A Study Assessing Rocatinlimab in Combination with Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants with Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-SHUTTLE)
This is a phase 3, 24-week, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of rocatinlimab in combination with TCS/TCI in adult subjects with moderate-to-severe AD with inadequate response to topical medications.
This study is designed io evaluate the efficacy of rocatinlimab in combination with topical corticosteroid and/or topical calcineurin inhibitor (TCS/TCI), compared with placebo in combination with TCS/TCI at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD™). This study will also evaluate the efficacy of rocatinlimab, in combination with TCS/TCI, compared with placebo in combination with TCS/TCI at Week 24, assessed using Eczema Area and Severity Index (EASI).
- Subject has provided informed consent prior to initiation of any study specific activities/procedures.
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- Age = 18 years at signing of informed consent.
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- Subject has a diagnosis of Atopic Dermatitis (according to American Academy of Dermatology Consensus Criteria) that has been present for at least 6 months before signing of informed consent.
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Prior to informed consent, history of inadequate response to TCS of medium or higher potency within 6 months (with or without TCI as appropriate).
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- Active malignancy, multiple myeloma, myeloproliferative or lymphoproliferative disorder, or a history of any of these conditions within 5 years prior to informed consent (except curatively treated in situ cervical carcinoma, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma).
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- History of major immunologic reaction (eg, serum sickness, anaphylaxis, or anaphylactic reaction) to any other biologic product or any excipient of rocatinlimab.
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- Diagnosis of a helminth parasitic infection within 6 months prior to day 1 prerandomization that had not been treated with or had failed to respond to standard of care therapy.
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- Evidence of human immunodeficiency virus (HIV) infection or positive for HIV antibodies at initial screening or current acquired, common variable or inhibited, primary or secondary immunodeficiency.
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Positive for hepatitis C virus (HCV) antibody at initial screening with confirmed positive HCV RNA.
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