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

Inclusion Criteria:

• Participant must be at least 12 years of age at the time of signing the informedconsent.

• Participated in an amlitelimab clinical trial for moderate to severe AD and receivedstudy treatment, adequately completed the assessments required for the treatmentperiod.

• Have reached the rollover timepoint to LTS17367 at the last visit of thetreatment period of their feeder study SFY17915, INT18404, EFC17599, orEFC17600

• Participants in DRI17366 must only be enrolled from 1 of the following 3groups:

• The first group: participants at Week 24 in the DRI17336 study who havenot achieved an ≥ Eczema Area and Skin Severity Index (EASI)-75 and areInvestigator 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 ofthe 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 beenre-randomized and who subsequently complete the study to Week 52, entersafety follow-up and experience worsening of their AD during safetyfollow-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 thelast visit

• Complied with the previous clinical trial protocol to the satisfaction of theinvestigator

• 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 thepermanent discontinuation

• Known history of or suspected current significant immunosuppression, includinghistory of invasive opportunistic infections or helminthic infections despiteinfection resolution or otherwise recurrent infections of abnormal frequency orprolonged duration

• History of solid organ or stem cell transplant

• Any malignancies or history of malignancies prior to baseline (except fornon-melanoma skin cancer that has been excised and completely cured for more than 5years prior to baseline)

• Participants positive for human immunodeficiency virus; participants with any of thefollowing 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 orpresence of anti-HBs Ab with positive HBV DNA PCR test; positive HCVAb confirmed bypositive HCV RNA

• History (within last 2 years prior to baseline) of prescription drug or substanceabuse, 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 athigh risk of contracting TB (such as close contact with individuals with active orlatent TB) or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeksprior to screening

• Participants with an indeterminate or a confirmed positive IGRA test are excludedfrom the study unless all of the following conditions are met:

1. Have a history of prior documented completed chemoprophylaxis for latent TBinfection (with a treatment regimen as per local guidelines), OR treated foractive TB infection

2. Have been in written form approved for participation in the present trial by aTB specialist who ruled out latent or active TB infection or othermycobacterial 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 thepatient's participation in the study, including for example, but not limited to,hypertension, renal disease, neurological conditions, heart failure and pulmonarydisease

• Skin co-morbidity that would adversely affect the ability to undertake ADassessments (e.g., psoriasis, tinea corporis, lupus erythematosus) as perInvestigator's judgment

• Any medical or psychiatric condition which, in the opinion of the Investigator maypresent an unreasonable risk to the study patient as a result of his/herparticipation 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 medicationsthat 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.