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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06557772




Registration number
NCT06557772
Ethics application status
Date submitted
14/08/2024
Date registered
16/08/2024

Titles & IDs
Public title
A Phase 2a/b Study of the Efficacy and Safety of Subcutaneous Amlitelimab in Adults With Nonresponsive Celiac Disease
Scientific title
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
Secondary ID [1] 0 0
2024-511213-38
Secondary ID [2] 0 0
DRI17963
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coeliac Disease 0 0
Celiac Disease 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Amlitelimab
Treatment: Drugs - Placebo
Treatment: Other - SIGE
Treatment: Other - Gluten-free product (GFP)

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


Treatment: Drugs: Amlitelimab
Pharmaceutical form: Injection solution Route of administration: SC injection

Treatment: Drugs: Placebo
Pharmaceutical form: Injection solution Route of administration: SC injection

Treatment: Other: SIGE
Pharmaceutical form: Capsule Route of administration: Oral

Treatment: Other: Gluten-free product (GFP)
Pharmaceutical form: Capsule Route of administration: Oral
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Villus Height to Crypt Depth Ratio (Vh:Cd) from baseline to Week 28
Timepoint [1] 0 0
Baseline to Week 28
Secondary outcome [1] 0 0
Change in Celiac Disease Symptom Diary (CDSD) Gastrointestinal (GI) symptom severity score
Timepoint [1] 0 0
Baseline to Week 28
Secondary outcome [2] 0 0
Percentage of participants who experienced treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs) and adverse events of special interest (AESI)
Timepoint [2] 0 0
Baseline to Week 44
Secondary outcome [3] 0 0
Percentage of participants with potentially clinically significant abnormalities (PCSA) for vital signs and clinical laboratory assessments
Timepoint [3] 0 0
Baseline to Week 44
Secondary outcome [4] 0 0
Percentage of participants discontinued from study treatment due to TEAEs
Timepoint [4] 0 0
Baseline to Week 44
Secondary outcome [5] 0 0
Serum amlitelimab concentrations measured at prespecified timepoints
Timepoint [5] 0 0
Baseline to Week 28
Secondary outcome [6] 0 0
Incidence of antidrug antibodies (ADAs) of amlitelimab
Timepoint [6] 0 0
Baseline to Week 44

Eligibility
Key inclusion criteria
* 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. 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).
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants are excluded from the study if any of the following criteria apply:

