Fibrostenotic Crohn's DiseasePhase 2NCT07683325
NOV-ERA - A Clinical Trial to Assess the Efficacy and Safety of Ontunisertib Compared to Placebo in Patients With Fibrostenosing Crohn's Disease
A Phase 2 study testing Ontunisertib in people with Fibrostenotic Crohn's Disease, run by Agomab Spain S.L.U. at 5 sites in United States.
Trial summary
Many patients with Crohn's disease (CD) develop fibrotic narrowing (strictures) in their bowel, causing obstructive symptoms such as abdominal pain, cramping, or vomiting after meals. Because of these symptoms, patients often require bowel resection surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibrostenotic Crohn's Disease
- What is being tested?
- Ontunisertib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 5 sitesUnited States
- Study dates
- 30 Oct 2026to 30 Jun 2029
- Phase
- Phase 2
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
- Diagnosis of ileal or ileocolonic CD based on clinical and endoscopic or radiological evidence established at least 12 weeks prior to signing the ICF.
- Presence of at least 1 endoscopically non-passable ileal stricture.
- Present stricture(s) can be naïve or anastomotic, and will be confirmed by centrally read MRE.
- Presence of (sub)obstructive symptoms AND/OR dietary restrictions like limiting the amount or type of food, and/or food processing methods.
- Participants should be on stable anti-inflammatory background therapy for CD and agree to maintain stable background therapy for the duration of the trial.
- Participants should have a body mass index ≥18 kg/m2 and <35 kg/m2.
- Not expected in the investigator's opinion to require hospitalization, endoscopic balloon dilation, surgical resection, or optimized anti-inflammatory therapy during the first 4 weeks of the trial.
Who cannot join
- History or current diagnosis of ulcerative colitis, indeterminate colitis, ischemic colitis, nonsteroidal anti-inflammatory drug-induced colitis, idiopathic colitis (i.e., colitis not consistent with CD), radiation colitis, microscopic colitis, colonic mucosal dysplasia, untreated bile acid malabsorption, or infectious colitis.
- CD-related complications:
- Short bowel syndrome (<200 cm small bowel remaining).
- Ileostomy (diverting or end), colostomy, small bowel stoma, or ileoanal pouch.
- Internal fistulae and sinus tracts deriving from the area of stenosis. Participants with perianal fistulae could be included if not septic.
- Anal and perianal stricture.
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- Suspected or diagnosed active intra-abdominal or perianal abscess that has not been appropriately treated and abscess in relation to the stricture.
- Toxic megacolon.
- Blind-ending sinus could be included.
- Endoscopic balloon dilation or surgical treatment of the index small bowel stricture within the last 6 months prior to screening.
- Current or history of valvulopathy, or moderate or severe heart valve function defect, including moderate or severe valve stenosis or regurgitation OR left ventricular ejection fraction <50% as assessed locally through echocardiography.
- Any other severe acute or chronic medical condition, psychiatric disorder, laboratory abnormality, or systemic or opportunistic infection that may increase the risk associated with trial participation or trial treatment administration, or may interfere with the interpretation of trial results, as determined by the investigator.
- Clinically significant abnormal vital signs, physical examination, or abnormalities at 12-lead ECG at screening or baseline.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Albany Gastroenterology Consultants
Albany, New York, 12206
- Recruiting
Synergy Healthcare, LLC
Bradenton, Florida, 34209
- Recruiting
GI Alliance - Fort Worth
Fort Worth, Texas, 76104
- Recruiting
Amel Med LLC
Georgetown, Texas, 78628
- Recruiting
University Gastroenterology
Providence, Rhode Island, 02905
About this study
Official title: A Phase 2b, Randomized, Placebo-controlled, Double-blind, Dose-ranging Trial to Assess the Efficacy and Safety of Ontunisertib in Patients With Fibrostenosing Crohn's Disease
Many patients with Crohn's disease (CD) develop fibrotic narrowing (strictures) in their bowel, causing obstructive symptoms such as abdominal pain, cramping, or vomiting after meals. Because of these symptoms, patients often require bowel resection surgery. The objective of this clinical trial is to evaluate the efficacy, safety, and dose-response relationship of ontunisertib in participants with CD and symptomatic strictures, and contribute to the validation of novel endpoints to assess potential treatment benefit in patients with fibrostenosing Crohn's disease (FSCD).
The participants will be in the trial for a duration of up to 60 weeks, consisting of a 6-week screening period (with 2 screening visits), a 52-week treatment period, and a 2-week follow-up period. The visit frequency in the treatment period will be every 6 to 8 weeks.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, dose-ranging, multicenter Phase 2b trial to assess the efficacy and safety of ontunisertib in participants diagnosed with FSCD. The trial population will include adults 18 years of age and older with symptomatic FSCD based on clinical, endoscopic, and radiological criteria.
