NCT07832435Not yet recruitingPhase 2
A Phase 2, Placebo-Controlled Study of Oral RXC008 for Crohn's Strictures
Multicentre, Placebo-controlled Randomised, Double Blind, Phase 2 Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of RXC008 in Participants With Strictures Due to Crohn's Disease Following Treatment With Orally Administered RXC008
Source: ClinicalTrials.gov · Last updated 22 Sept 2026
Brief summary (registry, in English)
Crohn's disease (CD) is chronic inflammatory bowel disease where any part of the Gastrointestinal (GI) tract can become inflamed and develop fibrotic strictures. Intestinal strictures cause abdominal distension, cramping, dietary restrictions, nausea, vomiting, abdominal pain, and postprandial abdominal pain, which significantly impact patient quality of life. Rho-associated coiled-coil kinase (ROCK) family of proteins including ROCK1 and ROCK2 have been shown to play an important role in these fibrotic strictures. The investigational agent, RXC008, is an inhibitor of the activity of ROCK1 and ROCK2. The study will assess efficacy, safety, PK and PD of RXC008 in comparison with placebo for up to 48 weeks in participants with fibrotic strictures who are also receiving standard-of care background anti-inflammatory therapy.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- First submitted
- 16 Sept 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 31 Aug 2028
- Lead sponsor
- Redx Pharma Ltd
- Diseases
- Crohn's disease
- NCT number
- NCT07832435
- EU CT number
- 2026-527843-16-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 180
- From 1 Oct 2026 to the primary completion date, 31 Aug 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Other colitis diagnoses (e.g. ulcerative, indeterminate, ischaemic, NSAID-induced, microscopic, radiation).
- Likely to require endoscopic balloon dilation or surgery within 6 months, in the opinion of the investigator.
- Received either endoscopic balloon dilation or intestinal surgery within the past 6 months.
- Prohibited concomitant medications; prior RXC008 exposure; recent/concurrent participation in another interventional study (per protocol windows).
Other illness
- Severe disease activity as measured by Crohn's Disease Activity Index (CDAI).
- Intestinal dysplasia/malignancy.
- Major surgery within 8 weeks pre-randomisation or planned during the study; extensive resections/proctocolectomy; short gut syndrome (≤200 cm small bowel).
- Active septic/penetrating complications of CD (e.g., fistulas, abscess, phlegmon), pouches/ostomies, anal/perianal strictures, toxic megacolon, inability to eat, or current hospitalisation for Crohn's disease.
Who the study is looking for
- BMI >16 to ≤40 kg/m2; written informed consent.
- Symptomatic strictures based on S-PRO2 criteria.
- ≤2 small bowel strictures (naïve, native or anastomotic) confirmed by central MRE read; primary lesion is most distal and reachable by ileocolonoscopy.
- MRE features consistent with stricture, including:
- Luminal narrowing (≥50%).
- Bowel wall thickening (≥25%).
- Pre-stenotic dilatation (≥25 mm).
- Stable background Crohn's therapy after induction with no planned changes for study duration (biologics must be stable for ≥12 weeks prior to screening, with shorter windows for other medication classes as defined in the protocol).
- Screening labs and vital signs within protocol-defined limits; pregnancy prevention requirements met.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.