Ulcerative ColitisPhase 2SEA TURTLENCT04577794
A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 6 Weeks in Adults With Ulcerative Colitis
A Phase 2 study testing GLPG3970 in people with Ulcerative Colitis, run by Lakefront Biotherapeutics NV at 15 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- GLPG3970
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 15 sitesin 4 countries
- Study dates
- 5 Oct 2020to 31 May 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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:
- 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
- MCS stool frequency (SF) subscore ≥1; AND
- MCS rectal bleeding (RB) subscore ≥1.
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- 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:
- 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.
- 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.
- 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.
Who cannot join
- 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:
- bloody diarrhea ≥6/day AND
- 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.
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- 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.
Trial locations and contacts
15 sites in 4 countries.
15 sites in 4 countries
Ukraine10 sites
I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital
Dnipro, 49005
Ivano-Frankivsk Regional Clinical Hospital
Ivano-Frankivsk, 76000
CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2
Kharkiv, 61037
CHI Kharkiv City Clinical Hospital #13
Kharkiv, 61124
Communal Nonprofit Enterprise Kherson City Clinical Hospital n.a. Afanasii and Olga Tropini
Kherson, 73000
Medical Center "Harmoniya Krasy"
Kyiv, 01135
Med Center 'Ok!Clinic+' of International Institute of Clinical Trials LLC
Kyiv, 02091
M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU
Vinnytsia, 21018
CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM
Vinnytsia, 21029
SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU
Vinnytsia, 21029
Poland3 sites
Centrum Medyczne PROMED
Krakow, 31-513
Endoskopia Sp. z o.o.
Sopot, 81-756
ETG Zamosc
Zamość, 22-400
About this study
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
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.
- Conditions
- Ulcerative Colitis
- Being tested
- GLPG3970, Placebo
- Keywords
- Colitis, Ulcer, Moderately active ulcerative colitis, Chronic inflammatory bowel disease, Inflammatory Bowel Diseases, Digestive System Diseases
- Medical subject headings
- Colitis, Ulcerative, Colitis, Ulcer, Inflammatory Bowel Diseases, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLPG3970Drug
GLPG3970 powder and solvent for oral solution reconstituted prior to use.
PlaceboDrug
Placebo powder and solvent for oral solution reconstituted prior to use.
| Study group | Role | What they receive |
|---|---|---|
| GLPG3970 | Experimental | Participants received 400 milligrams (mg) GLPG3970 oral solution, once daily (QD) for a period of 6 weeks. Receives: Drug: GLPG3970 |
| Placebo | Placebo comparator | Participants received GLPG3970 matching placebo oral solution, QD for a period of 6 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 6
Secondary outcomes (2)
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.
Measured: 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.
Measured: Day 15: pre-dose; Day 29: pre-dose; Day 43: pre-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start5 Oct 2020
- Primary completion17 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakefront Biotherapeutics NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Galapagos Medical Director, Study director, Lakefront Biotherapeutics NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04577794
- Sponsor's protocol ID
- GLPG3970-CL-210
- Other IDs
- 2020-000659-11
- Acronym
- SEA TURTLE
- Status last verified
- Apr 2022
- First submitted
- 30 Sep 2020
- Last updated
- 27 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Giorio L, De Vos S, Colli ML, Merciris D, Vissers E, Innocenti T, Kolb F, Ferrante M, Sabino JG, Vermeire S, Arnauts K, Verstockt B. Bridging preclinical and clinical efficacy of SIK2/SIK3 inhibition in inflammatory bowel disease through integrated murine, patient-derived models, and phase 2a trial-based analyses. J Crohns Colitis. 2026 Sep 3;20(9):jjag133. doi: 10.1093/ecco-jcc/jjag133.
PubMed 42728025
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04577794
- Acronym / sponsor ID
- SEA TURTLE / GLPG3970-CL-210
- Conditions
- Ulcerative Colitis
- Keywords
- Colitis, Ulcer, Moderately active ulcerative colitis, Chronic inflammatory bowel disease, Inflammatory Bowel Diseases, Digestive System Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 17 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 8 Oct 2020 (actual)
- Results
- Posted 27 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GLPG3970 | Experimental | Drug: GLPG3970Participants received 400 milligrams (mg) GLPG3970 oral solution, once daily (QD) for a period of 6 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received GLPG3970 matching placebo oral solution, QD for a period of 6 weeks. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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 (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLPG3970GLPG3970 powder and solvent for oral solution reconstituted prior to use. | Drug | GLPG3970 |
| PlaceboPlacebo powder and solvent for oral solution reconstituted prior to use. | Drug | Placebo |
Primary outcome
Change From Baseline in Total MCS at Week 6
Time frame: Baseline and 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.
2 secondary outcomes
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
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
Time frame: Day 15: pre-dose; Day 29: pre-dose; Day 43: pre-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42728025Giorio L, De Vos S, Colli ML, Merciris D, Vissers E, Innocenti T, Kolb F, Ferrante M, Sabino JG, Vermeire S, Arnauts K, Verstockt B. Bridging preclinical and clinical efficacy of SIK2/SIK3 inhibition in inflammatory bowel disease through integrated murine, patient-derived models, and phase 2a trial-based analyses. J Crohns Colitis. 2026 Sep 3;20(9):jjag133. doi: 10.1093/ecco-jcc/jjag133.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Galapagos Medical Director study director
Lakefront Biotherapeutics NV
15 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GLPG3970 in people with Ulcerative Colitis, run by Lakefront Biotherapeutics NV at 15 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Ukraine, Poland, Georgia, Moldova. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Total MCS at Week 6 (time frame: Baseline and Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04577794, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2023; AzTrials last refreshed its copy on 2 Nov 2026.