An Extension Study to Evaluate Safety, Efficacy, and Durability of Response to ESK-001 for Moderate to Severe Plaque Psoriasis (ONWARD3)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Alumis Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

13 Jun 2025 → ongoing

Decision date (initial)

2025-05-06

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Alumis Inc.

External identifiers

EU CT number

2024-511166-36-00

ClinicalTrials.gov

NCT06846541

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Efficacy, Therapy, Pharmacodynamic

To assess the long-term safety and tolerability of ESK-001 in patients with moderate to severe plaque psoriasis

Secondary objectives 5

1. 1. To assess the long-term efficacy of ESK-001 in patients with plaque psoriasis
2. 2. To characterize the loss of clinical response only for patients randomized to the withdrawal period of the study
3. 3. To determine the maintenance of ESK-001 clinical response
4. 4. To determine the proportion of clinical nonresponders who achieve a response with long-term treatment with ESK-001
5. 5. To assess the change in quality of life (QoL) with long-term ESK-001 treatment

Conditions and MedDRA coding

Moderate to Severe Plaque Psoriasis

Study design 2 periods

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. 1. Males or females, age ≥18 years
2. 2. Completed either of the two previous (parent) studies of ESK-001 in moderate to severe plaque psoriasis
3. 3. ESK-001 safety and tolerability were acceptable in the parent study
4. 4. Women of childbearing potential (WOCBP) and males who are sexually active with WOCBP must agree to adhere to a highly effective method of contraception for the entirety of the study

Exclusion criteria 3

1. 1. Pregnant, lactating, or planning to get pregnant during the study
2. 2. Any acute or chronic illness/condition or evidence of an unstable clinical condition that, in the opinion of the Investigator, will substantially increase the risk to the patient if they continue to receive ESK-001 treatment in this extension study
3. 3. Deemed by the Investigator to be inappropriate for the study or unable to comply with the protocol

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Incidence and severity of treatment-emergent adverse events and serious adverse events

Secondary endpoints 4

1. Long-term efficacy endpoints: * Achievement of ≥75%, ≥90%, and ≥100% reductions in PASI after 24, 48, 72, 96 weeks of overall ESK-001 treatment * Achievement of sPGA-0, sPGA-0/1 and ssPGA after 24, 48, 72, 96 weeks of overall ESK-001 treatment * Mean change from baseline in PASI %BSA
2. Clinical response endpoints: * Following ESK-001 withdrawal, loss of response in: PASI-75 sPGA-0/1 PASI-90 PASI-100 and median time to loss of response in PASI-75 and sPGA0/1. * After achievement of a response at Week 24 in parent study, maintenance of the response in the following at Weeks 24 and 48 in LTE: PASI-75, PASI-90, and PASI-100 sPGA-0 and sPGA-0/1
3. Clinical response endpoints (continued): * Lack of response at Week 24 in parent study followed by an achievement of response in the following at Weeks 24 and 48 in LTE: PASI-75, PASI-90, and PASI-100 sPGA-0 and sPGA-0/1
4. Quality of life endpoints: * Achievement of the following after 24, 48, 72, 96 weeks of overall ESK-001 treatment: DLQI-0/1 Change from baseline in DLQI, PSSD, NRS (Pruritus, Joint Pain, and Joint Disease Activity), SF-36 * After achievement of a response at Week 24 in parent study, maintenance of the response in the following at Weeks 24 and 48 in LTE: DLQI-0/1 4 point improvement in DLQI PSSD-0

Investigational products

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

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Alumis Inc.

Sponsor organisation

Alumis Inc.

Address

280 East Grand Avenue

City

South San Francisco

Postcode

94080-4808

Country

United States

Scientific contact point

Organisation

Alumis Inc.

Contact name

Clinical Trial Information Desk

Public contact point

Organisation

Alumis Inc.

Contact name

Clinical Trial Information Desk

Third parties 12

Locations

13 EU/EEA countries · 125 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 140 files

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

Application history

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