This trial consists of 3 periods (a screening period, a placebo-controlled, double-blind treatment period, and safety follow-up). After signing informed consent, eligibility will be assessed during a 6-week screening period. The presence of qualifying intestinal strictures will be assessed by ileocolonoscopy and magnetic resonance enterography (MRE). The presence of obstructive symptoms will also be evaluated.
Eligible participants will be randomized 1:1:1:1 to receive AGMB-129 (Ontunisertib) high dose, medium dose, low dose or placebo for 52 weeks.
During Screening and Weeks 24 and 52 visits, participants will undergo ileocolonoscopy with biopsy collection for exploring pharmacodynamics. Participants will have blood sample collection at Weeks 6, 12, 18, 24, 30, 36, 44 and 52 to assess safety, pharmacokinetics, and pharmacodynamics.
Throughout the study, participants will undergo routine safety assessments at study visits, which will include physical examination, vital signs, clinical laboratory assessment, electrocardiogram (ECG), and recording of AEs.
- Conditions
- Fibrostenotic Crohn's Disease
- Being tested
- Ontunisertib, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OntunisertibDrug
Also called AGMB-129
Oral capsule
OntunisertibDrug
Also called AGMB-129
Oral capsule
OntunisertibDrug
Also called AGMB-129
Oral capsule
PlaceboDrug
Matching oral capsule
| Study group | Role | What they receive |
|---|---|---|
| Ontunisertib High | Experimental | Ontunisertib high dose Receives: Drug: Ontunisertib |
| Ontunisertib Medium | Experimental | Ontunisertib medium dose Receives: Drug: Ontunisertib |
| Ontunisertib Low | Experimental | Ontunisertib low dose Receives: Drug: Ontunisertib |
| Placebo | Experimental | Matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants achieving endoscopic passability of the ileal index stricture
To evaluate the efficacy and dose-response relationship of multiple doses of ontunisertib
Measured: At week 24
Secondary outcomes (12)
Proportion of participants achieving endoscopic passability of the ileal index stricture
To evaluate the efficacy of ontunisertib in participants with FSCD, compared to placebo
Measured: At week 52
Change in reliable MRE imaging features (stricture length, bowel wall thickness, prestenotic dilatation diameter) of the index stricture
To evaluate the efficacy of ontunisertib in participants with FSCD, compared to placebo
Measured: At week 52 compared to baseline (week 1)
Change in total SES-CD (range, 0-56 points) (Reference: https://www.giejournal.org/article/S0016-5107(04)01878-4/abstract)
To evaluate the efficacy of ontunisertib in participants with FSCD, compared to placebo
Measured: At week 52 compared to baseline
Proportion of participants with an endoscopic response (≥50% decrease in total SES-CD) and remission (SES-CD ≤4 with no item >1)
To evaluate the efficacy of ontunisertib in participants with FSCD, compared to placebo
Measured: At week 52 compared to baseline
Change in S-PRO severity score
To evaluate the efficacy of ontunisertib in participants with FSCD, compared to placebo
Measured: At week 52 compared to baseline
Time to an FSCD- related event
To evaluate the efficacy of ontunisertib in participants with FSCD, compared to placebo
Measured: From baseline to week 52
Number of participants with adverse events (AEs)
To evaluate the safety and tolerability of ontunisertib in participants with FSCD, compared to placebo
Measured: From baseline to week 52
Number of participants with abnormal clinical laboratory tests
To evaluate the safety and tolerability of ontunisertib in participants with FSCD, compared to placebo
Measured: From baseline to week 52
Number of participants with abnormal ECG parameters
To evaluate the safety and tolerability of ontunisertib in participants with FSCD, compared to placebo
Measured: From baseline to week 52
Number of participants with abnormal vital signs
To evaluate the safety and tolerability of ontunisertib in participants with FSCD, compared to placebo
Measured: From baseline to week 52
Number of participants with abnormal physical examinations
To evaluate the safety and tolerability of ontunisertib in participants with FSCD, compared to placebo
Measured: From baseline to week 52
Plasma level concentration of ontunisertib and metabolites
To evaluate the PK (AUC) of ontunisertib in participants with FSCD
Measured: From baseline to week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start30 Oct 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibrostenotic Crohn's 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
- Randomized, placebo-controlled, double-blind, parallel, multicenter, phase 2b study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Agomab Spain S.L.U.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Silke Hüttner, MD, Study director, Agomab Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07683325
- Sponsor's protocol ID
- AGMB129-01-CL-201
- Status last verified
- Oct 2026
- First submitted
- 24 Jun 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No