A Phase 3, 24-week, Randomized, Placebo-controlled, Double-blind Study to Assess the Effect of Rocatinlimab on Vaccine Antibody Response in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET - VOYAGER)
D
David Rosmarin
Primary Investigator
Overview
This study is being done to find out how well tetanus and meningococcal (brain and blood bacterial infection) vaccination works in participants who have been treated with Rocatinlimab.
Rocatinlimab is a protein-based drug designed specifically to attach to and prevent the function of a protein named OX40 on cells that are involved in inflammation (swelling) and may be another treatment option for inflammatory skin diseases.
Description
Participants who meet the study requirements and take part in it will be in this study for about 40 weeks (approximately 9 months). This includes:
• A screening period of up to 30 days
• A treatment period of 20 weeks
• A week 24 visit or end of treatment (EOT) visit for participants who prematurely discontinue the study drug and do not complete the remaining study visits through week 24 for any reason during the study and must complete end of treatment visit following the last dose of the study drug. Participants who discontinue the study drug will not be eligible to participate in the long-term maintenance study. A safety follow-up visit that occurs approximately 16 weeks after the last dose of study drug (given in week 20) in case participants do not continue into the long term maintenance study.
Participants will have to stop taking drug therapies for AD including: systemic steroids, some topical steroids (medication which are applied directly to the skin), or other medicated lotions and creams as well as biologic or targeted-small molecules (e.g., janus kinase [JAK] inhibitors) among others for an adequate period before they can participate in this study.
The long‑term
maintenance study may provide participants with access to Rocatinlimab for a period beyond
the end of this study. Participants' study doctor
can provide them with further information on participation in this study.
Eligibility
You may be eligible for this study if you meet the following criteria:
-
Conditions:
atopic dermatitis, AD
-
Age: Between 18 Years - 54 Years
-
Gender: All
Inclusion Criteria:
- Subject has a diagnosis of AD (according to American Academy of Dermatology Consensus Criteria) that has been present for at least 6 months before signing of informed consent.
- Prior to informed consent, history of inadequate response to topical corticosteroids of medium-potency or high-potency (with or without TIS, as appropriate) or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks).
- vIGA-AD score 3 (on the 0 to 4 vIGA-AD scale, in which 3 is moderate and 4 is severe) at initial screening.
- vIGA-AD score 3 (on the 0 to 4 vIGA-AD scale, in which 3 is moderate and 4 is severe) at day 1 prerandomization.
Exclusion Criteria:
- 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).
- History of major immunologic reaction (eg, serum sickness, anaphylaxis, or anaphylactic reaction) to any other biologic product or any excipient of rocatinlimab.
- History of Guillain-Barré syndrome (GBS).
- Known sensitivity to any of the products or components to be administered during dosing.
- 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.
- 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.
- Positive for hepatitis C virus (HCV) antibody at initial screening with confirmed positive HCV ribonucleic acid (RNA).
- Active and non-virally suppressed hepatitis B infection at initial screening, defined as detectable hepatitis B deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) test in a subject with detectable hepatitis B surface antigen (HBsAg) and/or antibodies to hepatitis B core. Subjects with detectable HBsAg are required to be virally suppressed with an approved hepatitis B antiviral therapy during the study. 209 Positive or indeterminate QuantiFERON GOLD from central laboratory at initial screening
- Additional criteria may apply. See study team for more details.
Updated on
27 Apr 2024.
Study ID: DERM-AMGEN-ROCKET-VOYAGER, 19168
