> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/nov-era-a-clinical-trial-to-assess-the-efficacy-and-safety-73e2e553-07e1-4768-8b04-7b0b30fdb5b6 > Record changed: 2026-11-04 # NOV-ERA - A Clinical Trial to Assess the Efficacy and Safety of Ontunisertib Compared to Placebo in Patients With Fibrostenosing Crohn's Disease NCT07683325 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07683325) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07683325) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07683325) Participants 320 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07683325) Lead sponsor Agomab Spain S.L.U. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07683325) Start date 2026-10-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07683325) Number of sites 11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07683325) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07683325) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07683325) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07683325) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07683325) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07683325) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07683325) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07683325) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07683325) ## Dates **Completion date** 2029-06-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07683325) **First posted** 2026-07-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07683325) **Registry last updated** 2026-10-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07683325) **Primary completion date** 2028-12-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07683325) **Start date** 2026-10-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07683325) ## Size and sites **Participants** 320 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07683325) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07683325) **Planned participants** 320 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07683325) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07683325) **Randomisation ratio** 1:1:1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07683325) **Number of sites** 11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07683325) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07683325) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07683325) **Lead sponsor** Agomab Spain S.L.U. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07683325) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07683325) ## Identifiers **Registry ID** NCT07683325 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07683325) **ClinicalTrials.gov ID** NCT07683325 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07683325) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07683325) ## Study design **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07683325) ## Outcomes ### Primary outcomes 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 ### Secondary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07683325) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **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 - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07683325) ## Sites - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07683325) ## Related records ### Drugs (1) - [Ontunisertib](https://trialight.com/data/asset/ontunisertib-f9efe5b2-b085-5da8-853c-56191a5acdd5.md) ### Lead sponsors (1) - [Agomab Spain S.L.U.](https://trialight.com/data/company/agomab-spain-s-l-u-1d751b89-cb09-466f-aa09-badfcfcbe39b.md) ### Conditions (1) - [Crohn disease](https://trialight.com/data/condition/crohn-disease-f7aa2cd8-9680-56b5-858c-2b75f88fb0d0.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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