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RecruitingNCT07683325Updated Oct 5, 2026

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 interventional study of Ontunisertib and Ontunisertib in Fibrostenotic Crohn's Disease, sponsored by Agomab Spain S.L.U.. Recruiting at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-05.

Sponsored by Agomab Spain S.L.U. · Phase 2, Interventional, and Treatment

Updated Oct 5, 20262 sites addedGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
320
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Fibrostenotic Crohn's Disease
03

In context

Lead sponsor

Agomab Spain S.L.U. is the lead sponsor of 5 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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:

    1. Short bowel syndrome (\<200 cm small bowel remaining).
    2. Ileostomy (diverting or end), colostomy, small bowel stoma, or ileoanal pouch.
    3. Internal fistulae and sinus tracts deriving from the area of stenosis. Participants with perianal fistulae could be included if not septic.
    4. Anal and perianal stricture.
    5. Suspected or diagnosed active intra-abdominal or perianal abscess that has not been appropriately treated and abscess in relation to the stricture.
    6. Toxic megacolon.
    7. 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
320 participants (estimated)

Study arms

  • Experimental
    Ontunisertib High

    Ontunisertib high dose

    Drug: Ontunisertib

  • Experimental
    Ontunisertib Medium

    Ontunisertib medium dose

    Drug: Ontunisertib

  • Experimental
    Ontunisertib Low

    Ontunisertib low dose

    Drug: Ontunisertib

  • Experimental
    Placebo

    Matching placebo

    Drug: Placebo

Interventions

  • DrugOntunisertib

    Oral capsule

    Also known as: AGMB-129

  • DrugOntunisertib

    Oral capsule

    Also known as: AGMB-129

  • DrugOntunisertib

    Oral capsule

    Also known as: AGMB-129

  • DrugPlacebo

    Matching oral capsule

06

What researchers measure

Primary outcomes

  1. Proportion of participants achieving endoscopic passability of the ileal index stricture

    To evaluate the efficacy and dose-response relationship of multiple doses of ontunisertib

    Time frame: At week 24

Secondary outcomes

  1. Proportion of participants achieving endoscopic passability of the ileal index stricture

    To evaluate the efficacy of ontunisertib in participants with FSCD, compared to placebo

    Time frame: At week 52

  2. 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

    Time frame: At week 52 compared to baseline (week 1)

  3. 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

    Time frame: At week 52 compared to baseline

  4. 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

    Time frame: At week 52 compared to baseline

  5. Change in S-PRO severity score

    To evaluate the efficacy of ontunisertib in participants with FSCD, compared to placebo

    Time frame: At week 52 compared to baseline

  6. Time to an FSCD- related event

    To evaluate the efficacy of ontunisertib in participants with FSCD, compared to placebo

    Time frame: From baseline to week 52

  7. Number of participants with adverse events (AEs)

    To evaluate the safety and tolerability of ontunisertib in participants with FSCD, compared to placebo

    Time frame: From baseline to week 52

  8. Number of participants with abnormal clinical laboratory tests

    To evaluate the safety and tolerability of ontunisertib in participants with FSCD, compared to placebo

    Time frame: From baseline to week 52

  9. Number of participants with abnormal ECG parameters

    To evaluate the safety and tolerability of ontunisertib in participants with FSCD, compared to placebo

    Time frame: From baseline to week 52

  10. Number of participants with abnormal vital signs

    To evaluate the safety and tolerability of ontunisertib in participants with FSCD, compared to placebo

    Time frame: From baseline to week 52

  11. Number of participants with abnormal physical examinations

    To evaluate the safety and tolerability of ontunisertib in participants with FSCD, compared to placebo

    Time frame: From baseline to week 52

  12. Plasma level concentration of ontunisertib and metabolites

    To evaluate the PK (AUC) of ontunisertib in participants with FSCD

    Time frame: From baseline to week 52

07

Study locations

4 of 4 sites recruiting
  • Synergy Healthcare, LLC
    Bradenton, Florida 34209, United States
    Recruiting
  • University Gastroenterology
    Providence, Rhode Island 02905, United States
    Recruiting
  • GI Alliance - Fort Worth
    Fort Worth, Texas 76104, United States
    Recruiting
  • Amel Med LLC
    Georgetown, Texas 78628, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

2 registry updates since Sep 25, 2026
Sites
2 sites added
Show 2 added (2 United States)
  • Amel Med LLC · Georgetown, United States
  • University Gastroenterology · Providence, United States
across 2 updates, Sep 28, 2026 – Oct 5, 2026
Show all 2 updates
  1. Oct 5, 2026
    1 site added
    Show site
    • University Gastroenterology · Providence, United States
    + 1 other change: verification date
  2. Sep 28, 2026
    1 site added
    Show site
    • Amel Med LLC · Georgetown, United States
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07683325
Lead sponsor
Agomab Spain S.L.U.
Responsible party
Sponsor
First posted
Jul 6, 2026
Start date
Oct 30, 2026 (estimated)
Primary completion
Dec 31, 2028 (estimated)
Completion
Jun 30, 2029 (estimated)
Last update
Oct 5, 2026

Study contacts

Agomab Clinical Operations
Contact
clinicalstudies@agomab.com
0032 3318 91 70
Silke Hüttner, MD
study director · Agomab Therapeutics

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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