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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-000659-11 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLPG3970 | Experimental | Participants received 400 milligrams (mg) GLPG3970 oral solution, once daily (QD) for a period of 6 weeks. |
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| Placebo | Placebo Comparator | Participants received GLPG3970 matching placebo oral solution, QD for a period of 6 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLPG3970 | Drug | GLPG3970 powder and solvent for oral solution reconstituted prior to use. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Treatment-Emergent Adverse Events (TEAEs) were defined as
Serious TEAE was defined as a TEAE that
|
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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:
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:
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Galapagos Medical Director | Lakefront Biotherapeutics NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arensia Exploratory Medicine LLC | Tbilisi | 0112 | Georgia | |||
| ARENSIA Exploratory Medicine Phase I Unit |
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A total of 65 participants were screened, out of which 31 were randomized and treated.
Study was conducted across 4 countries (Georgia, the Republic of Moldova, Poland, and Ukraine).
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| ID | Title | Description |
|---|---|---|
| FG000 | GLPG3970 | Participants received 400 milligrams (mg) GLPG3970 oral solution, once daily (QD) for a period of 6 weeks. |
| FG001 | Placebo | Participants received GLPG3970 matching placebo oral solution, QD for a period of 6 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 2, 2020 | Apr 26, 2022 |
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| Placebo |
| Drug |
Placebo powder and solvent for oral solution reconstituted prior to use. |
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| First dose date up to 14 days after the last dose of study drug (up to 57 days) |
| 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 |
| Chisinau |
| 2025 |
| Moldova |
| Centrum Medyczne PROMED | Krakow | 31-513 | Poland |
| Endoskopia Sp. z o.o. | Sopot | 81-756 | Poland |
| ETG Zamosc | Zamość | 22-400 | Poland |
| I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital | Dnipro | 49005 | Ukraine |
| Ivano-Frankivsk Regional Clinical Hospital | Ivano-Frankivsk | 76000 | Ukraine |
| CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 | Kharkiv | 61037 | Ukraine |
| CHI Kharkiv City Clinical Hospital #13 | Kharkiv | 61124 | Ukraine |
| Communal Nonprofit Enterprise Kherson City Clinical Hospital n.a. Afanasii and Olga Tropini | Kherson | 73000 | Ukraine |
| Medical Center "Harmoniya Krasy" | Kyiv | 01135 | Ukraine |
| Med Center 'Ok!Clinic+' of International Institute of Clinical Trials LLC | Kyiv | 02091 | Ukraine |
| M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU | Vinnytsia | 21018 | Ukraine |
| CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM | Vinnytsia | 21029 | Ukraine |
| SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU | Vinnytsia | 21029 | Ukraine |
| COMPLETED |
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| NOT COMPLETED |
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Safety analysis set consisted of all participants who received at least 1 dose of investigational product (IP).
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| ID | Title | Description |
|---|---|---|
| BG000 | GLPG3970 | Participants received 400 mg GLPG3970 oral solution, QD for a period of 6 weeks. |
| BG001 | Placebo | Participants received GLPG3970 matching placebo oral solution, QD for a period of 6 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Total Mayo Clinical Score (MCS) | 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. | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Full analysis set consisted of all randomized participants who received at least 1 dose of IP. Participants with available data at specified timepoint were included. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Week 6 |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Treatment-Emergent Adverse Events (TEAEs) were defined as
Serious TEAE was defined as a TEAE that
| Participants in the safety analysis set were analyzed. | Posted | Number | participants | No | First dose date up to 14 days after the last dose of study drug (up to 57 days) |
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| Secondary | Plasma Concentration (Ctrough) of GLPG3970 | Ctrough was defined as plasma concentration level at the end of the dosing interval. | Pharmacokinetic analysis set consisted of all participants who received at least 1 dose of IP with available plasma concentration data. Participants with available plasma concentration at specified time point were included. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Day 15: pre-dose; Day 29: pre-dose; Day 43: pre-dose |
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First dose date up to 14 days after the last dose of study drug (up to 57 days)
Participants in the safety analysis set were analyzed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GLPG3970 | Participants received 400 mg GLPG3970 oral solution, QD for a period of 6 weeks. | 0 | 21 | 0 | 21 | 11 | 21 |
| EG001 | Placebo | Participants received GLPG3970 matching placebo oral solution, QD for a period of 6 weeks. | 0 | 10 | 0 | 10 | 3 | 10 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Haematochezia | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Frequent bowel movements | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Lipase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
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| Amylase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
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| Blood lactate dehydrogenase decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
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| SARS-CoV-2 test positive | Investigations | MedDRA 23.0 | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA 23.0 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
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| Pelvic cyst | Reproductive system and breast disorders | MedDRA 23.0 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
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The sponsor must review and approve any results of the study or abstracts for professional meetings prepared by the investigator(s). Published data must not compromise the objectives of the study. Data from individual study centers in multicenter studies must not be published separately.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Galapagos Medical Information | Galapagos NV | +32 15 342 900 | medicalinfo@glpg.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 16, 2021 | Apr 26, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D003092 | Colitis |
| D014456 | Ulcer |
| D015212 | Inflammatory Bowel Diseases |
| D004066 | Digestive System Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Units | Counts |
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| Participants |
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