A Phase 2a/b, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of Subcutaneous Amlitelimab in Adult Patients With Nonresponsive Celiac Disease as an Adjunct to a Gluten-free Diet

Status: Recruiting
Location: See all (106) locations...
Intervention Type: Drug, Dietary supplement
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a Phase 2a/b, randomized, double-blind, placebo-controlled, parallel-group, 6-arm study to evaluate the efficacy and safety of amlitelimab in adult participants with non-responsive celiac disease (NRCD) who are on a gluten free diet (GFD) with and without simulated inadvertent gluten exposure (SIGE). The primary purpose of this study is to demonstrate the efficacy of subcutaneous (SC) amlitelimab in male and female participants (aged 18 to 75 years, inclusive) with NRCD. The study will assess the effect of amlitelimab when compared to placebo on gluten induced changes in the intestinal mucosa as measured by the villous height to crypt depth (Vh:Cd) ratio. The effect of amlitelimab on participant-reported celiac signs and symptoms along with the safety, tolerability, and pharmacokinetics of amlitelimab will also be studied. Study details include: The study duration will be up to 48 weeks (including a 16-week safety follow-up period) with 10 visits for participants who opt not to enter the optional long-term extension. The study duration will be up to 172 weeks (including an 8-week safety follow-up period) with 22 visits for participants who enter the optional long-term extension. The double-blind placebo-controlled treatment duration will be up to 28 weeks.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Participants must be 18 to 75 years of age inclusive, at the time of signing the informed consent.

• Participants with physician-diagnosed celiac disease with documented history of biopsy-proven celiac disease confirmed by medical records or physician statement.

• Participants who have self-reported attempt to maintain a GFD (and confirmed via questionnaire) for at least 12 consecutive months and must be willing to maintain their current diet for the duration of study participation.

• Participants have an adequate comprehension of a GFD as assessed by the Investigator.

• Participants willing to undergo all assessments in the protocol, including 2 esophagogastroduodenoscopies with duodenal biopsies.

• Participants who completed CDSD with ≥ 75% compliance from screening until randomization.

• During screening, participants must have at least one gastrointestinal symptom (i.e., diarrhea, abdominal pain, bloating, or nausea) of moderate or greater severity, as measured by the CDSD Gastrointestinal Domain, on at least 3 days out of any consecutive 7-day period considered by the investigator to be related to gluten exposure (i.e., due to celiac disease). The symptom can vary, but severity must be moderate or greater on three or more days. Participants must meet symptom criteria to undergo baseline esophagogastroduodenoscopy (EGD).

