A Phase 2, Placebo-Controlled Study of Oral RXC008 for Crohn's Strictures
Phase 2 · Testing High Dose and Low Dose · Sites not listed yet · Redx Pharma Ltd
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing High Dose (a drug) and Low Dose (a drug) as a possible treatment. Condition(s) listed: Strictures Due to Crohn's Disease.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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.
Plus 6 more requirement(s). There are also 8 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 180 participants are expected to take part.
- Start date: 2026-10-01 (planned).
- Main results expected around 2028-08-31 (estimate from the record).
- No study sites are listed yet. Check the official record for contact details.
Main thing being measured
- Absolute change from baseline in primary stricture. (At week 24.)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Strictures Due to Crohn's Disease |
| Lead sponsor | Redx Pharma Ltd |
| Enrollment | 180 (estimated) |
| Start date | 2026-10-01 |
| Primary completion (est.) | 2028-08-31 |
| First posted | 2026-09-22 |
| Last updated | 2026-09-22 |
| Official title | 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 |
| ClinicalTrials.gov ID | NCT07832435 |
Interventions
- High Dose (Drug)
RXC008 High dose - Low Dose (Drug)
RXC008: low dose - Placebo (Drug)
Placebo
Full eligibility criteria (from the record)
Inclusion Criteria: * 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. Exclusion Criteria: * Severe disease activity as measured by Crohn's Disease Activity Index (CDAI). * Other colitis diagnoses (e.g. ulcerative, indeterminate, ischaemic, NSAID-induced, microscopic, radiation). * Intestinal dysplasia/malignancy. * 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. * 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. * Prohibited concomitant medications; prior RXC008 exposure; recent/concurrent participation in another interventional study (per protocol windows).
Locations (0)
No sites listed yet. The official record has contact information.
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.