Strictures Due to Crohn's DiseasePhase 2ROCKETEERNCT07832435
A Phase 2, Placebo-Controlled Study of Oral RXC008 for Crohn's Strictures
A Phase 2 study testing High Dose and Low Dose in people with Strictures Due to Crohn's Disease, run by Redx Pharma Ltd.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Strictures Due to Crohn's Disease
- What is being tested?
- High Dose and Low Dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 22 Feb 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%).
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- 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.
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the detailed description
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.
- Conditions
- Strictures Due to Crohn's Disease
- Being tested
- High Dose, Low Dose, Placebo
- Keywords
- Strictures, Crohn's disease, Inflammatory Bowel Disease (IBD), Rho-associated Coiled Coil Kinase (ROCK)
- Medical subject headings
- Constriction, Pathologic, Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High DoseDrug
RXC008 High dose
Low DoseDrug
RXC008: low dose
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| High dose | Experimental | Not described Receives: Drug: High Dose |
| Low dose | Experimental | Not described Receives: Drug: Low Dose |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change from baseline in primary stricture.
Absolute change from baseline in primary stricture at Week 24, measured by Magnetic Resonance Enterography (MRE).
Measured: At week 24.
Secondary outcomes (5)
Change from baseline in stricture passability.
Change from baseline in stricture passability (passable or non-passable) via ileocolonoscope.
Measured: 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).
Measured: At week 24 and at week 48.
Treatment-Emergent Adverse Events.
The incidence of Treatment-Emergent Adverse Events (TEAEs).
Measured: At week 24 and week 48.
Serious Adverse Events.
The incidence of Serious Adverse Events (SAEs).
Measured: At week 24 and week 48.
Adverse Events.
The incidence of discontinuations due to Adverse Events (AEs).
Measured: At week 24 and at week 48.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion22 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Strictures Due to Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized 1:1:1 across 3 treatment groups.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Redx Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07832435
- Sponsor's protocol ID
- RXC008-0002
- Other IDs
- 2026-527843-16-00
- Acronym
- ROCKETEER
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- ROCKETEER / RXC008-0002
- Conditions
- Strictures Due to Crohn's Disease
- Keywords
- Strictures, Crohn's disease, Inflammatory Bowel Disease (IBD), Rho-associated Coiled Coil Kinase (ROCK)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Redx Pharma LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 22 Feb 2029 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomized 1:1:1 across 3 treatment groups.
| Arm | Type | Receives |
|---|---|---|
| High dose | Experimental | Drug: High Dose |
| Low dose | Experimental | Drug: Low Dose |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High DoseRXC008 High dose | Drug | High dose |
| Low DoseRXC008: low dose | Drug | Low dose |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Absolute change from baseline in primary stricture.
Time frame: At week 24.
Absolute change from baseline in primary stricture at Week 24, measured by Magnetic Resonance Enterography (MRE).
5 secondary outcomes
Change from baseline in stricture passability.
Time frame: At week 24 and at week 48.
Radiographic stenosis response.
Time frame: At week 24 and at week 48.
Treatment-Emergent Adverse Events.
Time frame: At week 24 and week 48.
Serious Adverse Events.
Time frame: At week 24 and week 48.
Adverse Events.
Time frame: At week 24 and at week 48.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing High Dose and Low Dose in people with Strictures Due to Crohn's Disease, run by Redx Pharma Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Head of Clinical Operations (+44(0)7787 983 638, ctilston@redxpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute change from baseline in primary stricture. (time frame: At week 24.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.