Crohn DiseasePhase 2APOLLO-CDNCT05013905

A Phase 2a Safety and Efficacy Open-Label Study of Tulisokibart (MK-7240/PRA023) in Participants With Moderately to Severely Active Crohn's Disease (MK-7240-006)

A Phase 2 study testing Tulisokibart and Companion Diagnostic (CDx) in people with Crohn Disease, run by Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 37 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to assess the safety and efficacy of tulisokibart (MK-7240) in participants with moderately to severely active Crohn's Disease. After the completion of the 12-week Induction Period, eligible participants have the option to enter an Open-label Extension (OLE) Period for up to 170 weeks. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Crohn Disease
What is being tested?: Tulisokibart and Companion Diagnostic (CDx)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 55 participants
Where: 37 sitesin 8 countries
Study dates: 28 Jul 2021to 27 May 2025
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Confirmed diagnosis of Crohn's disease (CD)
Moderately to severely active CD as defined by Crohn's disease activity index (CDAI) score and centrally read endoscopy
Must have corticosteroid dependence or have had no response, insufficient response, loss of response and/or intolerance to at least one of the following therapies: corticosteroid, immunosuppressants, or an approved anti-tumor necrosis factor (TNF), anti-integrin, or anti-interleukin (IL)12/23
Able to provide written informed consent and understand and comply with the requirements of the study

Who cannot join

Women of child bearing potential (WOCBP) and men with female partner of childbearing potential who are unwilling to use two highly effective methods of contraception to avoid pregnancy for the entire study period and up to 12 weeks after the last dose of study drug
Diagnosis of ulcerative colitis (UC) or indeterminate colitis
CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or illeal involvement
Suspected or diagnosed intra-abdominal or perianal abscess at screening
Current stoma or need for colostomy or ileostomy
Previous small bowel resection with a combined resected length of >100 cm or previous colonic resection of > 2 segments

Show all 10Show fewer

Surgical bowel resection within 3 months before screening
Past or current evidence of definite low-grade or high-grade colonic dysplasia not completely removed
Participants in the opinion of the investigator are at an unacceptable risk for participation in the study
Participants who meet the protocol criteria for important laboratory exclusion criteria

Trial locations and contacts

37 sites in 8 countries.

Country

City, postcode or hospital

37 sites in 8 countries

United States16 sites

Prometheus Biosciences Selected Site
Bellevue, Washington, 98004
Prometheus Biosciences Selected Site
Chesterfield, Michigan, 48047
Prometheus Biosciences Selected Site
Garland, Texas, 75044
Prometheus Biosciences Selected Site
Lebanon, New Hampshire, 03756
Prometheus Biosciences Selected Site
Liberty, Kansas, 64098
Prometheus Biosciences Selected Site
Los Angeles, California, 90045
Prometheus Biosciences Selected Site
Los Angeles, California, 90048
Prometheus Biosciences Selected Site
Lubbock, Texas, 79410
Prometheus Biosciences Selected Site
Lubbock, Texas, 79424
Prometheus Biosciences Selected Site
New York, New York, 10065
Prometheus Biosciences Selected Site
San Antonio, Texas, 78229
Prometheus Biosciences Selected Site
Southlake, Texas, 78229
Prometheus Biosciences Selected Site
St Louis, Missouri, 63141
Prometheus Biosciences Selected Site
Tacoma, Washington, 98405
Prometheus Biosciences Selected Site
Tyler, Texas, 75702
Prometheus Biosciences Selected Site
Ypsilanti, Michigan, 48197

Other trials in United States

Poland8 sites

Prometheus Biosciences Selected Center
Krakow, 31-501
Prometheus Biosciences Selected Site
Rzeszów, 35-326
Prometheus Biosciences Selected Site
Sopot, 81-756
Prometheus Biosciences Selected Site
Torun, 87-100
Prometheus Biosciences Selected Center
Warsaw, 00-635
Prometheus Biosciences Selected Site
Warsaw, 03-580
Prometheus Biosciences Selected Center
Warsaw, 52-416
Prometheus Biosciences Selected Site
Wroclaw, 52-416

