Double-blind Phase III maintenance study to assess Rocatinlimab in moderate to severe AD (ROCKET-ASCEND)
Summary description of the study
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)
Intervention under investigation
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)
Disease under investigation
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)
Exclusion criteria
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)
Trial sites
Bern, Geneva, Lausanne, St. Gallen, Zurich
(BASEC)
Sponsor
AMGEN Inc
(BASEC)
Contact
Contact Person Switzerland
Prof Antonio Cozzio
+41 71 494 11 11
antonio.cozzio@clutterkssg.chHOCH Kantonsspital St. Gallen
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethikkommission Ostschweiz EKOS
(BASEC)
Date of authorisation
15.05.2023
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
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)
Academic title
not available
Public title
not available
Disease under investigation
not available
Intervention under investigation
not available
Type of trial
not available
Trial design
not available
Inclusion/Exclusion criteria
not available
not available
Primary and secondary end points
not available
not available
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available