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

Ulcerative Colitis Clinical Trial

— SEA TURTLE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04577794
• Other study ID #: GLPG3970-CL-210
• Secondary ID: 2020-000659-11
• Status: Completed
• Phase: Phase 2
• Start date: October 5, 2020
• Est. completion date: May 31, 2021

Study information

• Verified date: April 2022
• Source: Galapagos NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: May 31, 2021
• Est. primary completion date: May 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• GLPG3970
GLPG3970 powder and solvent for oral solution reconstituted prior to use.
• Placebo
Placebo powder and solvent for oral solution reconstituted prior to use.

Locations

Country	Name	City	State
Georgia	Arensia Exploratory Medicine LLC	Tbilisi
Moldova, Republic of	ARENSIA Exploratory Medicine Phase I Unit	Chisinau
Poland	Centrum Medyczne PROMED	Kraków
Poland	Endoskopia Sp. z o.o.	Sopot
Poland	ETG Zamosc	Zamosc
Ukraine	I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital	Dnipro
Ukraine	Ivano-Frankivsk Regional Clinical Hospital	Ivano-Frankivs'k
Ukraine	CHI Kharkiv City Clinical Hospital #13	Kharkiv
Ukraine	CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2	Kharkiv
Ukraine	Communal Nonprofit Enterprise Kherson City Clinical Hospital n.a. Afanasii and Olga Tropini	Kherson
Ukraine	Med Center 'Ok!Clinic+' of International Institute of Clinical Trials LLC	Kyiv
Ukraine	Medical Center "Harmoniya Krasy"	Kyiv
Ukraine	CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM	Vinnytsia
Ukraine	M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU	Vinnytsia
Ukraine	SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU	Vinnytsia

Sponsors (1)

Lead Sponsor	Collaborator
Galapagos NV

Countries where clinical trial is conducted

Georgia,  Moldova, Republic of,  Poland,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Treatment-Emergent Adverse Events (TEAEs) were defined as; Any adverse event (AE) with an onset date on or after the IP start date and no later than 14 days after last dose of IP, or worsening of any AE on or after the IP start date.; Improvement or no change of any ongoing AEs on or after the IP start date are not considered treatment-emergent. If an AE was ongoing at the time of first IP intake and if there was no change or an improvement in its toxicity grade or its seriousness status, this AE was not considered as treatment-emergent.; Serious TEAE was defined as a TEAE that; Resulted in death and was life-threatening; Required in-patient hospitalization or prolongation of existing hospitalization; Resulted in persistent or significant disability/incapacity; Was a congenital anomaly / birth defect; Was medically significant.	First dose date up to 14 days after the last dose of study drug (up to 57 days)
Secondary	Plasma Concentration (Ctrough) of GLPG3970	Ctrough was defined as plasma concentration level at the end of the dosing interval.	Day 15: pre-dose; Day 29: pre-dose; Day 43: pre-dose