Other trials in Poland

France4 sites

Prometheus Biosciences Selected Site
Clichy, 92110
Prometheus Biosciences Selected Site
Nice, 06202
Prometheus Biosciences Selected Site
Saint-Priest-en-Jarez, 42270
Prometheus Biosciences Selected Site
Vandœuvre-lès-Nancy, 54511

Other trials in France

Australia3 sites

Prometheus Biosciences Selected Site
Adelaide, South Australia, 5000
Prometheus Biosciences Selected Site
Bankstown, New South Wales, 2146
Prometheus Biosciences Selected Site
Woolloongabba, Queensland, 4102

Other trials in Australia

Belgium2 sites

Prometheus Biosciences Selected Site
Leuven, 3000
Prometheus Biosciences Selected Site
Liège, 4000

Other trials in Belgium

Czechia2 sites

Prometheus Biosciences Selected Site
Brno
Prometheus Biosciences Selected Site
Slaný, 274 01

Other trials in Czechia

Canada1 site

Prometheus Biosciences Selected Site
London, Ontario, N6A 5W9

Other trials in Canada

Georgia1 site

Prometheus Biosciences Selected Site
Tbilisi

Other trials in Georgia

About this study

Official title: A Phase 2a, Multi-Center, Open-Label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of PRA023 in Subjects With Moderately to Severely Active Crohn's Disease

The purpose of this study is to assess the safety and efficacy of tulisokibart (MK-7240) in participants with moderately to severely active Crohn's Disease.

After the completion of the 12-week Induction Period, eligible participants have the option to enter an Open-label Extension (OLE) Period for up to 170 weeks.

Conditions: Crohn Disease
Being tested: Tulisokibart, Companion Diagnostic (CDx)
Keywords: APOLLO-CD, APOLLO, Crohn's Disease
Medical subject headings: Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TulisokibartBiological
Also called PRA023, MK-7240
Tulisokibart administered by IV infusion as directed by the protocol
Companion Diagnostic (CDx)Diagnostic test
PRA023 CDx Genotyping Assay

Study groups in NCT05013905
Study group	Role	What they receive
Induction Tulisokibart	Experimental	During the 12-week Induction Period, participants receive tulisokibart administered by intravenous (IV) infusion at 1000 mg at Week 0 and 500 mg at Weeks 2, 6, and 10. Receives: Biological: Tulisokibart; Diagnostic Test: Companion Diagnostic (CDx)
OLE Tulisokibart 100 mg	Experimental	After completing the 12-week Induction Period, eligible participants have the option to enter the OLE Period for up to 170 weeks. Participants are randomized into the OLE Period to receive 100 mg tulisokibart by IV infusion every 4 weeks (q4w). At the discretion of the investigator, participants may titrate up to 250 mg Q4W if disease activity is not adequately controlled. Receives: Biological: Tulisokibart
OLE Tulisokibart 250 mg	Experimental	After completing the 12-week Induction Period, eligible participants have the option to enter the OLE Period for up to 170 weeks. Participants are randomized into the OLE Period to receive 250 mg tulisokibart by IV infusion q4w. Receives: Biological: Tulisokibart

What is being measured

The primary outcome is the main question the study is designed to answer.

Adverse Events
Number of participants who experienced treatment-emergent adverse events (AEs)
Measured: Up to approximately 18 weeks
Serious Adverse Events
Number of participants who experienced serious adverse events (SAEs)
Measured: Up to approximately 18 weeks
Adverse Events Leading to Discontinuation
Number of participants who experienced AEs leading to discontinuation
Measured: Up to approximately 12 weeks
Endoscopic Improvement
Number of participants achieving induction of endoscopic improvement (decrease in simple endoscopy score for Crohn's disease [SES-CD] ≥ 50% from Baseline)
Measured: Week 12

Secondary outcomes (11)

