Long-Term Safety and Efficacy Evaluation of Amlitelimab in Participants of Previous Amlitelimab Moderate to Severe Atopic Dermatitis Clinical Trials (RIVER-AD)

Sanofi

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Dermatitis Atopic

Treatments: Drug: Oral corticosteroids; Drug: Amlitelimab; Drug: Topical corticosteroids; Drug: Topical calcineurin inhibitors

Study type: Interventional

Funder types: Industry

Identifiers

NCT05492578

U1111-1269-6490 (Registry Identifier)

2021-002344-73 (EudraCT Number)

LTS17367

2023-506548-18 (Registry Identifier)

Details and patient eligibility

About

This is a single group, Phase 2/3, long-term extension study for treatment. 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 (Q4W). Responder participants rolling over from EFC17599 and EFC17600, and 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. 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.

Enrollment: 1,310 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,310 participants in 1 patient group

Amlitelimab

Experimental group

Description:

Subcutaneous injection

Treatment:

Drug: Topical calcineurin inhibitors

Drug: Topical corticosteroids

Drug: Amlitelimab

Drug: Oral corticosteroids