Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial compared two groups of adults with atopic dermatitis (eczema): 183 people received a placebo (an inactive treatment) and 543 people received a medicine called rocatinlimab at a dose of 300 mg given once every four weeks. The trial measured changes in skin inflammation, overall skin appearance, itching, and skin pain at various points over the study period, using standardised scoring tools rated by doctors and participants themselves. The reported data shows that at 16 weeks, 159 out of 543 participants in the rocatinlimab group had their skin inflammation score reduce by at least 75% (a measure called EASI 75), compared with 23 out of 183 in the placebo group. For overall skin appearance, 69 rocatinlimab participants (out of 543) reached a rating of "clear" or "almost clear" skin, compared with 5 out of 183 in the placebo group. Regarding itch at week 16, 110 rocatinlimab participants (out of those who started with significant itch) reported at least a 4-point drop in their worst daily itch score (on a 0–10 scale), versus 18 in the placebo group. The reported data also shows results at 24 weeks. For itch relief, 121 rocatinlimab participants reported at least a 4-point reduction in their worst itch score, compared with 17 in the placebo group. For a very high level of skin improvement (at least 90% reduction in the inflammation score), 108 rocatinlimab participants met this threshold versus 9 in the placebo group. For skin pain, 109 rocatinlimab participants (among those with significant baseline pain) reported at least a 4-point drop in their skin pain score, compared with 14 in the placebo group. Note that no primary outcome measure data was included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 40012373) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Eczema Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You are 18 years old or older (or the legal adult age in your country) and have been diagnosed with atopic dermatitis (eczema) for at least 12 months
- Your eczema has not responded well enough to medicated creams or ointments (such as steroid creams, with or without other prescription skin creams), or those treatments are not safe for you to use
- Your eczema is rated as moderately severe or worse based on a doctor's assessment of how much of your skin is affected and how bad the inflammation is (confirm with trial site)
- At least 10% of your body surface area is affected by eczema
- Your itching is rated 4 or higher out of 10 on a standard scale
Who may not be able to join:
- You have received a biologic medication (a type of injection-based treatment) within the past 12 weeks or longer, depending on the specific medicine
- You have used steroid tablets or capsules, immune-suppressing medications taken by mouth, light therapy, or JAK inhibitor creams or tablets within the past 4 weeks or longer, depending on the specific medicine
- You have used any steroid skin creams, certain prescription skin creams (such as calcineurin inhibitors or PDE4 inhibitor creams), or other immune-suppressing skin treatments within the past 1 week before the study starts
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: MD, Amgen
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
7 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Number of Participants Who Achieved Validated Investigator's Global Assessment for AD (vIGA-AD) 1 Response With Presence of Only Barely Perceptible Erythema or vIGA-AD 0 Response (Revised Investigator's Global Assessment [rIGA] 0/1) at Week 24; Number of Participants Who Achieved ≥ 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 24
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.