Clinical Remission
Number of participants achieving clinical remission, as defined by Crohn's disease activity index [CDAI] score < 150
Measured: Week 12
Endoscopic and Clinical Improvement
Number of participants who achieved a decrease in SES-CD ≥ 50% AND reduction in CDAI ≥ 100 points from Baseline or CDAI<150
Measured: Week 12
Number of Participants Achieving Biomarker and Clinical Composite Improvement
Biomarker and clinical composite improvement is defined as a decrease by at least 50% in hsCRP or fecal calprotectin from baseline and a reduction of either CDAI ≥ 100 points from Baseline or CDAI<150 in subjects with at least one elevated biomarker at baseline.
Measured: Week 12
Normalization of C-reactive Protein
Number of participants with normalization of hsCRP (as defined by hsCRP < 5 mg/L), among subjects with elevated concentrations at Baseline, at Week 12
Measured: Week 12
Normalization of Fecal Calprotectin
Number of participants with normalization of fecal calprotectin (fecal calprotectin < 250 ug/g), among subjects with elevated concentrations at Baseline, at Week 12
Measured: Week 12
Clinical Response
Clinical response is defined as either a reduction of either CDAI ≥ 100 points from Baseline or CDAI<150.
Measured: Week 12
Two Component Patient-reported Outcome (PRO-2) Remission
Number of subjects with PRO-2 remission (defined as average daily abdominal pain score ≤ 1 point and average daily stool frequency ≤ 3 points with abdominal pain and stool frequency no worse than Baseline) at Week 12.
Measured: Week 12
Change From Baseline in Simple Endoscopy Score for Crohn's Disease (SES-CD)
Assessment of change in simple endoscopy score for Crohn's Disease (SES-CD) from Baseline. Measure Description: The SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing, each on a scale from 0 (none) to 3 in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.
Measured: Baseline and Week 12
Serum Concentration of Tulisokibart
Blood samples were obtained for PK analysis of the serum concentration of tulisokibart at week 12.
Measured: Week 12
Number of Participants Positive for Anti-drug Antibody (ADA)
Blood samples were collected for the determination of anti-tulisokibart antibodies based on confirmatory assay. The number of participants with confirmed positive anti-tulisokibart antibodies results at any visit during the study is presented.
Measured: Up to approximately 12 weeks
Number of Participants With Positive Neutralizing Anti-Bodies (NAB)
Blood samples were collected for the determination of NAB. The number of participants with positive NAB results at any visit during the study is presented.
Measured: Up to approximately 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Jul 202127 May 2025

First posted19 Aug 2021
Study start28 Jul 2021
Primary completion23 Sep 2022
Study completion27 May 2025

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 Crohn DiseaseStudies 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
Model description: Participants enrolling in the study are initially allocated to a single treatment arm in the Induction Period. Eligible participants who complete the Induction Period and responded to tulisokibart treatment may then enter the optional 170-week OLE Period. Participants who enter the OLE Period are randomized to one of two tulisokibart treatment arms.
Masking: None (open label)
Enrolment: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05013905
Sponsor's protocol ID: PR200-103
Other IDs: 7240-006, 2023-509742-35-00, U1111-1309-6108, PR200-103, 2021-000092-37, 2023
Acronym: APOLLO-CD
Status last verified: Jun 2026
First submitted: 13 Aug 2021
Last updated: 22 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: Yes
Individual data sharing: Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

Feagan BG, Sands BE, Siegel CA, Dubinsky MC, Longman RS, Sabino J, Laurent O, Luo A, Lu J, Nguyen DD, Munoz-Elias EJ, Llewellyn H, Wang Y, Jang I, Bilsborough J, Marchelletta R, Towfic F, Yen M, Anderson JK, DuVall A, Kierkus J, Woynarowski M, Al Kharrat H, Targan SR, McGovern DPB. Safety and efficacy of the anti-TL1A monoclonal antibody tulisokibart for Crohn's disease: a phase 2a induction trial. Lancet Gastroenterol Hepatol. 2025 Aug;10(8):715-725. doi: 10.1016/S2468-1253(25)00071-8. Epub 2025 May 30.
PubMed 40456235

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
ALPCO Calprotectin CLIA Assay - Measurement of Calprotectin Levels in Human Stool
Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Inflammatory Bowel Syndrome
RecruitingPhase 3
Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)
Crohn Disease, Colitis, Ulcerative
Active, not recruitingPhase 4
Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RA) and Diet in Inflammatory Bowel Disease (IBD) Patients
Crohn Disease
RecruitingPhase 2
NOV-ERA - A Clinical Trial to Assess the Efficacy and Safety of Ontunisertib Compared to Placebo in Patients With Fibrostenosing Crohn's Disease
Fibrostenotic Crohn's Disease

