Phase 3 study for people with Crohn's Disease and Colitis

Recruiting Phase 3

Sources: ClinicalTrials.gov Checked: 15 October 2026 Not medical advice

This trial at a glance

Status Recruiting

Phase Phase 3

Sponsor Merck Sharp & Dohme LLC

Registry number NCT06430801

Started 5 June 2024 Today 16 October 2026 Estimated completion 30 October 2028

Where this trial is running

Trial sites and the status recorded for each
Site	City	State or country	Status at this site
Concord Repatriation General Hospital-Gastroenterology and Liver Services ( Site 3202)	Concord	NSW	Recruiting
Royal Brisbane and Women's Hospital ( Site 3200)	Brisbane	QLD	Recruiting
Mater Misericordiae Limited ( Site 3209)	Brisbane	QLD	Recruiting
Royal Adelaide Hosp - GI Clinical Trials ( Site 3203)	Adelaide	SA	Recruiting
Monash Health-Gastroenterology ( Site 3206)	Clayton	VIC	Recruiting
The Alfred Hospital-Gastroenterology ( Site 3201)	Melbourne	VIC	Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 15 October 2026 · not medical advice

Who can join

Age 16 Years to 80 Years

Sex Anyone, regardless of sex

Healthy volunteers Not accepted

Enrolment target 1200

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

* Has had a diagnosis of Crohn's disease (CD) at least 3 months before study.

* Has moderately to severely active CD.

* Demonstrated inadequate response, loss of response, or intolerance to one or more of the following categories of drugs: oral locally acting steroids, systemic steroids, immunomodulators, biologic and/or small molecule advanced therapies.

* Adolescent participants ≥16 and \<18 years of age can participate if approved by the country or regulatory/health authority.

Exclusion Criteria:

* Has diagnosis of ulcerative colitis (UC) or indeterminate colitis.

* Has CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement.

* Currently has any of the following complications of CD: suspected or diagnosed with intra-abdominal or perianal abscess, known symptomatic stricture or colonic stenosis not passable in endoscopy, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.

* Has current stoma or need for colostomy or ileostomy.

* Is missing \>2 segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.

* Has been diagnosed with short gut or short bowel syndrome, or any other uncontrolled chronic diarrhea besides CD.

* Has surgical bowel resection within 3 months of study.

* Has prior or current gastrointestinal dysplasia.

* Has chronic infection requiring ongoing antimicrobial treatment.

* Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \<5 years.

* Is infected with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or human immunodeficiency virus (HIV).

* Has active tuberculosis.

* Has confirmed or suspected coronavirus disease of 2019 (COVID-19) infection.

* Prior exposure to tulisokibart (MK-7240, PRA023) or another anti-tumor necrosis factor-like cytokine 1A (TL1A) antibody (Ab).

Dates on the record

Started 5 June 2024

Estimated completion 30 October 2028

Registry last updated 13 October 2026

Checked by Voxsanity 15 October 2026

Results, publications and the official record

No results are posted on the official record yet.
No publications are listed on the official record yet.
Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.

Sources and dates

ClinicalTrials.gov – the record this page reformats
ClinicalTrials.gov processing date: 13 October 2026.
This page last checked by Voxsanity: 15 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.

Voxsanity

Clinical trials recruiting in Australia, from the public registries · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial, which may be relevant to my care:

Trial: NCT06430801

Sponsor: Merck Sharp & Dohme LLC

Phase: Phase 3

Status: Recruiting

Condition: Crohn's Disease and Colitis

More information: https://clinicaltrials.gov/study/NCT06430801

Eligibility criteria, as the registry published them

Reproduced exactly, unedited. Written for researchers rather than for patients.

The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

Has had a diagnosis of Crohn's disease (CD) at least 3 months before study.
Has moderately to severely active CD.
Demonstrated inadequate response, loss of response, or intolerance to one or more of the following categories of drugs: oral locally acting steroids, systemic steroids, immunomodulators, biologic and/or small molecule advanced therapies.
Adolescent participants ≥16 and <18 years of age can participate if approved by the country or regulatory/health authority.

Exclusion Criteria:

Has diagnosis of ulcerative colitis (UC) or indeterminate colitis.
Has CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement.
Currently has any of the following complications of CD: suspected or diagnosed with intra-abdominal or perianal abscess, known symptomatic stricture or colonic stenosis not passable in endoscopy, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.
Has current stoma or need for colostomy or ileostomy.
Is missing >2 segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.
Has been diagnosed with short gut or short bowel syndrome, or any other uncontrolled chronic diarrhea besides CD.
Has surgical bowel resection within 3 months of study.
Has prior or current gastrointestinal dysplasia.
Has chronic infection requiring ongoing antimicrobial treatment.
Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for <5 years.
Is infected with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
Has active tuberculosis.
Has confirmed or suspected coronavirus disease of 2019 (COVID-19) infection.
Prior exposure to tulisokibart (MK-7240, PRA023) or another anti-tumor necrosis factor-like cytokine 1A (TL1A) antibody (Ab).

A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a registered health practitioner to access unapproved therapeutic goods for individual patients.

Not medical advice. Voxsanity reformats information published by public registries. It does not give medical advice and is not a substitute for talking to your doctor.