Health Condition 1: L209- Atopic dermatitis, unspecified
Conditions
Interventions
Intervention1: amlitelimab drug product: 125 mg/mL amlitelimab solution in a PFS to deliver 250 mg of amlitelimab in a 2 mL injection 250 mg (125 mg/mL)
62.5 mg/mL amlitelimab solution in a PFS to del
Sponsors
Sanofi India Limited (SIL)
Eligibility
Inclusion criteria
Inclusion criteria: - Participant must be at least 12 years of age inclusive, at the time of signing the informed consent. - Participants must have AD as defined by the American Academy of Dermatology Consensus Criteria (45) for 1 year or longer at baseline. - The sponsor may be allowed to close some sub-groups based on the ongoing recruitment to guarantee a diverse population. .AD in patient with intrinsic disease .AD in patients with skin of color .AD patients with co-morbid asthma .AD patients with concurrent hand eczema .AD patients who have an incomplete response or intolerance of approved prior biologics therapies - Participants who stopped biologic treatment due to non-response, partial response, loss of efficacy (e.g., failure to achieve or maintain remission [IGA 0, clear skin to 2, mild disease]) must have been previously treated with biologic (at labelled dose level) for at least 4 months, as confirmed by investigator judgment. - Participants who stopped biologic treatment due to intolerance or AEs to the drug may enter the study with no required prior length of biologic treatment. - Participant must have documented history within 6 months prior to screening visit, of either inadequate response or inadvisability of topical treatments - EASI of 16 or higher at baseline visit. - vIGA-AD of 3 or 4 at baseline visit (on the 0 to 4 vIGA-AD scale, vIGA-AD 3 and 4 for moderate and severe respectively). - AD involvement of 10% or more of BSA at baseline visit. - Weekly average of daily PP-NRS of = 4 at baseline visit. This calculation shall include all reported values in the 7 days immediately preceding the baseline visit. A minimum of 4 scores is required to allow calculation of the average. For participants who have not entered at least 4 daily PP-NRS during the 7 days immediately preceding the planned enrollment date, enrollment should be postponed until this requirement is met, but without exceeding the 28-day maximum duration for screening. - Must demonstrate understanding and appropriate use of the e-diary and participant questionnaires, including collection of PP-NRS prior to baseline visit. - Able and willing to comply with requested study visits and procedures. - Body weight must be greater than or equal to 25 kg - Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. a) Male participants Male participants are eligible to participate if they agree to the following during the study intervention period and for at least 5 months after the last administration of study intervention: • Refrain from donating sperm • Plus either: - Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent, OR - Must agree to use contraception/barrier as detailed below: - A male condom; the participant should also be advised of the benefit for a female partner to use a highly effective method of contraception (as will be described in Appendix 4 (Section 10.4): Contraceptive and barrier guidance) as a condom may break or leak when having sexual intercourse with a WOCBP who is not currently pregnant - b) Female participants A female participant is eligible to participate if she is not pregnant or breastfeeding, a
Exclusion criteria
Exclusion criteria: E 01. Skin co-morbidity that would adversely affect the ability to undertake AD assessments (eg, psoriasis, tinea corporis, lupus erythematosus) as per investigator’s judgment E 02. Known history of or suspected significant current immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration. E 03. Any malignancies or history of malignancies prior to baseline (except for in situ cervical carcinoma that has been excised and cured, or non-melanoma skin cancer that has been excised and cured for more than 3 years prior to baseline). E 04. History of solid organ or stem cell transplant. E 05. Any pre-planned major elective surgery known about at baseline that in the opinion of the investigator would necessitate that IMP be permanently discontinued or require more than three doses to be missed. E 06. Severe concomitant illness that would in the Investigator’s opinion inhibit the participant’s participation in the study, including for example, but not limited to, hypertension, renal disease, neurological conditions, heart failure and pulmonary disease. E 07. Any medical or psychiatric condition which, in the opinion of the Investigator may present an unreasonable risk to the study participants as a result of his/her participation in this clinical study, may make participant’s participation unreliable, or may interfere with study assessments. E 08. Any active or chronic infection including helminthic infection requiring systemic treatment within 2 weeks prior to baseline (1 week in the event of superficial skin infections); or any active infection (including confirmed Covid-19 infection at screening or baseline) which as per Investigator’s opinion inhibit the participant’s participation in the study. E 09. Treatment with live (attenuated) vaccines within 12 weeks prior to baseline; failure to complete non-live immunizations required by local regulation (eg, vaccination for COVID-19) at least 14 days prior to baseline E 11. Concurrent participation in any other clinical study, including non-interventional studies. E 12. Participants positive for human immunodeficiency virus; participants with any of the following results at Screening (Visit 1): Positive (or indeterminate) HBsAg, or positive IgM HBcAb, or positive total HBcAb confirmed by positive HBV DNA; positive HCVAb confirmed by positive HCV RNA. See Section 10.8 for Japan-specific requirements. E 13. Participants with active TB, latent TB, a history of incompletely treated TB, suspected extrapulmonary TB 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. Note: TB testing is mandatory to rule out active/latent TB and should be performed and assessed according to local guidelines. If no local guidelines are available and/or TB tests are not locally available, a blood sample for QuantiFERON® Tuberculosis Gold InterferonGamma Release Assay (IGRA) testing should be sent to the central laboratory. Participants with a confirmed positive IGRA test are excluded from the study unless all of the following conditions are met: i) have a history of prior documented completed chemoprophylaxis for latent TB infection (with a treatment regimen as per
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - To characterize the safety of long-term treatment with amlitelimab monotherapy administered by sub-cutaneous (SC) injection in participants with moderate-to-severe AD - Percentage of participants who experienced Treatment-Emergent Adverse Events (TEAEs) - Percentage of participants who experienced Treatment-Emergent Serious Adverse Events (TESAEs)Timepoint: From baseline to Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| - Additional characterization of the safety of long-term treatment with amlitelimab monotherapy administered by SC injection in participants with moderate-to-severe AD - To characterize the efficacy of treatment with amlitelimab monotherapy administered by SC injection in participants with moderate-to-severe AD - To characterize the effect of amlitelimab on measures of Patient-Reported Outcomes (PROs) & quality of life (QoL) - Percentage of participants who experienced Treatment-Emergent Adverse Events of Special Interest (AESI) - Percentage of participants with Potentially Clinically Significant Abnormalities (PCSA) for vital signs & clinical laboratory assessments , & electrocardiogram (ECG)Timepoint: From baseline to Week 52 | — |
Countries
Argentina, Brazil, Canada, Chile, China, Czech Republic, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Poland, Republic of Korea, South Africa, Spain, Taiwan, United Kingdom, United States of America
Contacts
Public ContactVibhawari Waghanna
Sanofi India Limited (SIL)
Outcome results
None listed