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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06586112




Registration number
NCT06586112
Ethics application status
Date submitted
14/08/2024
Date registered
19/09/2024
Date last updated
27/12/2024

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients with Moderate to Severe Plaque Psoriasis
Scientific title
A Multicenter, Randomized, Double-Blind, Placebo and Active Comparator Controlled Phase 3 Study to Evaluate the Efficacy and Safety of ESK-001 in Patients with Moderate to Severe Plaque Psoriasis (ONWARD1)
Secondary ID [1] 0 0
ESK-001-016
Universal Trial Number (UTN)
Trial acronym
ONWARD1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Plaque Psoriasis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ESK-001
Treatment: Drugs - Apremilast
Treatment: Drugs - Placebo

Experimental: ESK-001 - ESK-001 administered as an oral tablet

Placebo comparator: Placebo - Matching oral placebo

Active comparator: Apremilast - Apremilast administered as an oral capsule


Treatment: Drugs: ESK-001
ESK-001

Treatment: Drugs: Apremilast
Apremilast

Treatment: Drugs: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To determine whether ESK-001 reduces the severity of psoriasis by 75% (using the PASI) or by at least 2 points (using sPGA score) compared to placebo
Timepoint [1] 0 0
16 weeks
Secondary outcome [1] 0 0
To compare the Psoriasis Area and Severity Index (PASI-90 and PASI-100) between ESK-001 and placebo or apremilast
Timepoint [1] 0 0
24 weeks
Secondary outcome [2] 0 0
To compare the Psoriasis Area and Severity Index (PASI-75) between ESK-001 and apremilast
Timepoint [2] 0 0
24 weeks
Secondary outcome [3] 0 0
To compare the Static Physician's Global Assessment (sPGA-0/1) between ESK-001 and apremilast
Timepoint [3] 0 0
24 weeks
Secondary outcome [4] 0 0
To compare the affected body surface area (%BSA) between ESK-001 and placebo or apremilast
Timepoint [4] 0 0
24 weeks
Secondary outcome [5] 0 0
To compare the scalp specific Physician's Global Assessment (ssPGA) between ESK-001 and placebo or apremilast.
Timepoint [5] 0 0
24 weeks
Secondary outcome [6] 0 0
To compare the Psoriasis Symptoms and Signs Diary (PSSD) between ESK-001 and placebo or apremilast
Timepoint [6] 0 0
24 weeks
Secondary outcome [7] 0 0
To compare the Dermatology Life Quality Index (DLQI) between ESK-001 and placebo or apremilast
Timepoint [7] 0 0
24 weeks
Secondary outcome [8] 0 0
To compare the Pruritus numeric rating scale (NRS) between ESK-001 and placebo
Timepoint [8] 0 0
24 weeks
Secondary outcome [9] 0 0
Proportion of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Timepoint [9] 0 0
24 weeks
Secondary outcome [10] 0 0
To characterize the pharmacokinetics of ESK-001
Timepoint [10] 0 0
24 weeks

Eligibility
Key inclusion criteria
1. Males or females, age =18 years
2. Diagnosis of plaque psoriasis for =6 months
3. Plaques covering =10% of BSA
4. PASI =12
5. sPGA =3
6. Women of childbearing potential (WOCBP) and males who are sexually active with WOCBP must agree to adhere to highly effective methods of contraception
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Nonplaque psoriasis or other inflammatory skin conditions
2. immune-mediated conditions commonly associated with psoriasis (eg inflammatory bowel disease). Participants with psoriatic arthritis may participate
3. Pregnant, lactating, or planning to get pregnant during the study
4. Use of drugs prior to Study Day 1 that treat or may affect psoriasis:

* Topical within 2 weeks
* Phototherapy or any systemic treatments within 4 weeks
* Any biologic agent targeted to IL-12 or IL-23 within 6 months, oral IL-12 or IL-23 or TNFa inhibitor within 2 months, or IL-17 within 4 months
* Systemic immunosuppressants or immunomodulatory drugs within 4 weeks
* Modulators of B cells within 6 months, or T cells within 3 months
* JAK inhibitors or TYK2 inhibitors within 4 weeks
* PDE4 inhibitor within 2 months
* Any investigational agent, within 30 days or 5 half-lives or is currently enrolled in an investigational study
5. Lack of clinical response to a TYK2, IL-12, or IL-23 targeted psoriasis treatment
6. Participants with QTcF >450 msec (males) or >470 msec (females) at Screening
7. Unstable cardiovascular disease, defined as a recent clinical deterioration or a cardiac hospitalization within the last 3 months
8. Evidence of recent or recurrent herpes zoster or herpes simplex viral infection
9. Evidence of active infection or positive test result for hepatitis B, hepatitis C, HIV or TB
10. History of serious bacterial, fungal, or viral infections that led to hospitalization, or any recent serious infection requiring antibiotic treatment
11. Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status
12. Lab abnormalities indicating significant renal, hepatic or bone marrow dysfunction
13. History of any immune-mediated or inflammatory medical condition for which participants requires current systemic corticosteroids

* Stable doses of inhaled corticosteroids for treatment of asthma are allowed
14. Known current malignancy or current evaluation for a potential malignancy or history of malignancy within the past 5 years prior to screening, except for adequately treated basal cell or squamous cell skin carcinoma or carcinoma in situ of the cervix
15. Live vaccines within 4 weeks prior to Study Day 1
16. Participant has planned surgery during the study period
17. 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 participant if he or she participates in the study
18. History of mental illness within the last 5 years, unless receiving a fixed regimen of psychiatric medications for at least 6 months before screening or has not required or been prescribed any psychiatric medication within 12 months before screening
19. Evidence of severe depressive symptoms or active suicidal ideation or behavior

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/07/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2026
Actual
Sample size
Target
840
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Premier Specialists - Kogarah
Recruitment hospital [2] 0 0
North Eastern Health Specialists (NEHS) - Campbelltown
Recruitment hospital [3] 0 0
Skin Health Institute Inc. - Carlton
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
5074 - Campbelltown
Recruitment postcode(s) [3] 0 0
3053 - Carlton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Idaho
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Oklahoma
Country [16] 0 0
United States of America
State/province [16] 0 0
Oregon
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
South Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
South Dakota
Country [20] 0 0
United States of America
State/province [20] 0 0
Tennessee
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Washington
Country [23] 0 0
Canada
State/province [23] 0 0
British Columbia
Country [24] 0 0
Canada
State/province [24] 0 0
Ontario
Country [25] 0 0
Canada
State/province [25] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Alumis Inc
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The goal of this clinical trial is to learn if ESK-001 works to treat moderate to severe plaque psoriasis. The main questions it aims to answer are:

* Does ESK-001 reduce the severity of people's psoriasis?
* How safe is ESK-001 in people with moderate to severe plaque psoriasis?

The study includes 2 comparators: a placebo control (a 'dummy' tablet that does not contain the medicine ESK-001 but looks just like it) and an active control (apremilast, which is a medicine approved to treat psoriasis).

People taking part in this study must be men or women aged at least 18 years and have had plaque psoriasis for at least 6 months, currently moderate to severe.

Participants will:

* take drug every day for 24 weeks.
* visit the clinic for checkups and tests.
* fill out questionnaires about their psoriasis, itch severity, and change in quality of life.
* be assessed for health issues and side effects, physical examinations, vital signs, heart electrical activity measurements, and psychological health.
* provide blood and urine samples.
Trial website
https://clinicaltrials.gov/study/NCT06586112
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Alumis Information
Address 0 0
Country 0 0
Phone 0 0
(650) 231-6625
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06586112