IDOR-1117-2520C for Chronic plaque psoriasis (moderate to severe)|Psoriatic arthritis

Inclusion criteria

• {"criterion_text":"- Stable moderate to severe chronic plaque psoriasis (with or without psoriatic arthritis) for at least 6 months (clinical diagnosis) before screening.\n- Psoriasis Area and Severity Index (PASI) score ≥ 12, static physician’s global assessment (sPGA) score ≥ 3, and affected body surface area ≥ 10 % at both Screening and randomization.\n- Participant must be a candidate for systemic therapy, including phototherapy, for psoriasis treatment, as judged by the investigator.\n- For participants of childbearing potential: - have a negative pregnancy test at Screening and at randomization - agree to use a highly effective method of contraception from Screening up to 30 days after permanent trial intervention discontinuation, be sexually inactive, or have a vasectomized partner - agree to undertake monthly urine pregnancy tests during the trial and up to at least 30 days after discontinuation of trial intervention."}

Exclusion criteria

• {"criterion_text":"- Any other significant clinically unstable medical condition, or acute illness within 1 month prior to Screening, that, in the investigator’s opinion, could interfere with the participant’s ability to comply with trial assessments or abide by trial restrictions.\n- Generalized erythrodermic, generalized pustular (von Zumbusch), guttate, scalp only, and palmo-plantar psoriasis only.\n- Current drug-induced psoriasis (including a new onset or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium).\n- Active skin infections (e.g., sores, blisters) or concurrent skin disease (e.g., acne) of significant severity which could potentially interfere with the trial evaluation (e.g., evaluation of skin pathology) or any other skin comorbidities that could interfere with trial assessments."}

Primary endpoints

• {"endpoint_text":"- Change from baseline to Week 12 in Psoriasis Area and Severity Index (PASI) score.","definition_or_measurement_approach":"Change from baseline to Week 12 in PASI score (measurement: Psoriasis Area and Severity Index assessed at baseline and Week 12)."}

Secondary endpoints

• {"endpoint_text":"- • 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.","definition_or_measurement_approach":"Assessment of sPGA categories (clear, almost clear) and ≥2-point improvement from baseline at scheduled time points up to Week 12; change from baseline and ratio to baseline in sPGA up to Week 16."}
• {"endpoint_text":"- • 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","definition_or_measurement_approach":"Safety assessments including recording of AEs leading to discontinuation, treatment-emergent AEs/SAEs; serial measurements of vital signs, body weight, clinical labs and 12-lead ECG at scheduled time points; identification of treatment-emergent marked abnormalities in these measures."}

Bulgaria

Earliest CTIS Part Ii Submission Date

21-11-2025

Latest Decision Or Authorization Date

07-01-2026

Processing Time Days

47

Number Of Sites

1

Number Of Participants

6

Romania

Earliest CTIS Part Ii Submission Date

02-12-2025

Latest Decision Or Authorization Date

12-01-2026

Processing Time Days

41

Number Of Sites

2

Number Of Participants

12

Primary sponsor

Full Name

Idorsia Pharmaceuticals Ltd.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland

Contract research organisations

Name

Swiss BioQuant AG

Responsibilities

PK-PD analysis

Name

SanaClis s.r.o.

Responsibilities

Responsibilities indicated by sponsorDuties codes: 1,10,3,5,6

Name

ARENSIA Exploratory Medicine GmbH

Responsibilities

Responsibilities indicated by sponsorDuties codes: 11,12,15 (Investigator payments),2

Third parties

• {"country":"Switzerland","full_name":"Swiss BioQuant AG","duties_or_roles":"PK-PD analysis","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Slovakia","full_name":"SanaClis s.r.o.","duties_or_roles":"sponsorDuties codes: 1,10,3,5,6","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"ARENSIA Exploratory Medicine GmbH","duties_or_roles":"sponsorDuties codes: 11,12,15 (Investigator payments),2","organisation_type":"Laboratory/Research/Testing facility"}