* A diagnosis of any severe complication of celiac disease, such as refractory celiac disease type 1 (RCD I) requiring immune suppressive medication, or type 2 (RCD II), enteropathy associated T-cell lymphoma (EATL), ulcerative jejunitis, or recent (within 12 months of screening) GI perforation.
* Presence of other active inflammatory GI disorders, including but not limited to the following: inflammatory bowel disease, eosinophilic esophagitis, diverticulitis, helicobacter infection, gastroenteritis or colitis, and microscopic colitis (requiring treatment) in the 6 months before screening. A history of treated erosive esophagitis is not an exclusion. Abnormalities found during baseline EGD or biopsy that are consistent with an inflammatory GI disorder other than celiac disease are exclusionary.
* Presence of other systemic autoimmune diseases including scleroderma, psoriatic or rheumatoid arthritis, and lupus. Participants with thyroid disease that has been well-controlled for at least 6 months, prior to screening, and participants with well-controlled type 1 diabetes (glycosylated hemoglobin < 9 % and no hospitalization or emergency room visit in the last 12 months for hyperglycemia or hypoglycemia) can be included per investigator judgement.
* Known or suspected severe enteric infection (viral, bacterial, or parasitic) within 6 months before screening. Severe enteric infection is defined as requiring a visit to the emergency room, hospitalization, or treatment with antibiotics or anti-infectives due to infection. Non-enteric viral infections, either resolved or well-controlled are not exclusionary.
* Any active or chronic infection including helminthic infection requiring systemic treatment within 4 weeks prior to screening (1 week in the event of superficial skin infections).
* Known history of or suspected significant current immunosuppression or hyposplenism, including history of invasive opportunistic or invasive helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
* Any malignancies or history of malignancies prior to enrollment (except for non-melanoma skin cancer that has been excised and completely cured for more than 5 years prior to enrollment).
* History of solid organ or stem cell transplant.
* Ongoing use, or use in the 3 months before screening, of medications known to cause villus abnormalities (eg, mycophenolate mofetil, azathioprine, methotrexate, olmesartan (other angiotensin receptor blockers are allowed), CTLA4 inhibitors, and PD-1/PD-L1 inhibitors).
* Ongoing chronic use of non-steroidal anti-inflammatory drugs (NSAIDs) of more than 2 doses per week, except acetylsalicylic acid/aspirin =100 mg daily for prophylactic use.
* Any ongoing treatment with systemic immunosuppressants, systemic corticosteroids, or use of oral budesonide in the 12 weeks before screening.
* Ongoing use of over-the-counter digestive enzymes or supplements, other than lactase, including those for gluten digestion and oral pharmaceutical probiotic supplements. Probiotics in foods (e.g., yogurt) are permitted.
* Concurrent participation in any other clinical study, including non-interventional studies.
* Prior administration of investigational agents to treat celiac disease within 5 half-lives of any agent, or one year from any tolerogenic agent.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/08/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
10/04/2029
Actual
Sample size
Target
204
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Investigational Site Number : 0360001 - Mackay
Recruitment hospital [2] 0 0
Investigational Site Number : 0360005 - Melbourne
Recruitment postcode(s) [1] 0 0
4740 - Mackay
Recruitment postcode(s) [2] 0 0
3128 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Idaho
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
Rhode Island
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Utah
Country [11] 0 0
United States of America
State/province [11] 0 0
Virginia
Country [12] 0 0
Argentina
State/province [12] 0 0
Ciudad De Buenos Aires
Country [13] 0 0
Argentina
State/province [13] 0 0
Buenos Aires
Country [14] 0 0
Belgium
State/province [14] 0 0
Leuven
Country [15] 0 0
Canada
State/province [15] 0 0
British Columbia
Country [16] 0 0
Chile
State/province [16] 0 0
Reg Metropolitana De Santiago
Country [17] 0 0
Chile
State/province [17] 0 0
Santiago
Country [18] 0 0
Chile
State/province [18] 0 0
Talcahuano
Country [19] 0 0
Czechia
State/province [19] 0 0
Havirov
Country [20] 0 0
Czechia
State/province [20] 0 0
Klatovy
Country [21] 0 0
Czechia
State/province [21] 0 0
Prague
Country [22] 0 0
Finland
State/province [22] 0 0
Helsinki
Country [23] 0 0
Finland
State/province [23] 0 0
Tampere
Country [24] 0 0
Finland
State/province [24] 0 0
Turku
Country [25] 0 0
France
State/province [25] 0 0
Nice
Country [26] 0 0
France
State/province [26] 0 0
Paris
Country [27] 0 0
Greece
State/province [27] 0 0
Athens
Country [28] 0 0
Israel
State/province [28] 0 0
Jerusalem
Country [29] 0 0
Israel
State/province [29] 0 0
Rehovot
Country [30] 0 0
Italy
State/province [30] 0 0
Milan
Country [31] 0 0
Italy
State/province [31] 0 0
Pisa
Country [32] 0 0
Poland
State/province [32] 0 0
Dolnoslaskie
Country [33] 0 0
Poland
State/province [33] 0 0
Malopolskie
Country [34] 0 0
Poland
State/province [34] 0 0
Poznan
Country [35] 0 0
Poland
State/province [35] 0 0
Warsaw
Country [36] 0 0
Slovakia
State/province [36] 0 0
Košice
Country [37] 0 0
Spain
State/province [37] 0 0
Barcelona [Barcelona]
Country [38] 0 0
Spain
State/province [38] 0 0
Sevilla
Country [39] 0 0
Spain
State/province [39] 0 0
Chiclana de La Frontera
Country [40] 0 0
Spain
State/province [40] 0 0
Madrid
Country [41] 0 0
Spain
State/province [41] 0 0
Málaga
Country [42] 0 0
Sweden
State/province [42] 0 0
Linköping
Country [43] 0 0
Sweden
State/province [43] 0 0
Mölndal
Country [44] 0 0
Sweden
State/province [44] 0 0
Stockholm
Country [45] 0 0
Sweden
State/province [45] 0 0
Uppsala
Country [46] 0 0
Turkey
State/province [46] 0 0
Akdeniz
Country [47] 0 0
Turkey
State/province [47] 0 0
Antalya
Country [48] 0 0
Turkey
State/province [48] 0 0
Gaziantep
Country [49] 0 0
Turkey
State/province [49] 0 0
Istanbul
Country [50] 0 0
Turkey
State/province [50] 0 0
Sanliurfa
Country [51] 0 0
Turkey
State/province [51] 0 0
Zonguldak
Country [52] 0 0
United Kingdom
State/province [52] 0 0
Oxfordshire
Country [53] 0 0
United Kingdom
State/province [53] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Trial Transparency email recommended (Toll free for US & Canada)
Address 0 0
Country 0 0
Phone 0 0
800-633-1610
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06557772