Clinical trial • Phase III • Gastroenterology

ALLOGENEIC FAECAL MICROBIOTA, POOLED for Crohn's disease

Phase III trial of ALLOGENEIC FAECAL MICROBIOTA, POOLED for Crohn's disease.

Overview

Trial Therapeutic Area
Gastroenterology
Trial Disease
Crohn's disease
Trial Stage
Phase III
Drug Modality
Other

Key dates

Initial CTIS Submission Date
14-10-2024
First CTIS Authorization Date
29-10-2024

Trial design

Randomised, sham transplantation (placebo): placebo double encapsulated oral transplant of fecal microbiota (product: placebo double encapsulated oral transplant of fecal microbiota; route oral; max daily dose 12 g; max total dose 24 g; max treatment period 2 [time unit days]) and placebo coloscopic transplant of fecal microbiota (product: placebo coloscopic transplant of fecal microbiota; route rectal use; max daily dose 330 ml; max total dose 330 ml; max treatment period 1).-controlled Phase III trial across 16 sites in France.

Randomised
Yes
Comparator
Sham transplantation (placebo): Placebo double encapsulated oral transplant of fecal microbiota (product: Placebo double encapsulated oral transplant of fecal microbiota; route ORAL; max daily dose 12 g; max total dose 24 g; max treatment period 2 [time unit days]) and Placebo coloscopic transplant of Fecal microbiota (product: Placebo coloscopic transplant of Fecal microbiota; route RECTAL USE; max daily dose 330 ml; max total dose 330 ml; max treatment period 1).
Target Sample Size
350
Trial Duration For Participant
364

Eligibility

Recruits 350 Vulnerable population not selected. Only adults (Age ≥ 18 years and < 75 years) are eligible. Informed written consent is required from participants. Healthy volunteer donors have separate volunteer consent documentation. No assent procedures for minors are applicable (minors are excluded)..

Pregnancy Exclusion
Pregnancy or breastfeeding during the study
Vulnerable Population
Vulnerable population not selected. Only adults (Age ≥ 18 years and < 75 years) are eligible. Informed written consent is required from participants. Healthy volunteer donors have separate volunteer consent documentation. No assent procedures for minors are applicable (minors are excluded).

Inclusion criteria

  • {"criterion_text":"- Age ≥ 18 years and < 75 years\n- Crohn’s disease (according to the Lennard-Jones criteria) for at least 6 months\n- Patient in steroid-free clinical remission for at least 6 months under anti-TNF agent (no clinical evidence of flare nor change in Crohn’s disease specific treatment (anti-TNF, immunosuppressive, …) within 6 months before inclusion) and CDAI <150 the week before inclusion) and willing to withdraw anti-TNF treatment\n- Female of child-bearing age with an active contraception and this during at least the period of treatment\n- Patient with health insurance\n- Informed Written consent\n- Healthy volunteers donors :Regular bowel movement defined as at least 1 stool every other day and maximum 2 stools per day"}

Exclusion criteria

  • {"criterion_text":"- Crohn’s Disease complication requiring surgical treatment\n- Contraindication to colonoscopy or anesthesia\n- Pregnancy or breastfeeding during the study\n- Diagnosis of Crohn’s disease restricted to the upper gastrointestinal tract (oesophagus, stomac, duodenum, jejunum)\n- Patient with active perineal disease (defined as evidence of perineal abscess or active draining fistula or presence of seton or presence of perineal ulceration)\n- History of more than one small bowel resection or small intestine resection > 1 meter\n- Current stoma (Ileostomy or a colostomy) or stoma in the last 6 months or any other intra-abdominal surgery within 3 months prior to inclusion."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Clinical remission (defined by a CDAI <150) at week 52 (V8) without any flare between week 0 (colonoscopy (V2)) and week 52 (V8). Flare is defined by a CDAI (Addendum 2) above 250 or between 150 points and 250 points with a 70-point increase from baseline (v0 : inclusion) over 2 consecutive weeks and the need to start any new treatment for CD.","definition_or_measurement_approach":"Clinical remission defined by CDAI <150 at week 52; flare defined as CDAI >250 or CDAI 150–250 with a 70-point increase from baseline over 2 consecutive weeks and need to start new treatment."}

