Double-blind Phase III maintenance study to assess Rocatinlimab in moderate to severe AD (ROCKET-ASCEND)
Descrizione riassuntiva dello studio
Participants receive every 4 weeks (last dose at week 20), with 1 additional dose at week 2, either Rocatinlimab 300 mg, Rocatinlimab 150 mg, or placebo as an injection. From the first dose of either Rocatinlimab or placebo, participants apply topical TCS and/or TCI daily until they receive further instructions from the investigator. After the first dose of Rocatinlimab, participants are observed for 2 hours on Day 1, and for 30 minutes after all other doses. Participants use a moisturizer cream twice daily. After the first 6 weeks of the study, medications that are typically used by physicians to treat AD and approved by the health authority for AD may be administered if a participant has symptoms that do not improve or worsen, and if the physician believes that additional medication (rescue) is necessary.
(BASEC)
Intervento studiato
This is a Phase III study, the final stage in the development process for human medicines. Researchers want to assess whether Rocatinlimab in combination with a TCS/TCI is effective and well-tolerated compared to a placebo in combination with TCS/TCI for the treatment of AD and whether the drug causes side effects. Until the end of the study, neither participants nor doctors will know which investigational product each participant has received. This is to ensure that the study results are not influenced in any way. The study may last up to 40 weeks for each participant and consists of a pre-screening phase of up to 30 days, a 24-week treatment phase, and a safety follow-up appointment that takes place 16 weeks after the last dose of Rocatinlimab at week 20. If participants continue treatment with Rocatinlimab throughout the study, they may then participate in a long-term maintenance study where they can continue to be treated with Rocatinlimab.
(BASEC)
Malattie studiate
Atopic dermatitis is a chronic skin condition that leads to itching and redness. Researchers want to find out if Rocatinlimab is safe and can help adults with moderate to severe AD whose symptoms do not improve or resolve with topical (i.e., applied directly to the skin) medication alone, or if it is a treatment for adults who cannot receive topical medications due to sensitive skin/allergic reactions. In this study, Rocatinlimab, an immunoglobulin-based therapy, is used in combination with topical corticosteroids (TCS/TCI). It is compared to a placebo.
(BASEC)
The study will include men and/or women aged at least 18 years with moderate to severe AD diagnosed by a physician at least 6 months prior to the initial screening and who continues to persist at the initial screening and on Day 1 prior to enrollment. Participants must have treated their AD for at least 28 days (or over the recommended treatment duration for the medication) with daily applied topical corticosteroids (with or without TCI), without any decrease or resolution of AD symptoms in the 6 months prior to the informed consent. (BASEC)
Criteri di esclusione
Participants with other significant conditions at baseline (e.g., cancer, severe depression) and participants who are prone to severe allergic reactions or infections, or who have taken or are currently taking other medications that are not allowed in the study. Pregnant or breastfeeding women are not allowed to participate in the study. (BASEC)
Luogo dello studio
Berna, Ginevra, Losanna, San Gallo, Zurigo
(BASEC)
Sponsor
AMGEN Inc
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Prof Antonio Cozzio
+41 71 494 11 11
antonio.cozzio@clutterkssg.chHOCH Kantonsspital St. Gallen
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Ethikkommission Ostschweiz EKOS
(BASEC)
Data di approvazione del comitato etico
15.05.2023
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
A Phase 3, Randomized, 24-week, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab (AMG 451) in Combination With Topical Corticosteroids and/or Topical Calcineurin Inhibitors in Adult Subject (BASEC)
Titolo accademico
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Titolo pubblico
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Malattie studiate
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Intervento studiato
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Tipo di studio
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Disegno dello studio
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Criteri di inclusione/esclusione
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non disponibile
Endpoint primari e secondari
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Data di registrazione
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Inclusione del primo partecipante
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Sponsor secondari
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Contatti aggiuntivi
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ID secondari
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Risultati-Dati individuali dei partecipanti
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Ulteriori informazioni sullo studio
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Risultati dello studio
Riepilogo dei risultati
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Link ai risultati nel registro primario
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