A 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.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Idorsia Pharmaceuticals Ltd.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17], Diseases [C] - Immune System Diseases [C20]

Trial duration

26 Jan 2026 → ongoing

Decision date (initial)

2026-01-07

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Safety, Efficacy

To explore the efficacy of IDOR-1117-2520, compared to placebo, on Psoriasis Area and Severity Index (PASI) score in participants with moderate to severe chronic plaque psoriasis.

Secondary objectives 2

1. To compare the effect of IDOR-1117-2520 to placebo on static physician’s global assessment (sPGA) score in participants with moderate to severe chronic plaque psoriasis.
2. To evaluate the safety and tolerability of IDOR-1117-2520 during 12 weeks of treatment in participants with moderate to severe chronic plaque psoriasis.

Conditions and MedDRA coding

Moderate to severe chronic plaque psoriasis

Study design 4 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. • Stable moderate to severe chronic plaque psoriasis (with or without psoriatic arthritis) for at least 6 months (clinical diagnosis) before screening.
2. • 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.
3. • Participant must be a candidate for systemic therapy, including phototherapy, for psoriasis treatment, as judged by the investigator.
4. • 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 4

1. • 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.
2. • Generalized erythrodermic, generalized pustular (von Zumbusch), guttate, scalp only, and palmo-plantar psoriasis only.
3. • Current drug-induced psoriasis (including a new onset or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium).
4. • 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 2

1. • 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.
2. • 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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Idorsia Pharmaceuticals Ltd.

Sponsor organisation

Idorsia Pharmaceuticals Ltd.

Address

Hegenheimermattweg 91

City

Allschwil

Postcode

4123

Country

Switzerland

Scientific contact point

Organisation

Idorsia Pharmaceuticals Ltd.

Contact name

Idorsia Clinical Trial Information

Public contact point

Organisation

Idorsia Pharmaceuticals Ltd.

Contact name

Idorsia Clinical Trial Information

Third parties 4

Locations

2 EU/EEA countries · 3 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 17 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications