A Phase 2 interventional study of High Dose and Low Dose in Strictures Due to Crohn's Disease, sponsored by Redx Pharma Ltd. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Redx Pharma Ltd · Phase 2, Interventional, and Treatment
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.
RXC008 is an investigational GI-restricted inhibitor of ROCK1 and ROCK2 for the treatment of fibrostenosis due to CD. The study will assess efficacy, safety, systemic PK and PD of RXC008 versus placebo in participants with strictures due to CD.
This multi-centre, randomized, double-blind, placebo-controlled Phase 2 study will evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of orally administered RXC008 compared to a matching placebo over a treatment period of up to 48 weeks.
Following a formal screening period to confirm eligibility, participants on stable background anti-inflammatory therapy will be randomized 1:1:1 to receive either a high dose of RXC008, a low dose of RXC008, or a matched placebo, administered orally.
Key study procedures and protocol-specified assessments will be performed at designated intervals throughout the trial. Radiographic changes in stricture anatomy will be monitored via central reads of Magnetic Resonance Enterography (MRE) scans. while stricture passability will be evaluated via ileocolonoscopy.
Additionally, daily patient-reported outcome (S-PRO2) diaries will be utilized to track the severity and frequency of obstructive symptoms directly from the participant's perspective. Regular blood sampling will also be conducted to characterize systemic drug exposure and safety profiles.
RXC008 is presented for oral administration. Matched placebo will be presented in identical containers and stored / packaged the same as RXC008. Packaging, labelling and preparation of the study medication will be performed in a way that will ensure blinding throughout the cohort.
Primary Objective: To assess the safety and efficacy of RXC008 administered orally daily for up to 24 weeks in participants with strictures due to Crohn's disease who are on stable background anti-inflammatory therapy.
Secondary Objective: Characterise the PK and evaluate RXC008 safety and efficacy administered daily for 48 weeks for Crohn's patients on stable background anti-inflammatory therapy.
Approximately 180 participants will be randomized 1:1:1 to RXC008 High dose: RXC008 Low dose or placebo.
456 studies on the registry are indexed under Constriction, Pathologic; 109 are open to participants now.
This study's planned enrollment of 180 is above the median of 72 across 295 interventional studies indexed under Constriction, Pathologic.
Browse Constriction, Pathologic studies →Redx Pharma Ltd is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
MRE features consistent with stricture, including:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: High Dose
Drug: Low Dose
Drug: Placebo
RXC008 High dose
RXC008: low dose
Placebo
Absolute change from baseline in primary stricture.
Absolute change from baseline in primary stricture at Week 24, measured by Magnetic Resonance Enterography (MRE).
Time frame: At week 24.
Change from baseline in stricture passability.
Change from baseline in stricture passability (passable or non-passable) via ileocolonoscope.
Time frame: At week 24 and at week 48.
Radiographic stenosis response.
Radiographic stenosis response (≥25% improvement in primary stricture length or ≥50% improvement in pre-stenotic dilation without worsening of primary stricture length AND no new small bowel stenosis, no new stricture associated fistula, and no new stenotic abscess).
Time frame: At week 24 and at week 48.
Treatment-Emergent Adverse Events.
The incidence of Treatment-Emergent Adverse Events (TEAEs).
Time frame: At week 24 and week 48.
Serious Adverse Events.
The incidence of Serious Adverse Events (SAEs).
Time frame: At week 24 and week 48.
Adverse Events.
The incidence of discontinuations due to Adverse Events (AEs).
Time frame: At week 24 and at week 48.
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Aug 2028, 22 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Redx Pharma Ltd