Secondary endpoints

  • {"endpoint_text":"- Relapse free survival rate from week 0 (V2) to week 52 (V8)","definition_or_measurement_approach":"Time-to-event analysis of relapse-free survival between week 0 and week 52."}
  • {"endpoint_text":"- Proportion of endoscopic remission (SES-CD ≤2) at week 52 (V8) and change (in %) in endoscopic score (SES-CD) between week 0 (V2) and 52 (V8)","definition_or_measurement_approach":"Endoscopic remission defined as SES-CD ≤2; percent change in SES-CD between week 0 and week 52."}
  • {"endpoint_text":"- Clinical remission defined by a CDAI < 150 at week 52; endoscopic remission defined by a SES-CD ≤ 2.","definition_or_measurement_approach":"Clinical remission: CDAI <150 at week 52. Endoscopic remission: SES-CD ≤2 at week 52."}
  • {"endpoint_text":"- Measures of inflammation: blood cell count, CRP level, fecal calprotectin at week 6 (V3), 12 (V4), 24 (V5), 36 (V6), 48 (V7) and 52 (V8)","definition_or_measurement_approach":"Serial laboratory measurements: full blood counts, CRP, and fecal calprotectin at specified visits (weeks 6, 12, 24, 36, 48, 52)."}
  • {"endpoint_text":"- Microbiota composition and diversity using 16s sequencing technology at week 6 (V3), 12 (V4), 24 (V5), 36 (V6), 48 (V7) and 52 (V8)","definition_or_measurement_approach":"Assessment of intestinal microbiota composition and diversity by 16S sequencing at specified visits (weeks 6, 12, 24, 36, 48, 52)."}

Recruitment

Planned Sample Size
350
Recruitment Window Months
70
Consent Approach
Informed written consent is required. Subject information and informed consent forms are available (adult and volunteer-specific ICFs). Healthy volunteer donors have separate volunteer consent documentation. Consent is obtained from adult participants; no minors or assent procedures are applicable.

Geography

Total Number Of Sites
16
Total Number Of Participants
350

France

Earliest CTIS Part Ii Submission Date
22-10-2024
Latest Decision Or Authorization Date
15-07-2025
Processing Time Days
266
Number Of Sites
16
Number Of Participants
350

Sites

Site Name
Hospices Civils De Lyon
Department Name
Gastro-enterology
Contact Person Name
Stéphane NANCEY
Contact Person Email
stephane.nancey@chu-lyon.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Gastro-enterology
Contact Person Name
Mathieu UZZAN
Contact Person Email
mathieu.uzzan@aphp.fr
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Gastro-enterology
Contact Person Name
Guillaume BOUGUEN
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Gastro-enterology
Contact Person Name
Joelle bONNET
Contact Person Email
joelle.bonnet@aphp.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Gastro-enterology
Contact Person Name
Stéphane SCHNEIDER
Contact Person Email
stephane.Schneider@unice.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Gigestive Gastro-enterology
Contact Person Name
Laurent ALRIC
Contact Person Email
alric.l@chu-toulouse.fr
Site Name
Hopital Saint Antoine
Department Name
LRIPH
Contact Person Name
Laurence BERARD
Contact Person Email
laurence.berard@aphp.Fr
Site Name
Hopital Saint Antoine
Contact Person Name
Harry SOKOL
Contact Person Email
harry.sokol@aphp.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Gastro-enterology
Contact Person Name
Romain ALTWEGG
Contact Person Email
r-altwegg@chu-montpellier.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Gastro-enterology
Contact Person Name
Caroline TRANG
Contact Person Email
caroline.trang@chu-nantes.fr
Site Name
Hopital Saint Antoine
Department Name
FMT reference center (Gastro-enterology)
Contact Person Name
Harry SOKOL
Contact Person Email
harry.sokol@aphp.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Gastro-enterology
Contact Person Name
Frank CARBONNEL
Contact Person Email
franck.carbonnel@aphp.fr
Site Name
University Hospital Of Clermont-Ferrand
Department Name
Gastro-enterology
Contact Person Name
Anthony BUISSON
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Gastro-enterology and nutrition
Contact Person Name
Cyrielle GILLETTA
Contact Person Email
gilletta.c@chu-toulouse.fr
Site Name
Hopital Haut Leveque
Department Name
Hépatho-Gastroentérologie et Nutrition
Contact Person Name
David LAHARIE
Contact Person Email
david.laharie@chu-bordeaux.fr
Site Name
Centre Hospitalier Universitaire De Caen Normandie
Department Name
Gastro-enterology
Contact Person Name
Cléa ROUILLON
Contact Person Email
Rouillon-cl@chu-caen.fr

Sponsor

Primary sponsor

Full Name
Assistance Publique Hopitaux De Paris
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
Enema transplant of fecal microbiota
Active Substance
ALLOGENEIC FAECAL MICROBIOTA, POOLED
Modality
Other
Routes Of Administration
RECTAL USE
Route
RECTAL USE
Authorisation Status
Authorised
Maximum Dose
330 ml
Investigational Product Name
Double encapsulated oral transplant of fecal microbiota
Active Substance
ALLOGENEIC FAECAL MICROBIOTA, POOLED
Modality
Other
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised
Maximum Dose
24 g (max total); max daily 12 g
Investigational Product Name
Placebo double encapsulated oral transplant of fecal microbiota
Active Substance
PLACEBO
Modality
Other
Routes Of Administration
ORAL USE
Route
ORAL
Authorisation Status
Authorised
Maximum Dose
24 g (max total); max daily 12 g
Investigational Product Name
Placebo coloscopic transplant of Fecal microbiota
Active Substance
PLACEBO
Modality
Other
Routes Of Administration
RECTAL USE
Route
RECTAL USE
Authorisation Status
Authorised
Maximum Dose
330 ml

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