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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05492578




Registration number
NCT05492578
Ethics application status
Date submitted
5/08/2022
Date registered
8/08/2022

Titles & IDs
Public title
Long-Term Safety and Efficacy Evaluation of Amlitelimab in Participants of Previous Amlitelimab Moderate to Severe Atopic Dermatitis Clinical Trials
Scientific title
A Long-term Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Subcutaneous Amlitelimab in Participants of Previous Amlitelimab Clinical Trials in Moderate to Severe Atopic Dermatitis.
Secondary ID [1] 0 0
U1111-1269-6490
Secondary ID [2] 0 0
LTS17367
Universal Trial Number (UTN)
Trial acronym
RIVER-AD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dermatitis Atopic 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Amlitelimab
Treatment: Drugs - Topical corticosteroids
Treatment: Drugs - Topical calcineurin inhibitors
Treatment: Drugs - Oral corticosteroids

Experimental: Amlitelimab - Subcutaneous injection


Treatment: Drugs: Amlitelimab
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Treatment: Drugs: Topical corticosteroids
Pharmaceutical form: Topical Route of administration: Topical

Treatment: Drugs: Topical calcineurin inhibitors
Pharmaceutical form: Topical Route of administration: Topical

Treatment: Drugs: Oral corticosteroids
Pharmaceutical form: Oral Route of administration: Oral
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of participants who experienced treatment-emergent adverse event (TEAE)
Timepoint [1] 0 0
Baseline to Week 332
Secondary outcome [1] 0 0
Percentage of participants who experienced treatment-emergent serious adverse events (SAEs)
Timepoint [1] 0 0
Baseline to Week 332
Secondary outcome [2] 0 0
Percentage of participants who experienced treatment-emergent adverse events of special interest (AESI)
Timepoint [2] 0 0
Baseline to Week 332
Secondary outcome [3] 0 0
Percentage of participants who experienced TEAE leading to treatment discontinuation
Timepoint [3] 0 0
Baseline to Week 332
Secondary outcome [4] 0 0
Absolute change from DRI17366 baseline in EASI score at each LTS17367 visit in participants entering the study from DRI17366 Week 24
Timepoint [4] 0 0
DRI17366 Baseline to Week 332
Secondary outcome [5] 0 0
Percent change from DRI17366 baseline in EASI score at each LTS17367 visit in participants entering the study from DRI17366 Week 24
Timepoint [5] 0 0
DRI17366 Baseline to Week 332
Secondary outcome [6] 0 0
Proportion of participants with EASI75/EASI90/EASI100 from DRI17366 baseline at each LTS17367 visit in participants entering the study from DRI17366 Week 24
Timepoint [6] 0 0
DRI17366 Baseline to Week 332
Secondary outcome [7] 0 0
Proportion of participants with a response of validated investigator global assessment scale for atopic dermatitis (vIGA-AD) 0 or 1 at each LTS17367 visit in participants entering the study from DRI17366 Week 24
Timepoint [7] 0 0
Baseline to Week 332
Secondary outcome [8] 0 0
Proportion of participants with vIGA-AD 0 or 1 with presence of only barely perceptible erythema (no induration/papulation, no lichenification, no oozing or crusting) at each LTS17367 visit
Timepoint [8] 0 0
Baseline to Week 332
Secondary outcome [9] 0 0
Absolute change from feeder study baseline in EASI score at pre-specified timepoints in all participants entering the study
Timepoint [9] 0 0
Baseline to Week 332
Secondary outcome [10] 0 0
Percent change from feeder study baseline in EASI score at pre-specified timepoints in all participants entering the study
Timepoint [10] 0 0
Baseline to Week 332
Secondary outcome [11] 0 0
Proportion of participants with EASI50/EASI75/EASI90/EASI100 at pre-specified timepoints in all participants entering the study
Timepoint [11] 0 0
Baseline to Week 332
Secondary outcome [12] 0 0
Time to first EASI75/EASI90/EASI100 in those participants who had not achieved it by the time of LTS17367 baseline in all participants entering the study
Timepoint [12] 0 0
Baseline to Week 332
Secondary outcome [13] 0 0
Time to first loss of EASI75 in those participants who were EASI75 at baseline of LTS17367 coming from EFC17600 and EFC17599
Timepoint [13] 0 0
Baseline to Week 332
Secondary outcome [14] 0 0
Time to first loss of vIGA-AD 0/1 in those participants who were vIGA-AD 0/1 at baseline of LTS17367 coming from EFC17600 and EFC17599
Timepoint [14] 0 0
Baseline to Week 332
Secondary outcome [15] 0 0
Time to recapture response in those participants who were responders at baseline of LTS17367 with relapse during LTS17367 coming from EFC17600 and EFC17599
Timepoint [15] 0 0
Baseline to Week 332
Secondary outcome [16] 0 0
Time to first remission after LTS17367 enrollment (achieving vIGA-AD 0/1) in those participants who had not achieved vIGA-AD 0/1 by the time of LTS17367 entry in all participants entering the study
Timepoint [16] 0 0
Baseline to Week 332
Secondary outcome [17] 0 0
Proportion of participants with vIGA-AD score 0/1 at each visit in all participants entering the study
Timepoint [17] 0 0
Baseline to Week 332
Secondary outcome [18] 0 0
Proportion of participants with low disease activity state (e.g., vIGA-AD <2) at each visit in all participants entering the study
Timepoint [18] 0 0
Baseline to Week 332
Secondary outcome [19] 0 0
Proportion of participants requiring rescue treatment at each visit: all treatments in all participants entering the study
Timepoint [19] 0 0
Baseline to Week 332
Secondary outcome [20] 0 0
Proportion of participants requiring topical treatment at each visit in all participants entering the study
Timepoint [20] 0 0
Baseline to Week 332
Secondary outcome [21] 0 0
Proportion of participants requiring rescue treatment at each visit: systematic treatments in all participants entering the study
Timepoint [21] 0 0
Baseline to Week 332
Secondary outcome [22] 0 0
Number of days on topical medication (per patient-year) in all participants entering the study
Timepoint [22] 0 0
Baseline to Week 332
Secondary outcome [23] 0 0
Change from feeder study baseline to prespecified time points through the end of the study: atopic dermatitis control tool (ADCT) in all participants entering the study
Timepoint [23] 0 0
Baseline to Week 332
Secondary outcome [24] 0 0
Change from feeder study baseline to prespecified time points through the end of the study in dermatology life quality index or children's DLQI (DLQI/cDLQI) in all participants entering the study
Timepoint [24] 0 0
Baseline to Week 332
Secondary outcome [25] 0 0
Change from feeder study baseline to prespecified time points through the end of the study in patient oriented eczema measure (POEM) in all participants entering the study
Timepoint [25] 0 0
Baseline to Week 332
Secondary outcome [26] 0 0
Change from feeder study baseline in body surface area affected by AD (BSA-AD)
Timepoint [26] 0 0
Baseline to Week 332
Secondary outcome [27] 0 0
Serum amlitelimab concentration assessed at prespecified time points through the end of the study
Timepoint [27] 0 0
Baseline to Week 332
Secondary outcome [28] 0 0
Number of participants with anti drug antibodies (ADAs) of amlitelimab
Timepoint [28] 0 0
Baseline to Week 332

Eligibility
Key inclusion criteria
* Participant must be at least 12 years of age at the time of signing the informed consent.
* Participated in an amlitelimab clinical trial for moderate to severe AD and received study treatment, adequately completed the assessments required for the treatment period.

* Have reached the rollover timepoint to LTS17367 at the last visit of the treatment period of their feeder study SFY17915, INT18404, EFC17599, or EFC17600
* Participants in DRI17366 must only be enrolled from 1 of the following 3 groups:

* The first group: participants at Week 24 in the DRI17336 study who have not achieved an = Eczema Area and Skin Severity Index (EASI)-75 and are Investigator Global Assessment (IGA) = 2.
* The second group: participants entering LTS17367 between Week 28 and Week 52 of the feeder study, due to loss of clinical response in the part 2 of the feeder study. Timepoints for entering LTS17367 are Weeks 28, 32, 36, 40, 44, 48 or 52.
* The third group: participants at Week 24 in DRI17366 who have been re-randomized and who subsequently complete the study to Week 52, enter safety follow-up and experience worsening of their AD during safety follow-up.
* Participated in DRI17366 completing the previous study safety follow up (week 68) and wish to re-initiate treatment with amlitelimab up to one year after the last visit
* Complied with the previous clinical trial protocol to the satisfaction of the investigator
* Body weight must be =25 kg
* Provide signed informed assent/or consent and able to comply with the requirements of the protocol
Minimum age
12 Years
Maximum age
No limit
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:

* Developed a medical condition that would preclude participation as described in the permanent discontinuation
* Known history of or suspected current significant immunosuppression, including history of invasive opportunistic infections or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration
* History of solid organ or stem cell transplant
* Any malignancies or history of malignancies prior to baseline (except for non-melanoma skin cancer that has been excised and completely cured for more than 5 years prior to baseline)
* Participants positive for human immunodeficiency virus; participants with any of the following results at Screening (Visit 1) or at any point during the feeder study: presence of HBsAg with or without HBV DNA PCR test, or presence of anti-HBc Ab or presence of anti-HBs Ab with positive HBV DNA PCR test; positive HCVAb confirmed by positive HCV RNA
* History (within last 2 years prior to baseline) of prescription drug or substance abuse, including alcohol, considered significant by the Investigator
* Participants with active TB, latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, non-TB mycobacterial infection, or who are at high risk of contracting TB (such as close contact with individuals with active or latent TB) or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to screening
* Participants with an indeterminate or a confirmed positive IGRA test are excluded from the study unless all of the following conditions are met:

1. Have a history of prior documented completed chemoprophylaxis for latent TB infection (with a treatment regimen as per local guidelines), OR treated for active TB infection
2. Have been in written form approved for participation in the present trial by a TB specialist who ruled out latent or active TB infection or other mycobacterial infection in the participant
3. For whom review and approval from Sponsor have been granted are eligible
* Severe concomitant illness that would in the Investigator's opinion inhibit the patient's participation in the study, including for example, but not limited to, hypertension, renal disease, neurological conditions, heart failure and pulmonary disease
* Skin co-morbidity that would adversely affect the ability to undertake AD assessments (e.g., psoriasis, tinea corporis, lupus erythematosus) as per Investigator's judgment
* Any medical or psychiatric condition which, in the opinion of the Investigator may present an unreasonable risk to the study patient as a result of his/her participation in this clinical study, may make patient's participation unreliable, or may interfere with study assessments
* In the Investigator's opinion, medical conditions related to prior AD medications that have not healed/fully recovered for more than 2 weeks before screening visit, including, but not limited to, conjunctivitis, keratitis, eosinophilic conditions, arthralgia, herpes zoster, thrombosis

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
NA
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
22/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/12/2028
Actual
Sample size
Target
1310
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Investigational Site Number : 0363002 - Carlton
Recruitment hospital [2] 0 0
Investigational Site Number : 0363003 - East Melbourne
Recruitment hospital [3] 0 0
Investigational Site Number : 0363001 - Parkville
Recruitment postcode(s) [1] 0 0
3053 - Carlton
Recruitment postcode(s) [2] 0 0
3002 - East Melbourne
Recruitment postcode(s) [3] 0 0
3050 - Parkville
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
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Louisiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Oklahoma
Country [7] 0 0
United States of America
State/province [7] 0 0
Tennessee
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
Bulgaria
State/province [9] 0 0
Pleven
Country [10] 0 0
Bulgaria
State/province [10] 0 0
Sofia
Country [11] 0 0
Canada
State/province [11] 0 0
Alberta
Country [12] 0 0
Canada
State/province [12] 0 0
Ontario
Country [13] 0 0
Czechia
State/province [13] 0 0
Brno
Country [14] 0 0
Czechia
State/province [14] 0 0
Kutna Hora
Country [15] 0 0
Czechia
State/province [15] 0 0
Ostrava
Country [16] 0 0
Czechia
State/province [16] 0 0
Praha 10
Country [17] 0 0
Czechia
State/province [17] 0 0
Praha 2
Country [18] 0 0
Czechia
State/province [18] 0 0
Praha 3
Country [19] 0 0
Germany
State/province [19] 0 0
Berlin
Country [20] 0 0
Germany
State/province [20] 0 0
Blankenfelde-Mahlow
Country [21] 0 0
Germany
State/province [21] 0 0
Gera
Country [22] 0 0
Germany
State/province [22] 0 0
Kiel
Country [23] 0 0
Germany
State/province [23] 0 0
Münster
Country [24] 0 0
Hungary
State/province [24] 0 0
Debrecen
Country [25] 0 0
Hungary
State/province [25] 0 0
Gyula
Country [26] 0 0
Hungary
State/province [26] 0 0
Szolnok
Country [27] 0 0
Japan
State/province [27] 0 0
Hokkaido
Country [28] 0 0
Japan
State/province [28] 0 0
Kagoshima
Country [29] 0 0
Japan
State/province [29] 0 0
Kanagawa
Country [30] 0 0
Japan
State/province [30] 0 0
Osaka
Country [31] 0 0
Japan
State/province [31] 0 0
Tochigi
Country [32] 0 0
Japan
State/province [32] 0 0
Tokyo
Country [33] 0 0
Japan
State/province [33] 0 0
Habikino-shi
Country [34] 0 0
Japan
State/province [34] 0 0
Kyoto-shi
Country [35] 0 0
Poland
State/province [35] 0 0
Dolnoslaskie
Country [36] 0 0
Poland
State/province [36] 0 0
Lódzkie
Country [37] 0 0
Poland
State/province [37] 0 0
Malopolskie
Country [38] 0 0
Poland
State/province [38] 0 0
Mazowieckie
Country [39] 0 0
Poland
State/province [39] 0 0
Podkarpackie
Country [40] 0 0
Poland
State/province [40] 0 0
Podlaskie
Country [41] 0 0
Poland
State/province [41] 0 0
Pomorskie
Country [42] 0 0
Poland
State/province [42] 0 0
Slaskie
Country [43] 0 0
Poland
State/province [43] 0 0
Zachodniopomorskie
Country [44] 0 0
Poland
State/province [44] 0 0
Krakow
Country [45] 0 0
Spain
State/province [45] 0 0
Galicia [Galicia]
Country [46] 0 0
Spain
State/province [46] 0 0
Madrid, Comunidad De
Country [47] 0 0
Spain
State/province [47] 0 0
Alicante
Country [48] 0 0
Spain
State/province [48] 0 0
Córdoba
Country [49] 0 0
Taiwan
State/province [49] 0 0
Kaohsiung Hsien,
Country [50] 0 0
Taiwan
State/province [50] 0 0
Taichung
Country [51] 0 0
Taiwan
State/province [51] 0 0
Tao Yuan County
Country [52] 0 0
United Kingdom
State/province [52] 0 0
London, City Of

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 number for US & Canada)
Address 0 0
Country 0 0
Phone 0 0
800-633-1610
Fax 0 0
Email 0 0
contact-us@sanofi.com
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/NCT05492578