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A multicenter, double-blind, randomized, placebo-controlled, parallel-group, twelve-week treatment proof-of-concept trial to explore the efficacy and safety of IDOR-1117-2520 in adults with moderate to severe chronic plaque psoriasis with or without psoriatic arthritis.

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-523051-64-00
Acronym
ID-091A201
Enrollment
18
Registered
2026-01-07
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-15

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

Conditions

Moderate to severe chronic plaque psoriasis

Brief summary

Change from baseline to Week 12 in Psoriasis Area and Severity Index (PASI) score.

Detailed description

• Achievement of static physician’s global assessment (sPGA) score clear (0), almost clear (1) and ≥ 2 points improvement from baseline to each time point up to Week 12. • Change from baseline and ratio to baseline at each time point up to Week 16 in sPGA score., • Adverse events (AEs) leading to premature discontinuation of trial intervention. • Treatment-emergent AEs and serious adverse events (SAEs). • Change from baseline to each time point in: - Vital signs - Body weight - Clinical laboratory variables - 12-lead electrocardiogram (ECG) • Treatment-emergent marked abnormalities for: - Vital signs - Clinical laboratory variables - 12-lead ECG

Interventions

DRUGIDOR-1117-2520 matching placebo

Sponsors

Idorsia Pharmaceuticals Ltd.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change from baseline to Week 12 in Psoriasis Area and Severity Index (PASI) score.

Secondary

MeasureTime frame
• Achievement of static physician’s global assessment (sPGA) score clear (0), almost clear (1) and ≥ 2 points improvement from baseline to each time point up to Week 12. • Change from baseline and ratio to baseline at each time point up to Week 16 in sPGA score., • Adverse events (AEs) leading to premature discontinuation of trial intervention. • Treatment-emergent AEs and serious adverse events (SAEs). • Change from baseline to each time point in: - Vital signs - Body weight - Clinical laboratory variables - 12-lead electrocardiogram (ECG) • Treatment-emergent marked abnormalities for: - Vital signs - Clinical laboratory variables - 12-lead ECG

Countries

Bulgaria, Romania

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026