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Efficacy and safety of ontunisertib in patients with fibrostenosing Crohn’s disease: a phase 2b randomized, double‑blind, placebo‑controlled dose‑ranging trial

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What is this study about?

The study focuses on Fibrostenosing Crohn’s Disease, a form of Crohn’s disease where scar tissue causes narrowing and blockage of the intestine. The investigational medicine being examined is ontunisertib, given as oral capsules in two strength levels (200 mg and 800 mg). Participants will be randomly assigned to receive either one of the active doses or a matching placebo that looks the same but contains no active drug.

The aim is to determine whether the drug improves the ability of the intestine to open up and reduces disease activity, and to see how the different doses compare. Over a period of up to one year, participants will take the study medication each day, undergo an endoscopic examination of the intestine and a special imaging test called MRE at approximately 24 and 52 weeks, and have routine safety checks that include blood tests, vital‑sign measurements, an ECG, and physical examinations. Researchers will also track side effects, referred to as TEAEs, and use a scoring system known as SES‑CD to evaluate changes in disease severity.

1 enrollment and consent

after joining the study, you will sign an informed consent form and complete the screening procedures required to confirm eligibility.

2 baseline assessments

the study team will perform an endoscopic examination of the ileum, imaging studies, and laboratory tests to record your condition before any medication is given.

3 randomization to study group

you will be randomly assigned, without knowing the result, to receive either ontunisertib 200 mg, ontunisertib 800 mg, or a placebo capsule. the assignment is double‑blind, meaning neither you nor the investigators will know which group you are in.

4 start of study medication

you will take one oral capsule each day. the capsule contains either 200 mg of ontunisertib, 800 mg of ontunisertib, or no active drug (placebo).

the daily dosing will continue for up to 52 weeks unless the study team advises otherwise.

5 mid‑study evaluation (week 24)

at week 24, you will return for a follow‑up visit that includes another endoscopic examination to see if the ileal stricture is passable, imaging studies, and safety assessments such as lab tests and vital‑sign checks.

6 final evaluation (week 52)

at week 52, a final visit will be scheduled. the same endoscopic and imaging assessments performed at week 24 will be repeated, along with safety evaluations and questionnaires about symptom severity.

after the week 52 assessments, the study medication will be discontinued.

Who Can Join the Study?

  • Have a diagnosis of Crohn’s disease that affects the ileum (the end part of the small intestine) or both the ileum and colon, confirmed by a doctor using symptoms and an endoscopic (camera‑based) or radiological (scan‑based) exam at least 12 weeks before signing the consent form.
  • Have at least one narrowing, called a stricture, in the ileum that an endoscope cannot pass through.
  • The narrowing can be a new (naïve) stricture or one that formed at a previous surgical connection (an anastomotic stricture), and it must be confirmed by a centrally reviewed magnetic resonance enterography (MRE) scan.
  • Experience symptoms of partial blockage (such as abdominal pain, cramping, feeling full quickly) or need to limit the amount or type of food they can eat.
  • Be taking a stable dose of medication that reduces inflammation for Crohn’s disease and agree to keep this medication unchanged for the whole study.
  • Not be expected, in the doctor’s opinion, to need hospitalization, an endoscopic balloon dilation (a procedure that widens a stricture with a small balloon), surgical removal of part of the intestine (surgical resection), or a stronger anti‑inflammatory treatment during the first four weeks of the trial.
  • Have a body mass index (BMI) of at least 18 and less than 35 kg/m², which is a measure of weight relative to height.
  • Be a male or female patient who meets the age requirements set by the study.

Who Cannot Join the Study?

