CClinicalTrials.gg
CompletedNCT04577794SEA TURTLEUpdated Jan 27, 2023Results posted

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

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

Phase
Phase 2
Study type
Interventional
Enrollment
31
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Ulcerative Colitis

Keywords

  • Colitis
  • Ulcer
  • Moderately active ulcerative colitis
  • Chronic inflammatory bowel disease
  • Inflammatory Bowel Diseases
  • Digestive System Diseases
03

In context

Colitis

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    GLPG3970

    Participants received 400 milligrams (mg) GLPG3970 oral solution, once daily (QD) for a period of 6 weeks.

    Drug: GLPG3970

  • Placebo comparator
    Placebo

    Participants received GLPG3970 matching placebo oral solution, QD for a period of 6 weeks.

    Drug: Placebo

Interventions

  • DrugGLPG3970

    GLPG3970 powder and solvent for oral solution reconstituted prior to use.

  • DrugPlacebo

    Placebo powder and solvent for oral solution reconstituted prior to use.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. 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

07

Results

Posted Jan 27, 2023

Participant flow

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

Participant flow — Overall Study
MilestoneGLPG3970Placebo
Started2110
Completed209
Not completed11
Withdrew: Adverse event11

Outcome measures

PrimaryChange 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
Reported as:
Least squares mean · units on a scale
Change From Baseline in Total MCS at Week 6
units on a scaleGLPG3970Placebo
Change From Baseline in Total MCS at Week 6-2.6 ± 0.57-2.6 ± 0.85
Statistical analysis
  • GLPG3970 vs Placebo · ANCOVA · p = 0.981 · Least square (ls) mean difference: 0.0 · 90% CI -1.7 to 1.7
SecondaryNumber 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)
Reported as:
Number · participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
participantsGLPG3970Placebo
TEAEs113
Serious TEAEs00
TEAEs leading to death00
Treatment-related TEAEs41
TEAEs leading to study drug discontinuation10
SecondaryPlasma 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
Reported as:
Geometric mean · nanograms per milliliter (ng/mL)
Plasma Concentration (Ctrough) of GLPG3970
nanograms per milliliter (ng/mL)GLPG3970
Day 15: Pre-dose73.2 ± 145
Day 29: Pre-dose55.9 ± 65.3
Day 43: Pre-dose84.9 ± 107

Adverse events

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.

Adverse event summary by group
GroupDeathsSeriousOther
GLPG39700/21 (0%)0/21 (0%)11/21 (52.4%)
Placebo0/10 (0%)0/10 (0%)3/10 (30%)
Most frequent other events
Showing 10 of 24
Most frequent other events
EventGLPG3970Placebo
NauseaGastrointestinal disorders4/210/10
Lipase increasedInvestigations3/210/10
Blood bilirubin increasedInvestigations0/211/10
Neutrophil count decreasedInvestigations0/211/10
Back painMusculoskeletal and connective tissue disorders0/211/10
AnaemiaBlood and lymphatic system disorders0/211/10
HaematocheziaGastrointestinal disorders2/210/10
Amylase increasedInvestigations2/210/10
Abdominal painGastrointestinal disorders1/210/10
Abdominal pain upperGastrointestinal disorders1/210/10

Baseline characteristics

Safety analysis set consisted of all participants who received at least 1 dose of investigational product (IP).

Age, Continuous
Age, Continuous(years)GLPG3970PlaceboTotal
Mean39.7 ± 10.937.8 ± 5.839.1 ± 9.5
Sex: Female, Male
Sex: Female, Male(Participants)GLPG3970PlaceboTotal
Female516
Male16925
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)GLPG3970PlaceboTotal
Hispanic or Latino000
Not Hispanic or Latino211031
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)GLPG3970PlaceboTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American000
White211031
More than one race000
Unknown or Not Reported000
Total Mayo Clinical Score (MCS)
Total Mayo Clinical Score (MCS)(units on a scale)GLPG3970PlaceboTotal
Mean8.5 ± 1.28.2 ± 1.38.4 ± 1.2
08

Study locations

15 sites
  • Arensia Exploratory Medicine LLC
    Tbilisi, 0112, Georgia
  • ARENSIA Exploratory Medicine Phase I Unit
    Chisinau, 2025, Moldova, Republic of
  • Centrum Medyczne PROMED
    Kraków, 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-Frankivs'k, 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
09

References and documents

Study documents

  • Study protocol · Jul 2, 2020
  • Statistical analysis plan · Jun 16, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04577794
Lead sponsor
Galapagos NV
Responsible party
Sponsor
First posted
Oct 8, 2020
Start date
Oct 5, 2020
Primary completion
May 17, 2021
Completion
May 31, 2021
Results posted
Jan 27, 2023
Last update
Jan 27, 2023

Study contacts

Galapagos Medical Director
study director · Galapagos NV

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion