NCT05492578
Enrolling by Invitation
Phase 2
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.
ConditionsDermatitis Atopic
Overview
- Phase
- Phase 2
- Intervention
- Topical corticosteroids
- Conditions
- Dermatitis Atopic
- Sponsor
- Sanofi
- Enrollment
- 1663
- Locations
- 651
- Primary Endpoint
- Percentage of participants who experienced treatment-emergent adverse event (TEAE)
- Status
- Enrolling by Invitation
- Last Updated
- 19 days ago
Overview
Brief Summary
This is an open-label, Phase 2/Phase 3, long-term extension study for treatment of participants of previous amlitelimab clinical trials in moderate to severe atopic dermatitis.
The purpose of this study is to characterize the safety and efficacy of amlitelimab in treated participants with moderate to severe atopic dermatitis (AD) who have previously been enrolled in an amlitelimab clinical trial. All participants will have visits during the treatment period every 4 weeks. Responder participants rolling over from EFC17599 and EFC17600, and responder participants enrolling through screening from DRI17366 will be initiated into drug withdrawal (with no drug administration) at LTS17367 baseline visit to monitor durability of treatment response. If these responder participants relapse during LTS17367, they will have treatment restored. Non-responder participants rolling over from EFC17599 or EFC17600, and non-responder participants enrolling through screening from DRI17366 will have treatment administration from LTS17367 baseline. Participants rolling over from DRI17366, SFY17915 and INT18404 will also have treatment administration from LTS17367 baseline.
Remote visits with home dosing are allowed for the purpose of study drug administration, when applicable. In the case of remote visit with home dosing, the participant or a caregiver may administer study drug after appropriate training. Alternatively, if needed, and based on the investigator's judgement, home visits with healthcare professional assistance or on-site study drug administration visits can be performed. Where participants discontinue amlitelimab permanently during LTS17367, safety follow up will be performed for a minimum of 140 days from the last amlitelimab administration.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participant must be at least 12 years of age inclusive 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) ≥
- •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
- •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
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 section for permanent discontinuation of the feeder study or LTS17367 protocol
- •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 (HIV); 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 PCR test
- •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:
- •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
Arms & Interventions
Amlitelimab dose level 2
Subcutaneous injection as per protocol
Intervention: Topical corticosteroids
Amlitelimab dose level 2
Subcutaneous injection as per protocol
Intervention: Oral corticosteroids
Amlitelimab dose level 1
Subcutaneous injection as per protocol
Intervention: Topical calcineurin inhibitors
Amlitelimab dose level 1
Subcutaneous injection as per protocol
Intervention: Oral corticosteroids
Amlitelimab dose level 2
Subcutaneous injection as per protocol
Intervention: Topical calcineurin inhibitors
Amlitelimab dose level 1
Subcutaneous injection as per protocol
Intervention: Topical corticosteroids
Amlitelimab dose level 1
Subcutaneous injection as per protocol
Intervention: Amlitelimab
Amlitelimab dose level 2
Subcutaneous injection as per protocol
Intervention: Amlitelimab
Outcomes
Primary Outcomes
Percentage of participants who experienced treatment-emergent adverse event (TEAE)
Time Frame: Baseline to Week 332
Secondary Outcomes
- Serum amlitelimab concentration assessed at prespecified time points through the end of the study(Baseline to Week 332)
- Number of participants with anti-drug antibodies (ADAs) of amlitelimab at specified timepoints(Baseline to Week 332)
- Proportion of participants requiring topical treatment in all participants entering the study [each LTS17367 visit](Baseline to Week 332)
- Proportion of participants requiring rescue treatment [each LTS17367 visit]: all treatments in all participants entering the study(Baseline to Week 332)
- Percentage of participants who experienced treatment-emergent serious adverse events (SAEs)(Baseline to Week 332)
- Percentage of participants who experienced treatment-emergent adverse events of special interest (AESI)(Baseline to Week 332)
- Percentage of participants who experienced TEAE leading to treatment discontinuation(Baseline to Week 332)
- Absolute change from DRI17366 baseline in EASI score at each LTS17367 visit in participants entering the study from DRI17366 Week 24(DRI17366 Baseline to Week 332)
- Percent change from DRI17366 baseline in EASI score at each LTS17367 visit in participants entering the study from DRI17366 Week 24(DRI17366 Baseline to Week 332)
- Time to first EASI75/EASI90 in those participants who had not achieved it by the time of LTS17367 enrollment(Baseline to Week 332)
- Number of days on topical medication (per patient-year) in all participants entering the study(Baseline to Week 332)
- Proportion of participants with EASI50/EASI75/EASI90/EASI100 from DRI17366 baseline at each LTS17367 visit in participants entering the study from DRI17366 Week 24(DRI17366 Baseline to Week 332)
- 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(Baseline to Week 332)
- Proportion of participants with vIGA-AD score 0/1 in all participants entering the study [each LTS17367 visit](Baseline to Week 332)
- Proportion of participants with vIGA-AD score 0 [each LTS17367 visit](Baseline to Week 332)
- Proportion of participants with vIGA-AD score 0 or 1 with presence of only barely perceptible erythema (no induration/papulation, no lichenification, no oozing or crusting) at each LTS17367 visit(Baseline to Week 332)
- Time to first vIGA-AD 0/1 after LTS17367 enrollment in those participants who had not achieved vIGA-AD 0/1 by the time of LTS17367 enrollment(Baseline to Week 332)
- Absolute change from feeder study baseline in EASI score in all participants entering the study [each LTS17367 visit](Baseline to Week 332)
- Percent change from feeder study baseline in EASI score in all participants entering the study [each LTS17367 visit](Baseline to Week 332)
- Proportion of participants with EASI50/EASI75/EASI90 in all participants entering the study [each LTS17367 visit](Baseline to Week 332)
- Change from feeder study baseline atopic dermatitis control tool (ADCT) in all participants entering the study [each LTS17367 visit](Baseline to Week 332)
- Change from feeder study baseline in dermatology life quality index (DLQI/cDLQI) in all participants entering the study [each LTS17367 visit](Baseline to Week 332)
- Change from feeder study baseline in patient oriented eczema measure (POEM) in all participants entering the study [each LTS17367 visit](Baseline to Week 332)
- Change from feeder study baseline in body surface area affected by AD (BSA-AD) [each LTS17367 visit](Baseline to Week 332)
- Time from enrollment in LTS17367 to first loss of vIGA-AD 0 in those participants who were vIGA-AD 0 at LTS17367 rollover from EFC17600 (ESTUARY) and EFC17599 (AQUA)(Baseline to Week 332)
- Time from enrollment in LTS17367 to first loss EASI75 in those participants who had reached EASI75 at LTS17367 rollover coming from EFC17600 (ESTUARY) and EFC17599 (AQUA)(Baseline to Week 332)
- Time from enrollment in LTS17367 to first loss of vIGA-AD 0/1 in those participants who were vIGA-AD 0/1 at LTS17367 rollover from EFC17600 (ESTUARY) and EFC17599 (AQUA)(Baseline to Week 332)
- Time from LTS17367 baseline to re-treatment with amlitelimab in those participants who were vIGA-AD 0/1 at LTS17367 rollover from EFC17600 (ESTUARY) and EFC17599 (AQUA)(Baseline to Week 332)
- Time from last amlitelimab dose in feeder study to re-treatment with amlitelimab in those participants who were vIGA-AD 0/1 at LTS17367 rollover from EFC17600 (ESTUARY) and EFC17599 (AQUA)(Baseline to Week 332)
- Percentage of participants who experienced treatment-emergent serious adverse events (SAEs)(Baseline to Week 332)
- Percentage of participants who experienced treatment-emergent adverse events of special interest (AESI)(Baseline to Week 332)
- Percentage of participants who experienced TEAE leading to treatment discontinuation(Baseline to Week 332)
- Absolute change from DRI17366 baseline in EASI score at each LTS17367 visit in participants entering the study from DRI17366 Week 24(DRI17366 Baseline to Week 332)
- Percent change from DRI17366 baseline in EASI score at each LTS17367 visit in participants entering the study from DRI17366 Week 24(DRI17366 Baseline to Week 332)
- Proportion of participants with EASI50/EASI75/EASI90/EASI100 from DRI17366 baseline at each LTS17367 visit in participants entering the study from DRI17366 Week 24(DRI17366 Baseline to Week 332)
- 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(Baseline to Week 332)
- Proportion of participants with vIGA-AD score 0/1 in all participants entering the study [each LTS17367 visit](Baseline to Week 332)
- Proportion of participants with vIGA-AD score 0 [each LTS17367 visit](Baseline to Week 332)
- Proportion of participants with vIGA-AD score 0 or 1 with presence of only barely perceptible erythema (no induration/papulation, no lichenification, no oozing or crusting) at each LTS17367 visit(Baseline to Week 332)
- Time to first vIGA-AD 0/1 after LTS17367 enrollment in those participants who had not achieved vIGA-AD 0/1 by the time of LTS17367 enrollment(Baseline to Week 332)
- Absolute change from feeder study baseline in EASI score in all participants entering the study [each LTS17367 visit](Baseline to Week 332)
- Percent change from feeder study baseline in EASI score in all participants entering the study [each LTS17367 visit](Baseline to Week 332)
- Proportion of participants with EASI50/EASI75/EASI90 in all participants entering the study [each LTS17367 visit](Baseline to Week 332)
- Time to first EASI75/EASI90 in those participants who had not achieved it by the time of LTS17367 enrollment(Baseline to Week 332)
- Proportion of participants requiring topical treatment in all participants entering the study [each LTS17367 visit](Baseline to Week 332)
- Proportion of participants requiring rescue treatment [each LTS17367 visit]: all treatments in all participants entering the study(Baseline to Week 332)
- Number of days on topical medication (per patient-year) in all participants entering the study(Baseline to Week 332)
- Change from feeder study baseline atopic dermatitis control tool (ADCT) in all participants entering the study [each LTS17367 visit](Baseline to Week 332)
- Change from feeder study baseline in dermatology life quality index (DLQI/cDLQI) in all participants entering the study [each LTS17367 visit](Baseline to Week 332)
- Change from feeder study baseline in patient oriented eczema measure (POEM) in all participants entering the study [each LTS17367 visit](Baseline to Week 332)
- Change from feeder study baseline in body surface area affected by AD (BSA-AD) [each LTS17367 visit](Baseline to Week 332)
- Time from enrollment in LTS17367 to first loss of vIGA-AD 0 in those participants who were vIGA-AD 0 at LTS17367 rollover from EFC17600 (ESTUARY) and EFC17599 (AQUA)(Baseline to Week 332)
- Time from enrollment in LTS17367 to first loss EASI75 in those participants who had reached EASI75 at LTS17367 rollover coming from EFC17600 (ESTUARY) and EFC17599 (AQUA)(Baseline to Week 332)
- Time from enrollment in LTS17367 to first loss of vIGA-AD 0/1 in those participants who were vIGA-AD 0/1 at LTS17367 rollover from EFC17600 (ESTUARY) and EFC17599 (AQUA)(Baseline to Week 332)
- Time from LTS17367 baseline to re-treatment with amlitelimab in those participants who were vIGA-AD 0/1 at LTS17367 rollover from EFC17600 (ESTUARY) and EFC17599 (AQUA)(Baseline to Week 332)
- Time from last amlitelimab dose in feeder study to re-treatment with amlitelimab in those participants who were vIGA-AD 0/1 at LTS17367 rollover from EFC17600 (ESTUARY) and EFC17599 (AQUA)(Baseline to Week 332)
- Serum amlitelimab concentration assessed at prespecified time points through the end of the study(Baseline to Week 332)
- Number of participants with anti-drug antibodies (ADAs) of amlitelimab at specified timepoints(Baseline to Week 332)
Study Sites (651)
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