  • You have ever had or currently have any type of colon inflammation (colitis), such as ulcerative colitis, indeterminate colitis, ischemic colitis, NSAID‑induced colitis, idiopathic colitis, radiation colitis, microscopic colitis, colonic mucosal dysplasia, untreated bile‑acid malabsorption, or infectious colitis.
  • You have major Crohn’s disease complications, including a very short remaining small intestine (short bowel syndrome with less than 200 cm left), surgical openings like an ileostomy, colostomy, small‑bowel stoma, or ileoanal pouch, internal abnormal connections (fistulas or sinus tracts) from the narrowed area, untreated abdominal or perianal abscess, severe widening of the colon (toxic megacolon), or anal/perianal narrowing (stricture).
  • You have had an endoscopic balloon dilation or surgery on the same small‑bowel narrowing within the last six months.
  • You have current or past heart valve disease (valvulopathy) or moderate to severe valve problems, or a reduced heart pumping ability (left ventricular ejection fraction below 50%).
  • You have any other serious acute or chronic medical condition, psychiatric disorder, abnormal laboratory test, or infection that could increase risk or affect the study’s results.
  • You have significant abnormal lab values or heart‑electrical test (ECG) findings at screening, such as abnormal blood counts, liver function tests, vital signs, or ECG measures like a PR interval ≥ 220 ms, QRS ≥ 120 ms, prolonged QTc (>450 ms for men or >470 ms for women), very slow heart rate, ST‑segment changes, bundle‑branch block, or any other ECG abnormality that would interfere with measuring the QT interval.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Hopital Beaujon Clichy France
Vojenska Nemocnice Brno Brno-Zidenice Czechia
SurGal Clinic s.r.o. Brno-Sever Czechia
H-T. Centrum Medyczne Sp. z o.o. Tychy Poland
Medrise Sp. z o.o. Lublin Poland
SPZOZ Ministerstwa Spraw Wewnętrznych i Administracji w Kielcach im. Św. Jana Pawła II Kielce Poland
Ocyafp Urfdqmfpym Haqdbcmm Odense Denmark
Hhexyl Hdibgikj Herlev Denmark
Asczgxjcax Pqojikoy Higxsotv Du Mdmrcnqfo Marseille France
Brcblrjq Ucqrsvsyjl Hvgdsnju Cjusgl Besançon France
Rarohz Mjywcqyypte Aarhus Denmark
Cqloln Mcnjli Caeumkwawif Atskzwve Phpq Hkxydimw Neuilly-Sur-Seine France
Cyttwx Hpsleujndwr Uwnstledhyhyk Db Rgkxdd Rennes France
Rtapzqqgbjxbdv Copenhagen Denmark
Rlrvtgzn Unelrqzipq Roskilde Denmark
Clrdiozro Ugmghbtgkgqcii Smvkbpaob Woluwe-Saint-Lambert Belgium
Anwgvntymg Friwflffyah Dmkvyxey Kcyoahft gwnpa Frankfurt Germany
Ujdreflmcwgwlvnmrxwgv Tbbsupyxp Azd Tuebingen Germany
Agaccupye Uby Amsterdam The Netherlands
Uxoxxxllzrle Mkpqqpi Ctvamfg Utosbmq Utrecht The Netherlands
Cootmws Ubgambhdohlcolvpfrtn Biztcp Kex Berlin Germany
Ffxlgihp Nuvduvhjm Bztq Brno Czechia
Spgoiqsfe Rnwzgfr Udgfhlyjde Mnbnxlz Ccilqt Nijmegen The Netherlands
Cvv Mfoibfbmz Liege Belgium
Kpnwcbqp dxy Tievykhqmcg Ufamfkxzlial Menarviv (asu Kkzclisjv Munich Germany
Ilomyw awoy Prague Czechia
Igdrbbjx fwku Kdtisvbsd Tdxdoacwflyoelcoqxq una Ioukvjyzqjzd Uxr ghvfq Ulm Germany
Uaoeoenndupa Zidvchkaao Grri Gent Belgium
Uddestyjfsmo Mlsbmqq Cxqvqcj Gmrgnwhhg Groningen The Netherlands
Azrvrlge Zuxkxniekk Dhjrw Roeselare Belgium
Ixctez Bonheiden Belgium
Csckjd Heyiojynlgt Uotyioboiqelg Dmiorn Glspwdb Sgncmvvamnammdafphcavliamx Namur Belgium
Enm Zzzddf Zamosc Poland
Cnrytki Mjtnjcqp Mdebl Sud z oivn Rzeszow Poland
Eo Gotwe Spq z osjv Warsaw Poland
Eadhzbmish Siq z ouyt Sopot Poland
Woo Wwcndq Icu Paxyx Piaurzaf Klljocw Warsaw Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not yet recruiting
31.12.2026
Czechia Czechia
Not yet recruiting
31.12.2026
Denmark Denmark
Not yet recruiting
31.12.2026
France France
Not yet recruiting
31.12.2026
Germany Germany
Not yet recruiting
31.12.2026
Poland Poland
Not yet recruiting
31.12.2026
The Netherlands The Netherlands
Not yet recruiting
31.12.2026

Trial locations

Investigated Drugs:

Ontunisertib is an experimental oral medication given in capsule form that is being studied in this trial. It is designed to affect the biological processes that cause inflammation and narrowing of the intestine in fibrostenosing Crohn’s disease. The study is testing different amounts of the drug to learn how well it works and how safe it is for patients.

Fibrostenosing Crohn’s disease – It is a form of Crohn’s disease where ongoing inflammation produces scar tissue that narrows the intestine. The condition progresses with repeated flare‑ups that increase the thickness of the bowel wall. Over time the narrowed segments, called strictures, can become more fibrotic and may impede the passage of food. As strictures develop, people often feel abdominal pain, cramping, and changes in bowel habits. The disease can affect any part of the gastrointestinal tract, most commonly the ileum.

Trial ID:
2026-525197-19-00
Protocol code:
AGMB129-01-CL-201
Trial Phase:
Therapeutic exploratory (Phase II)

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