Inmagene's IMG-007 atopic dermatitis trial pushes readout into 2027
The ADAPTIVE Phase 2b trial nearly doubled its enrollment target and slid its completion date 13 months, with topline EASI data now expected well past the original Q4 2026 guide.
Executive Summary
- The trial that Inmagene once guided to a Q4 2026 topline readout has pushed its own completion date more than a year later, and the sponsor's latest quarterly update now points to 2027.
- Enrollment nearly doubled from the trial's original target, a change that extends the population the eventual EASI result will be based on rather than signaling a design problem.
- An interim safety look across the sponsor's IMG-007 programs found no serious drug-related events and a low rate of injection-site reactions, keeping the tolerability question open but not concerning so far.
- No other OX40-targeted antibody has produced a late-stage atopic dermatitis result, so this trial's eventual data will stand without a same-mechanism benchmark in the indication.
The trial and the shift
ADAPTIVE (NCT07037901) is a randomized, double-blind, placebo-controlled Phase 2b study testing several subcutaneous dose regimens of IMG-007 against placebo in adults with moderate-to-severe atopic dermatitis who failed or could not tolerate topical therapy. Inmagene Biopharmaceuticals dosed the first patient on July 1, 2025 and originally planned to enroll approximately 220 patients across four arms, with topline data expected in the fourth quarter of 2026. The registry now lists an anticipated enrollment of 405 patients, up from 220, and a primary completion date of December 1, 2027, moved from November 1, 2026, both changed as of May 27, 2026. A subsequent company update on IMG-007's program status points to a Q4 2027 topline readout for the same trial, consistent with the later completion date now on the registry. NCT07037901+1A Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants With Moderate-to-Severe Atopic DermatitisNCT07037901Inmagene Doses First Patient in the ADAPTIVE Phase 2b Trial of IMG-007, a Nondepleting ...Jul 1, 2025
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
What the readout will test
The primary endpoint is the mean percent change from baseline in Eczema Area and Severity Index (EASI, a standard atopic dermatitis severity score) at Week 20. Key secondary measures include the same EASI metric at Week 16, the proportion of patients reaching EASI-75 (at least 75% improvement), and an Investigator's Global Assessment score of clear or almost clear. The trial runs a 20-week placebo-controlled period followed by a 32-week active-treatment period in which placebo patients cross over to IMG-007, and it is explicitly a dose-finding study meant to select regimens for a future Phase 3 program rather than to serve as a registrational trial. NCT07037901+1A Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants With Moderate-to-Severe Atopic DermatitisNCT07037901Inmagene Doses First Patient in the ADAPTIVE Phase 2b Trial of IMG-007, a Nondepleting ...Jul 1, 2025
Enrollment increase in context
An 84% jump in enrollment target for a Phase 2 trial can be read either as a design change or a straightforward scale-up. Here the increase, evaluated against the operational model's routine threshold for enrollment shifts, reads as typical rather than a signal of trouble. The trial remains in Recruiting status, and the enrollment change moved in the same direction as the completion-date extension, consistent with a larger, more statistically powered dataset rather than a rescue of a struggling study. NCT07037901A Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants With Moderate-to-Severe Atopic DermatitisNCT07037901
Safety signal to date
A blinded safety review conducted in March 2026 across IMG-007 studies, including ADAPTIVE, found no cases of Kaposi sarcoma, no malignancies, no severe infections, and no treatment-related serious adverse events, with injection-site reactions occurring in under 0.10% of exposures. That interim read carries no efficacy signal on its own, but it supports continued enrollment without an emergent tolerability problem for a nondepleting OX40-blocking antibody, a mechanism designed to preserve T-cell populations rather than deplete them, per the company's own description of the drug. InmageneInmagene Doses First Patient in the ADAPTIVE Phase 2b Trial of IMG-007, a Nondepleting ...Jul 1, 2025
The competitive frame
The only other clinical-stage OX40-targeted antibody identified in the same target class, Amgen's rocatinlimab, is in Phase 2 testing for asthma rather than atopic dermatitis. No trial sharing IMG-007's target has reported a resolved atopic dermatitis outcome. The atopic dermatitis field itself is active, with Regeneron's dupilumab, AbbVie's risankizumab, and other IL-4Rα, IL-23, and JAK-targeted therapies already approved or in late-stage testing for related inflammatory-skin indications, none of which share IMG-007's OX40 mechanism. Given that mechanistic isolation, a readout that shows a placebo-adjusted EASI reduction sustained through Week 20, without an unexpected tolerability signal in the larger 405-patient cohort, would be the result that gives this trial standing to inform dose selection for a Phase 3 program.
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.