Who can participate?
Adults at least 18 years of age with moderate-to-severe Atopic Dermatitis (AD) are needed for this clinical trial.
Inclusion Criteria
* 1% of your body surface area is roughly equal to the palm of your hand (no wrists or fingers)
What are the benefits?
As a participation in our research trial, you will receive an investigational treatment (active study drug) or placebo via injection entirely free of cost. All study-related assessments will also be provided at no charge. In addition, you may also be eligible for reimbursement of study-related expenses.
How long will the study last?
Study lasts for a duration of 40 weeks and involves about 10 visits to the study centre.
Saskatoon - Skinsense Medical Research
Surrey - Dr. Chih-ho Hong Medical Inc.
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Last Update Posted: December 10, 2023
NCT06130566
Sanofi
Brief Summary:
This is a parallel group, Phase 3, multinational, multicenter, randomized, double blind, placebo-controlled, 3-arm monotherapy study for treatment of participants diagnosed with moderate to severe atopic dermatitis (AD), whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for SC injection compared with placebo in participants with moderate to severe AD aged 18 years and older. Study details include: At the end of the treatment period, participants will have an option to enter a separate study: the blinded extension study EFC17600 (ESTUARY). For participants not entering the blinded extension Study EFC17600 (ESTUARY), the study duration will be up to 44 weeks including a 2 to 4-week screening, a 24-week randomized double-blind period, and a 16-week safety follow-up. For participants entering the blinded extension Study EFC17600 (ESTUARY), the study duration will be up to 28 weeks including a 2 to 4-week screening and a 24-week randomized double-blind period. The total treatment duration will be up to 24 weeks. The total number of visits will be up to 10 visits (or 9 visits for those entering the blinded extension study EFC17600] (ESTUARY).
Condition or Disease:
Dermatitis Atopic
Intervention/Treatment:
Drug: AmlitelimabPhase:
Phase 3
Ages Eligible for Study:
18 Years and older (Adult)
Sexes Eligible for Study:
All
Inclusion Criteria:
Participants must be 18 years of age (when signing informed consent form)
Diagnosis of AD for at least 1 year (defined by the American Academy of Dermatology Consensus Criteria)
Documented history (within 6 months before screening) of either inadequate response or inadvisability to topical treatments, and/or inadequate response to systemic therapies (within 12 months before screening)
v-IGA-AD of 3 or 4 at baseline visit
EASI score of 16 or higher at baseline
AD involvement of 10% or more of BSA at baseline
Weekly average of daily PP-NRS of ≥ 4 at baseline visit.
Able and willing to comply with requested study visits and procedures
Body weight ≥40 kg
Exclusion Criteria:
Skin co-morbidity that would adversely affect the ability to undertake AD assessments
Known history of or suspected significant current immunosuppression
Any malignancies or history of malignancies prior to baseline (excluding for non-melanoma skin cancer excised and cured >5 years prior to baseline)
History of solid organ or stem cell transplant
Any active or chronic infection including helminthic infection requiring systemic treatment within 4 weeks prior baseline (1 week in the event of superficial skin infections)
Positive for human immunodeficiency virus (HIV), Hepatitis B or hepatitis C at screening visit
Having active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB
Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit
In the Investigator’s opinion, any clinically significant laboratory results or protocol specified laboratory abnormalities at screening
History of hypersensitivity or allergy to any of the excipients or investigational medicinal product (IMP)
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial
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