Phase 3 Ankylosing Spondylitis Trial, Recruiting NCT05654753 Sponsor: Assistance Publique - Hôpitaux de Paris Condition: Ankylosing Spondylitis
Back to Ankylosing Spondylitis

Phase 3 Ankylosing Spondylitis Trial, Recruiting

NCT05654753
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are between 18 and 75 years old and have been diagnosed with axial spondyloarthritis (a type of inflammatory spine condition), with or without changes visible on an X-ray.
  • Your condition is still active — meaning your symptoms score 4 or higher (out of 10) on a standard symptom scale, and your back pain also scores 4 or higher, even after at least 6 months of treatment with at least 2 different anti-inflammatory medicines and at least one biological therapy (a type of advanced medication).
  • You may continue taking certain medicines (such as anti-inflammatories, some disease-modifying drugs, or low-dose steroids) as long as the doses have not changed in the 4 weeks before the study starts.
  • You may continue taking certain advanced biological or targeted therapies as long as the doses have not changed in the 3 months before the study starts.
  • If you are a woman who could become pregnant, you must be using effective contraception during at least the main treatment phase of the trial.
  • You have health insurance coverage (certain types may be excluded — confirm with trial site).
  • You are willing to sign a consent form and follow the study plan.

Who may not be able to join:

  • You are under a legal guardianship or protection order.
  • The study doctor believes you may have difficulty following the study rules, or there is a language or cognitive barrier that would prevent participation.
  • You are currently pregnant or breastfeeding.
  • You have inflammatory bowel disease (such as Crohn's disease or ulcerative colitis) that is currently active.
  • You have had a steroid injection in the 4 weeks before joining the study.
  • You currently have an active infection.
  • You have taken antibiotics (including sulfasalazine) or antifungal medicines in the 4 weeks before joining.
  • You have taken probiotic supplements in the 4 weeks before joining.
  • You have had a known infection with certain bacteria (C. difficile or E. coli) in the 10 days before joining.
  • You have another serious or unstable health condition that could interfere with the study, according to the doctor's judgment.
  • You have previously received a fecal microbiota transplant (a treatment involving donor gut bacteria).
  • You have a medical reason why you cannot take the bowel preparation medicine used in this study (confirm with trial site).
  • You have a current or past history of bowel blockage.
  • You have confirmed or suspected reduced blood supply to the intestines.
  • You have confirmed or suspected severe bowel complications such as toxic megacolon or a hole in the bowel.
  • More than two-thirds of your colon has been surgically removed.
  • You have had any gastrointestinal bleeding in the 3 months before joining.
  • You have had any bowel surgery in the 3 months before joining.
  • You have severe dysfunction of a major organ (such as the liver or kidneys) (confirm with trial site).
  • You are unable to swallow capsules.
  • You have a known allergy or intolerance to the study treatment or its ingredients.
  • You do not have access to a refrigerator to store the study medication at home.
  • You are currently taking part in another clinical trial involving a treatment or intervention.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Maxime Breban, MD, PhD, Rheumatology Department - Ambroise Paré hospital - APHP

Phone: +33 0149095674

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
28 March 2024
Est. completion
1 September 2027

Where this trial is recruiting

🇫🇷 France

Primary endpoints

Increase in gut Metagenome Species Pangenome (MSP) richness in the "intervention" arm.; The proportion of patients satisfying ASAS 20 improvement criteria by randomization group

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov