Trial Outcomes & Findings for A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 6 Weeks in Adults With Ulcerative Colitis (NCT NCT04577794)

Last Updated: 2023-01-27

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

31 participants

Primary outcome timeframe

Baseline and Week 6

Results posted on

2023-01-27

Participant Flow

Study was conducted across 4 countries (Georgia, the Republic of Moldova, Poland, and Ukraine).

A total of 65 participants were screened, out of which 31 were randomized and treated.

Participant milestones

Participant milestones
Measure	GLPG3970 Participants received 400 milligrams (mg) GLPG3970 oral solution, once daily (QD) for a period of 6 weeks.	Placebo Participants received GLPG3970 matching placebo oral solution, QD for a period of 6 weeks.
Overall Study STARTED	21	10
Overall Study COMPLETED	20	9
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	GLPG3970 Participants received 400 milligrams (mg) GLPG3970 oral solution, once daily (QD) for a period of 6 weeks.	Placebo Participants received GLPG3970 matching placebo oral solution, QD for a period of 6 weeks.
Overall Study Adverse Event	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GLPG3970 n=21 Participants Participants received 400 mg GLPG3970 oral solution, QD for a period of 6 weeks.	Placebo n=10 Participants Participants received GLPG3970 matching placebo oral solution, QD for a period of 6 weeks.	Total n=31 Participants Total of all reporting groups
Age, Continuous	39.7 years STANDARD_DEVIATION 10.9 • n=5 Participants	37.8 years STANDARD_DEVIATION 5.8 • n=7 Participants	39.1 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	9 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants	10 Participants n=7 Participants	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants	10 Participants n=7 Participants	31 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Total Mayo Clinical Score (MCS)	8.5 units on a scale STANDARD_DEVIATION 1.2 • n=5 Participants	8.2 units on a scale STANDARD_DEVIATION 1.3 • n=7 Participants	8.4 units on a scale STANDARD_DEVIATION 1.2 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 6

Population: 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.

Outcome measures

Outcome measures
Measure	GLPG3970 n=18 Participants Participants received 400 mg GLPG3970 oral solution, QD for a period of 6 weeks.	Placebo n=9 Participants Participants received GLPG3970 matching placebo oral solution, QD for a period of 6 weeks.
Change From Baseline in Total MCS at Week 6	-2.6 units on a scale Standard Error 0.57	-2.6 units on a scale Standard Error 0.85

SECONDARY outcome

Timeframe: First dose date up to 14 days after the last dose of study drug (up to 57 days)

Population: Participants in the safety analysis set were analyzed.

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.

Outcome measures

Outcome measures
Measure	GLPG3970 n=21 Participants Participants received 400 mg GLPG3970 oral solution, QD for a period of 6 weeks.	Placebo n=10 Participants Participants received GLPG3970 matching placebo oral solution, QD for a period of 6 weeks.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) TEAEs	11 participants	3 participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Serious TEAEs	0 participants	0 participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) TEAEs leading to death	0 participants	0 participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Treatment-related TEAEs	4 participants	1 participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) TEAEs leading to study drug discontinuation	1 participants	0 participants

SECONDARY outcome

Timeframe: Day 15: pre-dose; Day 29: pre-dose; Day 43: pre-dose

Population: 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.

Ctrough was defined as plasma concentration level at the end of the dosing interval.

Outcome measures

Outcome measures
Measure	GLPG3970 n=16 Participants Participants received 400 mg GLPG3970 oral solution, QD for a period of 6 weeks.	Placebo Participants received GLPG3970 matching placebo oral solution, QD for a period of 6 weeks.
Plasma Concentration (Ctrough) of GLPG3970 Day 15: Pre-dose	73.2 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 145	—
Plasma Concentration (Ctrough) of GLPG3970 Day 29: Pre-dose	55.9 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 65.3	—
Plasma Concentration (Ctrough) of GLPG3970 Day 43: Pre-dose	84.9 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 107	—

Adverse Events

GLPG3970

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Galapagos Medical Information

Galapagos NV

Phone: +32 15 342 900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Measure	GLPG3970 n=21 participants at risk Participants received 400 mg GLPG3970 oral solution, QD for a period of 6 weeks.	Placebo n=10 participants at risk Participants received GLPG3970 matching placebo oral solution, QD for a period of 6 weeks.
Gastrointestinal disorders Nausea	19.0% 4/21 • Number of events 4 • 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.	0.00% 0/10 • 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.
Gastrointestinal disorders Haematochezia	9.5% 2/21 • Number of events 2 • 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.	0.00% 0/10 • 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.
Gastrointestinal disorders Abdominal pain	4.8% 1/21 • Number of events 1 • 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.	0.00% 0/10 • 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.
Gastrointestinal disorders Abdominal pain upper	4.8% 1/21 • Number of events 1 • 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.	0.00% 0/10 • 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.
Gastrointestinal disorders Flatulence	4.8% 1/21 • Number of events 1 • 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.	0.00% 0/10 • 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.
Gastrointestinal disorders Frequent bowel movements	4.8% 1/21 • Number of events 1 • 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.	0.00% 0/10 • 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.
Gastrointestinal disorders Stomatitis	4.8% 1/21 • Number of events 1 • 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.	0.00% 0/10 • 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.
Investigations Lipase increased	14.3% 3/21 • Number of events 4 • 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.	0.00% 0/10 • 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.
Investigations Amylase increased	9.5% 2/21 • Number of events 2 • 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.	0.00% 0/10 • 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.
Investigations Blood lactate dehydrogenase decreased	4.8% 1/21 • Number of events 1 • 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.	0.00% 0/10 • 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.
Investigations Lymphocyte count decreased	4.8% 1/21 • Number of events 1 • 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.	0.00% 0/10 • 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.
Investigations SARS-CoV-2 test positive	4.8% 1/21 • Number of events 1 • 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.	0.00% 0/10 • 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.
Investigations Blood bilirubin increased	0.00% 0/21 • 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.	10.0% 1/10 • Number of events 1 • 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.
Investigations Neutrophil count decreased	0.00% 0/21 • 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.	10.0% 1/10 • Number of events 1 • 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.
General disorders Pain	4.8% 1/21 • Number of events 1 • 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.	0.00% 0/10 • 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.
General disorders Pyrexia	4.8% 1/21 • Number of events 1 • 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.	0.00% 0/10 • 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.
Skin and subcutaneous tissue disorders Erythema	4.8% 1/21 • Number of events 1 • 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.	0.00% 0/10 • 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.
Skin and subcutaneous tissue disorders Rash	4.8% 1/21 • Number of events 1 • 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.	0.00% 0/10 • 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.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	4.8% 1/21 • Number of events 1 • 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.	0.00% 0/10 • 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.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/21 • 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.	10.0% 1/10 • Number of events 1 • 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.
Metabolism and nutrition disorders Hyperkalaemia	4.8% 1/21 • Number of events 1 • 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.	0.00% 0/10 • 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.
Renal and urinary disorders Nephrolithiasis	4.8% 1/21 • Number of events 1 • 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.	0.00% 0/10 • 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.
Reproductive system and breast disorders Pelvic cyst	4.8% 1/21 • Number of events 1 • 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.	0.00% 0/10 • 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.
Blood and lymphatic system disorders Anaemia	0.00% 0/21 • 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.	10.0% 1/10 • Number of events 1 • 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.