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A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Soquelitinib in Moderate to Severe Atopic Dermatitis (SIERRA1)

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-524384-20-00
Enrollment
29
Registered
2026-09-18
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic dermatitis (AD)

Brief summary

1. Percent change from Baseline in EASI score at Week 12

Detailed description

1. Response of achieving 75% reduction in EASI (EASI75) score at Wk 12, 2. Response of achieving vIGA score of 0 or 1 with reduction from Baseline of ≥2 points at Wk 12, 3. Response of achieving ≥4-point decrease in PP-NRS score at Wk 12, 4. Change from baseline and percent change in: EASI score, affected BSA and PP-NRS score at each post-baseline visit, 5. Change from baseline and percent change in DLQI score and in POEM score at Wk 12, 6. Incidence, nature, and severity of treatment-emergent adverse events of soquelitinib compared with placebo

Interventions

DRUGPlacebo tablets

Sponsors

Corvus Pharmaceuticals Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
1. Percent change from Baseline in EASI score at Week 12

Secondary

MeasureTime frame
1. Response of achieving 75% reduction in EASI (EASI75) score at Wk 12, 2. Response of achieving vIGA score of 0 or 1 with reduction from Baseline of ≥2 points at Wk 12, 3. Response of achieving ≥4-point decrease in PP-NRS score at Wk 12, 4. Change from baseline and percent change in: EASI score, affected BSA and PP-NRS score at each post-baseline visit, 5. Change from baseline and percent change in DLQI score and in POEM score at Wk 12, 6. Incidence, nature, and severity of treatment-emergent adverse events of soquelitinib compared with placebo

Outcome results

None listed

Source: EU CTIS · Data processed: Sep 19, 2026