All Crohn Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2a, Multi-Center, Open-Label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of PRA023 in Subjects With Moderately to Severely Active Crohn's Disease
ClinicalTrials.gov ID: NCT05013905
Acronym / sponsor ID: APOLLO-CD / PR200-103
Conditions: Crohn Disease
Keywords: APOLLO-CD, APOLLO, Crohn's Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
Study start: 28 Jul 2021 (actual)
Primary completion: 23 Sep 2022 (actual)
Study completion: 27 May 2025 (actual)
First posted: 19 Aug 2021 (actual)
Results: Posted 1 Nov 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to assess the safety and efficacy of tulisokibart (MK-7240) in participants with moderately to severely active Crohn's Disease.

After the completion of the 12-week Induction Period, eligible participants have the option to enter an Open-label Extension (OLE) Period for up to 170 weeks.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: Participants enrolling in the study are initially allocated to a single treatment arm in the Induction Period. Eligible participants who complete the Induction Period and responded to tulisokibart treatment may then enter the optional 170-week OLE Period. Participants who enter the OLE Period are randomized to one of two tulisokibart treatment arms.

Arm	Type	Receives
Induction Tulisokibart	Experimental	Biological: Tulisokibart, Diagnostic Test: Companion Diagnostic (CDx)During the 12-week Induction Period, participants receive tulisokibart administered by intravenous (IV) infusion at 1000 mg at Week 0 and 500 mg at Weeks 2, 6, and 10.
OLE Tulisokibart 100 mg	Experimental	Biological: TulisokibartAfter completing the 12-week Induction Period, eligible participants have the option to enter the OLE Period for up to 170 weeks. Participants are randomized into the OLE Period to receive 100 mg tulisokibart by IV infusion every 4 weeks (q4w). At the discretion of the investigator, participants may titrate up to 250 mg Q4W if disease activity is not adequately controlled.
OLE Tulisokibart 250 mg	Experimental	Biological: TulisokibartAfter completing the 12-week Induction Period, eligible participants have the option to enter the OLE Period for up to 170 weeks. Participants are randomized into the OLE Period to receive 250 mg tulisokibart by IV infusion q4w.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Confirmed diagnosis of Crohn's disease (CD)
Moderately to severely active CD as defined by Crohn's disease activity index (CDAI) score and centrally read endoscopy
Must have corticosteroid dependence or have had no response, insufficient response, loss of response and/or intolerance to at least one of the following therapies: corticosteroid, immunosuppressants, or an approved anti-tumor necrosis factor (TNF), anti-integrin, or anti-interleukin (IL)12/23
Able to provide written informed consent and understand and comply with the requirements of the study

Key exclusion criteria (10 listed)

Women of child bearing potential (WOCBP) and men with female partner of childbearing potential who are unwilling to use two highly effective methods of contraception to avoid pregnancy for the entire study period and up to 12 weeks after the last dose of study drug
Diagnosis of ulcerative colitis (UC) or indeterminate colitis
CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or illeal involvement
Suspected or diagnosed intra-abdominal or perianal abscess at screening
Current stoma or need for colostomy or ileostomy

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
TulisokibartAlso: PRA023, MK-7240Tulisokibart administered by IV infusion as directed by the protocol	Biological	Induction Tulisokibart, OLE Tulisokibart 100 mg, OLE Tulisokibart 250 mg
Companion Diagnostic (CDx)PRA023 CDx Genotyping Assay	Diagnostic test	Induction Tulisokibart

Primary outcome

Adverse Events
Time frame: Up to approximately 18 weeks
Number of participants who experienced treatment-emergent adverse events (AEs)
Serious Adverse Events
Time frame: Up to approximately 18 weeks
Number of participants who experienced serious adverse events (SAEs)
Adverse Events Leading to Discontinuation
Time frame: Up to approximately 12 weeks
Number of participants who experienced AEs leading to discontinuation
Endoscopic Improvement
Time frame: Week 12
Number of participants achieving induction of endoscopic improvement (decrease in simple endoscopy score for Crohn's disease [SES-CD] ≥ 50% from Baseline)

