A Phase 2 interventional study of GLPG3970 and Placebo in Ulcerative Colitis, sponsored by Galapagos NV. Completed at 15 sites in 4 countries. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2023-01-27.
Sponsored by Galapagos NV · Phase 2, Interventional, and Treatment
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.
1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.
This study's enrollment of 31 is below the median of 60 across 771 interventional studies indexed under Colitis.
Browse Colitis studies →Galapagos NV is the lead sponsor of 103 studies on the registry; none are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 11 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
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:
Exhibit acute severe UC per the following criteria:
Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
Participants received 400 milligrams (mg) GLPG3970 oral solution, once daily (QD) for a period of 6 weeks.
Drug: GLPG3970
Participants received GLPG3970 matching placebo oral solution, QD for a period of 6 weeks.
Drug: Placebo
GLPG3970 powder and solvent for oral solution reconstituted prior to use.
Placebo powder and solvent for oral solution reconstituted prior to use.
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.
Time frame: Baseline and Week 6
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.
Time frame: 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.
Time frame: Day 15: pre-dose; Day 29: pre-dose; Day 43: pre-dose
Study was conducted across 4 countries (Georgia, the Republic of Moldova, Poland, and Ukraine).
| Milestone | GLPG3970 | Placebo |
|---|---|---|
| Started | 21 | 10 |
| Completed | 20 | 9 |
| Not completed | 1 | 1 |
| Withdrew: Adverse event | 1 | 1 |
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.
| units on a scale | GLPG3970 | Placebo |
|---|---|---|
| Change From Baseline in Total MCS at Week 6 | -2.6 ± 0.57 | -2.6 ± 0.85 |
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.
| participants | GLPG3970 | Placebo |
|---|---|---|
| TEAEs | 11 | 3 |
| Serious TEAEs | 0 | 0 |
| TEAEs leading to death | 0 | 0 |
| Treatment-related TEAEs | 4 | 1 |
| TEAEs leading to study drug discontinuation | 1 | 0 |
Ctrough was defined as plasma concentration level at the end of the dosing interval.
| nanograms per milliliter (ng/mL) | GLPG3970 |
|---|---|
| Day 15: Pre-dose | 73.2 ± 145 |
| Day 29: Pre-dose | 55.9 ± 65.3 |
| Day 43: Pre-dose | 84.9 ± 107 |
Collected over First dose date up to 14 days after the last dose of study drug (up to 57 days). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GLPG3970 | 0/21 (0%) | 0/21 (0%) | 11/21 (52.4%) |
| Placebo | 0/10 (0%) | 0/10 (0%) | 3/10 (30%) |
| Event | GLPG3970 | Placebo |
|---|---|---|
| NauseaGastrointestinal disorders | 4/21 | 0/10 |
| Lipase increasedInvestigations | 3/21 | 0/10 |
| Blood bilirubin increasedInvestigations | 0/21 | 1/10 |
| Neutrophil count decreasedInvestigations | 0/21 | 1/10 |
| Back painMusculoskeletal and connective tissue disorders | 0/21 | 1/10 |
| AnaemiaBlood and lymphatic system disorders | 0/21 | 1/10 |
| HaematocheziaGastrointestinal disorders | 2/21 | 0/10 |
| Amylase increasedInvestigations | 2/21 | 0/10 |
| Abdominal painGastrointestinal disorders | 1/21 | 0/10 |
| Abdominal pain upperGastrointestinal disorders | 1/21 | 0/10 |
Safety analysis set consisted of all participants who received at least 1 dose of investigational product (IP).
| Age, Continuous(years) | GLPG3970 | Placebo | Total |
|---|---|---|---|
| Mean | 39.7 ± 10.9 | 37.8 ± 5.8 | 39.1 ± 9.5 |
| Sex: Female, Male(Participants) | GLPG3970 | Placebo | Total |
|---|---|---|---|
| Female | 5 | 1 | 6 |
| Male | 16 | 9 | 25 |
| Ethnicity (NIH/OMB)(Participants) | GLPG3970 | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 21 | 10 | 31 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | GLPG3970 | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 21 | 10 | 31 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Total Mayo Clinical Score (MCS)(units on a scale) | GLPG3970 | Placebo | Total |
|---|---|---|---|
| Mean | 8.5 ± 1.2 | 8.2 ± 1.3 | 8.4 ± 1.2 |
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Galapagos NV