Locations
United States
California
FOMAT Medical Research - inSite Digestive Health Care - Arcadia- Site Number : 8400052
RECRUITING
Arcadia
Ventura County Gastroenterology Medical Group- Site Number : 8400010
RECRUITING
Camarillo
Om Research - Lancaster - 15th Street West- Site Number : 8400001
RECRUITING
Lancaster
United Gastroenterologists - Los Alamitos- Site Number : 8400014
RECRUITING
Los Alamitos
Colorado
Advanced Research Institute - Denver- Site Number : 8400048
RECRUITING
Denver
Florida
Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400040
RECRUITING
Miami Lakes
GI Pros- Site Number : 8400034
RECRUITING
Naples
GCP Clinical Research- Site Number : 8400007
RECRUITING
Tampa
Georgia
Archbold Memorial Hospital- Site Number : 8400044
RECRUITING
Thomasville
Kansas
Hutchinson Clinic- Site Number : 8400020
RECRUITING
Hutchinson
Massachusetts
Boston Specialists- Site Number : 8400051
RECRUITING
Boston
Berkshire Medical Center, Inc.- Site Number : 8400017
RECRUITING
Pittsfield
Michigan
Gastroenterology Associates of Western Michigan, P.L.C.- Site Number : 8400004
RECRUITING
Wyoming
Minnesota
Mayo Clinic Hospital Rochester- Site Number : 8400049
RECRUITING
Rochester
Missouri
Washington University- Site Number : 8400025
RECRUITING
St Louis
North Carolina
Ospedale Maggiore Policlinico Milano-Site Number : 3800002
RECRUITING
Charlotte
M3-Emerging Medical Research- Site Number : 8400008
RECRUITING
Raleigh
New Jersey
Sanmora Bespoke Clinical Research Solutions- Site Number : 8400015
RECRUITING
East Orange
Allied Health Clinical Research Organization, LLC- Site Number : 8400053
RECRUITING
Freehold
Nevada
Advanced Research Institute- Site Number : 8400036
RECRUITING
Reno
Rhode Island
Velocity Clinical Research - Providence- Site Number : 8400002
RECRUITING
East Greenwich
Tennessee
ClinSearch - Chattanooga - Shallowford Road- Site Number : 8400012
RECRUITING
Chattanooga
Quality Medical Research- Site Number : 8400018
RECRUITING
Nashville
Texas
Advanced Research Institute- Site Number : 8400030
RECRUITING
Cedar Park
MedCare Pharma - Houston - Cypress Creek Parkway- Site Number : 8400016
RECRUITING
Houston
LinQ Research, LLC- Site Number : 8400028
RECRUITING
Pearland
DM Clinical Research - Tomball- Site Number : 8400042
RECRUITING
Tomball
Utah
Advanced Research Institute - Sandy- Site Number : 8400046
RECRUITING
Sandy City
Velocity Clinical Research - Salt Lake City- Site Number : 8400023
RECRUITING
West Jordan
Virginia
Clinical Research Partners - Richmond - Forest Avenue- Site Number : 8400011
RECRUITING
Richmond
Washington
GI Alliance- Site Number : 8400033
RECRUITING
Tacoma
Other Locations
Argentina
Investigational Site Number : 0320001
RECRUITING
Buenos Aires
Investigational Site Number : 0320007
RECRUITING
Buenos Aires
Investigational Site Number : 0320003
RECRUITING
Córdoba
Investigational Site Number : 0320010
RECRUITING
Quilmes
Investigational Site Number : 0320005
RECRUITING
Rosario
Investigational Site Number : 0320008
RECRUITING
San Isidro
Investigational Site Number : 0320002
RECRUITING
San Miguel De Tucumán
Australia
Investigational Site Number : 0360001
RECRUITING
Mackay
Investigational Site Number : 0320012
RECRUITING
Maroochydore
Investigational Site Number : 0360005
ACTIVE_NOT_RECRUITING
Melbourne
Investigational Site Number : 0360002
RECRUITING
Sydney
Belgium
Investigational Site Number : 0560002
RECRUITING
Brussels
Investigational Site Number : 0560001
RECRUITING
Leuven
Brazil
Chronos Pesquisa Clínica- Site Number : 0760002
RECRUITING
Brasília
Hospital Moinhos de Vento- Site Number : 0760004
RECRUITING
Porto Alegre
Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760001
RECRUITING
Porto Alegre
Centro de Pesquisas da Clínica IBIS- Site Number : 0760006
RECRUITING
Salvador
Hospital Sao Rafael- Site Number : 0760005
RECRUITING
Salvador
Praxis Pesquisa Medica- Site Number : 0760008
RECRUITING
Santo André
Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 8400013
RECRUITING
Vitória
Canada
Investigational Site Number : 1240001
RECRUITING
Vancouver
Investigational Site Number : 1240002
RECRUITING
Victoria