11 secondary outcomes

Clinical Remission
Time frame: Week 12
Endoscopic and Clinical Improvement
Time frame: Week 12
Number of Participants Achieving Biomarker and Clinical Composite Improvement
Time frame: Week 12
Normalization of C-reactive Protein
Time frame: Week 12
Normalization of Fecal Calprotectin
Time frame: Week 12
Clinical Response
Time frame: Week 12
Two Component Patient-reported Outcome (PRO-2) Remission
Time frame: Week 12
Change From Baseline in Simple Endoscopy Score for Crohn's Disease (SES-CD)
Time frame: Baseline and Week 12
Serum Concentration of Tulisokibart
Time frame: Week 12
Number of Participants Positive for Anti-drug Antibody (ADA)
Time frame: Up to approximately 12 weeks
Number of Participants With Positive Neutralizing Anti-Bodies (NAB)
Time frame: Up to approximately 12 weeks

Results and safety

Results posted to the registry on 1 Nov 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Induction Tulisokibart	55	49
OLE Tulisokibart 100 mg	0	0
OLE Tulisokibart 250 mg	0	0

Primary outcome: Adverse Events

Time frame: Up to approximately 18 weeks. Count of participants. Unit: Participants

Measure	Induction Tulisokibart n = 55
Value	44

Population analysed: All participants who received at least 1 dose of tulisokibart.

Primary outcome: Serious Adverse Events

Time frame: Up to approximately 18 weeks. Count of participants. Unit: Participants

Measure	Induction Tulisokibart n = 55
Value	9

Population analysed: All participants who received at least 1 dose of tulisokibart.

Primary outcome: Adverse Events Leading to Discontinuation

Time frame: Up to approximately 12 weeks. Count of participants. Unit: Participants

Measure	Induction Tulisokibart n = 55
Value	2

Population analysed: All participants who received at least 1 dose of tulisokibart.

Primary outcome: Endoscopic Improvement

Time frame: Week 12. Count of participants. Unit: Participants

Measure	Induction Tulisokibart n = 50
Value	13

Population analysed: All participants who have been treated with tulisokibart with Baseline CDAI and SES-CD scores with no important protocol deviations.

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to approximately 43 months (duration over which AEs were assessed at the participant level). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Induction Tulisokibart	9 of 55 (16.4%)	33 of 55 (60%)	0 of 55
Induction Tulisokibart → OLE Tulisokibart 100 mg	4 of 19 (21.1%)	17 of 19 (89.5%)	0 of 19
Induction Tulisokibart → OLE Tulisokibart 250 mg	4 of 18 (22.2%)	16 of 18 (88.9%)	0 of 18

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40456235Feagan BG, Sands BE, Siegel CA, Dubinsky MC, Longman RS, Sabino J, Laurent O, Luo A, Lu J, Nguyen DD, Munoz-Elias EJ, Llewellyn H, Wang Y, Jang I, Bilsborough J, Marchelletta R, Towfic F, Yen M, Anderson JK, DuVall A, Kierkus J, Woynarowski M, Al Kharrat H, Targan SR, McGovern DPB. Safety and efficacy of the anti-TL1A monoclonal antibody tulisokibart for Crohn's disease: a phase 2a induction trial. Lancet Gastroenterol Hepatol. 2025 Aug;10(8):715-725. doi: 10.1016/S2468-1253(25)00071-8. Epub 2025 May 30.
Merck Clinical Trials InformationLink provided by the sponsor.
Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Related trials for Crohn Disease

RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
ALPCO Calprotectin CLIA Assay - Measurement of Calprotectin Levels in Human Stool
Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Inflammatory Bowel Syndrome
RecruitingPhase 3
Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)
Crohn Disease, Colitis, Ulcerative
Active, not recruitingPhase 4
Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RA) and Diet in Inflammatory Bowel Disease (IBD) Patients
Crohn Disease
RecruitingPhase 2
NOV-ERA - A Clinical Trial to Assess the Efficacy and Safety of Ontunisertib Compared to Placebo in Patients With Fibrostenosing Crohn's Disease
Fibrostenotic Crohn's Disease

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.

Medical Director study director

Merck Sharp & Dohme LLC

37 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 10 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 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States, Poland, France, Australia, Belgium and 3 more countries. 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. 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 1 Nov 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?

Adverse Events (time frame: Up to approximately 18 weeks). The study lists 4 primary outcomes in all. 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 NCT05013905, 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 22 Jul 2026.