NOV-ERA - A Clinical Trial to Assess the Efficacy and Safety of Ontunisertib Compared to Placebo in Patients With Fibrostenosing Crohn's Disease

NCT07683325
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Phase
Phase 2
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Recruitment status
Recruiting
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Participants
320
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Lead sponsor
Agomab Spain S.L.U.
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Start date
2026-10-30
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Number of sites
11
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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.
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Short title
NOV-ERA - A Clinical Trial to Assess the Efficacy and Safety of Ontunisertib Compared to Placebo in Patients With Fibrostenosing Crohn's Disease
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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
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2029-06-30
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First posted
2026-07-06
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Registry last updated
2026-10-29
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Primary completion date
2028-12-31
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Start date
2026-10-30
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Participants
320
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Participant count basis
Estimated
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Planned participants
320
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Protocol amendments
0
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Randomisation ratio
1:1:1:1
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Number of sites
11
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Agomab Spain S.L.U.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07683325
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ClinicalTrials.gov ID
NCT07683325
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masking description
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

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

    Timeframe: At week 24

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

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

    Timeframe: At week 52

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

  2. Change in reliable MRE imaging features (stricture length, bowel wall thickness, prestenotic dilatation diameter) of the index stricture

    Timeframe: At week 52 compared to baseline (week 1)

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

  3. Change in total SES-CD (range, 0-56 points) (Reference: https://www.giejournal.org/article/S0016-5107(04)01878-4/abstract)

    Timeframe: At week 52 compared to baseline

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

  4. Proportion of participants with an endoscopic response (≥50% decrease in total SES-CD) and remission (SES-CD ≤4 with no item >1)

    Timeframe: At week 52 compared to baseline

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

  5. Change in S-PRO severity score

    Timeframe: At week 52 compared to baseline

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

  6. Time to an FSCD- related event

    Timeframe: From baseline to week 52

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

  7. Number of participants with adverse events (AEs)

    Timeframe: From baseline to week 52

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

  8. Number of participants with abnormal clinical laboratory tests

    Timeframe: From baseline to week 52

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

  9. Number of participants with abnormal ECG parameters

    Timeframe: From baseline to week 52

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

  10. Number of participants with abnormal vital signs

    Timeframe: From baseline to week 52

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

  11. Number of participants with abnormal physical examinations

    Timeframe: From baseline to week 52

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

  12. Plasma level concentration of ontunisertib and metabolites

    Timeframe: From baseline to week 52

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

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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.

  • 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.

Sources for eligibility
clinicaltrials.gov

  • GI AllianceSun City, United StatesRecruiting
  • Synergy Healthcare, LLCBradenton, United StatesRecruiting
  • Albany Gastroenterology ConsultantsAlbany, United StatesRecruiting
  • University GastroenterologyProvidence, United StatesRecruiting
  • GI AllianceCedar Park, United StatesRecruiting
  • GI Alliance - Fort WorthFort Worth, United StatesRecruiting
  • Amel Med LLCGeorgetown, United StatesRecruiting
  • Belgrade, SerbiaRecruiting
  • Clinical Hospital Center Bezanijska KosaBelgrade, SerbiaRecruiting
  • Clinical Hospital Center Zvezdara (CHCZ)Belgrade, SerbiaRecruiting
  • Royal London HospitalLondon, United KingdomRecruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)