Emma Guttman-Yassky, MD, PhD, Outlines Phase 3 SHUTTLE Program with Rocatinlimab for Atopic Dermatitis

Emma Guttman-Yassky, MD, PhD, spoke with Patient Care recently to provide an overview of the global phase 3 ROCKET clinical trial program that is investigating rocatinlimab, an OX40 receptor–targeting therapy designed to rebalance T-cell activity in atopic dermatitis (AD).

Guttman spoke from Paris, where she was attending the 2025 European Academy of Dermatology and Venerology Annual Meeting, held September 17-20. She and colleagues were presenting recent data from 2 of the ROCKET trials, both central to establishing the drug’s clinical profile: ROCKET-IGNITE, which tested rocatinlimab as monotherapy, and ROCKET-SHUTTLE, which evaluated the therapy in combination with topical corticosteroids and/or topical calcineurin inhibitors. Taken together the 2 studies address both regulatory requirements and real-world treatment considerations, supporting the drug's efficacy when used alone as well as in the more typical clinical setting where patients continue topical therapy.

The full ROCKET clinical program includes 8 studies evaluating the safety, efficacy, and long-term impact of the monoclonal antibody in adults and adolescents with moderate-to-severe AD. In the short video above, Guttman-Yassky, lead investigator for the ROCKET-IGNITE study, discusses how these pivotal trials fit into the broader ROCKET program and the path toward approval by the FDA.

The following transcript has been lightly edited for style.

Patient Care: The phase 3 ROCKET clinical trial program that's evaluating rocatinlimab comprises 8 studies. Could you explain where ROCKET-Ignite and ROCKET-Shuttle fit into the sequence of the research?

Emma Guttman, MD, PhD: Yes, they're some of the most important in the sequence, because we are talking here about the two monotherapy studies. So, one was presented at the AAD now the other one is being presented, so I'm presenting the monotherapy, and the one that is the late breaker will be the one with topical steroids. So, these are the three very important studies, because when you add topical steroids, then it's kind of like a real-life situation, right? In real life, patients are utilizing topical steroids. But in the setting of clinical trials for approval for the FDA, the FDA wants also to see it as monotherapy. So, these are the requirements for getting a drug approval. They want to see it approved as a monotherapy, usually and together with topical steroids.