6 weeks.
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Placebo powder and solvent for oral solution reconstituted prior to use.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change From Baseline in Total MCS at Week 6
Time Frame: Baseline and Week 6
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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.
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Baseline and Week 6
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time Frame: First dose date up to 14 days after the last dose of study drug (up to 57 days)
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Treatment-Emergent Adverse Events (TEAEs) were defined as
Serious TEAE was defined as a TEAE that
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First dose date up to 14 days after the last dose of study drug (up to 57 days)
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Plasma Concentration (Ctrough) of GLPG3970
Time Frame: Day 15: pre-dose; Day 29: pre-dose; Day 43: pre-dose
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Ctrough was defined as plasma concentration level at the end of the dosing interval.
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Day 15: pre-dose; Day 29: pre-dose; Day 43: pre-dose
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GLPG3970-CL-210
- 2020-000659-11 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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