Chile
Investigational Site Number : 1520006
RECRUITING
Concepción
Investigational Site Number : 1520001
RECRUITING
Santiago
Investigational Site Number : 1520004
RECRUITING
Santiago
Investigational Site Number : 1520007
RECRUITING
Santiago
Investigational Site Number : 1520005
RECRUITING
Talcahuano
Finland
Investigational Site Number : 2460002
RECRUITING
Helsinki
Investigational Site Number : 0320009
RECRUITING
Kuopio
Investigational Site Number : 2460003
RECRUITING
Tampere
Investigational Site Number : 2460001
RECRUITING
Turku
France
Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin Tripode- Site Number : 8400006
RECRUITING
Bordeaux
Investigational Site Number : 2500002
RECRUITING
Nice
Investigational Site Number : 2500001
RECRUITING
Paris
Germany
Investigational Site Number : 2760004
RECRUITING
Berlin
Investigational Site Number : 2760001
RECRUITING
Halle
Investigational Site Number : 2760002
RECRUITING
Mainz
Greece
Investigational Site Number : 3000001
RECRUITING
Athens
Investigational Site Number : 3000002
RECRUITING
Athens
Israel
Investigational Site Number : 3760002
RECRUITING
Afula
Investigational Site Number : 3760006
RECRUITING
Beersheba
Investigational Site Number : 3760004
RECRUITING
Jerusalem
Investigational Site Number : 3760003
RECRUITING
Petah Tikva
Investigational Site Number : 3760007
RECRUITING
Ramat Hasharon
Investigational Site Number : 3760001
RECRUITING
Rehovot
Italy
Azienda Ospedaliera di Padova-Site Number : 3800004
RECRUITING
Padua
Ospedale di Cisanello-Site Number : 3800003
RECRUITING
Pisa
Netherlands
Investigational Site Number : 5280001
RECRUITING
Amsterdam
Investigational Site Number : 5280002
RECRUITING
Arnhem
Poland
Investigational Site Number : 6160001
RECRUITING
Krakow
Investigational Site Number : 6160004
RECRUITING
Poznan
Investigational Site Number : 6160002
RECRUITING
Warsaw
Investigational Site Number : 6160005
RECRUITING
Wroclaw
Slovakia
Investigational Site Number : 7030001
RECRUITING
Košice
Investigational Site Number : 7030003
RECRUITING
Nitra
Investigational Site Number : 7030004
RECRUITING
Šahy
Spain
Investigational Site Number : 7240006
RECRUITING
Barcelona
Investigational Site Number : 7240009
RECRUITING
Chiclana De La Frontera
Investigational Site Number : 7240003
RECRUITING
Madrid
Investigational Site Number : 7240007
RECRUITING
Madrid
Investigational Site Number : 7240004
RECRUITING
Málaga
Investigational Site Number : 7240002
RECRUITING
Seville
Investigational Site Number : 7240008
RECRUITING
Seville
Sweden
Investigational Site Number : 7522001
RECRUITING
Linköping
Investigational Site Number : 7521001
RECRUITING
Mölndal
Investigational Site Number : 7520003
RECRUITING
Stockholm
Investigational Site Number : 7520001
RECRUITING
Uppsala
Turkey
Investigational Site Number : 7920004
RECRUITING
Antalya
Investigational Site Number : 7920003
RECRUITING
Gaziantep
Investigational Site Number : 7920006
RECRUITING
Istanbul
Investigational Site Number : 7920001
RECRUITING
Mersin
Investigational Site Number : 7920005
RECRUITING
Sanliurfa
Investigational Site Number : 7920002
RECRUITING
Zonguldak
United Kingdom
Investigational Site Number : 8260001
RECRUITING
Oxford
Investigational Site Number : 8260002
RECRUITING
Sheffield
Contact Information
Primary
Trial Transparency email recommended (Toll free for US & Canada)
contact-us@sanofi.com
800-633-1610
Time Frame
Start Date: 2024-08-29
Estimated Completion Date: 2029-04-10
Participants
Target number of participants: 204
Treatments
Experimental: Amlitelimab dose 1 + Gluten-free product (GFP)
Amlitelimab SC as per protocol + GFP
Experimental: Amlitelimab dose 2 + GFP
Amlitelimab SC as per protocol + GFP
Experimental: Amlitelimab dose 3 + GFP
Amlitelimab SC as per protocol + GFP
Experimental: Amlitelimab dose 1 + SIGE
Amlitelimab SC as per protocol + SIGE
Placebo_comparator: Placebo + GFP
Placebo SC as per protocol + GFP
Placebo_comparator: Placebo + SIGE
Placebo SC as per protocol + SIGE
Related Therapeutic Areas
Sponsors
Leads: Sanofi

This content was sourced from clinicaltrials.gov

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