A Study to Evaluate ESK-001 in Patients with Psoriasis
- Conditions
- Moderate to Severe Plaque PsoriasisMedDRA version: 20.0Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2022-002633-34-CZ
- Lead Sponsor
- Alumis Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 210
1. Able and willing to provide signed informed consent to participate in this study
2. Males or females, age 18-75 years, inclusive, at the Screening Visit
3. Total body weight >40 kg (88 lb), BMI > 18 kg/m2
4. Diagnosis of plaque psoriasis for =6 months
5. Plaques covering =10% of body surface area (BSA)
6. Psoriasis area severity index score (PASI) score =12 and static Physician’s Global Assessment (sPGA) score =3
7. Women of childbearing potential (WOCBP) must agree to adhere to highly effective methods of contraception for the entirety of the study and for 30 days after the last dose of study drug
8. Males who are sexually active with WOCBP must agree to use highly effective methods of contraception for the entirety of the study and for 90 days after the last dose of study drug
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
1. Diagnosis of non-plaque psoriasis (guttate, inverse, pustular, erythrodermic, drug induced)
2. Diagnosis of immune-mediated conditions that are commonly associated with psoriasis (e.g., uveitis, inflammatory bowel disease) or other inflammatory skin conditions that may interfere with the study assessment
3. Patients with psoriatic arthritis who are receiving systemic (oral, SC, IM or IV) immunosuppressant medications (including corticosteroids, immunosuppressant biologics) or who has or is expected, in the opinion of the investigator, to develop unstable disease.
• Patients who are receiving a stable therapeutic regimen for their psoriatic arthritis that does not include immunosuppressants (e.g. NSAIDs) may be included in the study
4. Pregnant, lactating, or planning to get pregnant during the study period
5. Has used topical medications/treatments that could affect psoriasis evaluation within 2 weeks of the first administration of study drug
6. Has received phototherapy or any systemic medications/treatments that could affect psoriasis evaluation within 4 weeks of Study Day 1
7. Has received any therapeutic agent targeted to: IL-12or IL-23 within 6 months, IL-17 within 4 months, or any TNFa inhibitor(s) within 2 months of first administration of study drug
8. Is currently receiving or has received any systemic immunosuppressants or immunomodulatory drugs (e.g., methotrexate, cyclosporine) within 4 weeks of the first administration of study drug or 5 half-lives whichever is longer
9. Has received agents that modulate B cells (e.g., rituximab, ocrelizumab) within 6 months of first administration of study drug
10. Has received agents that modulate T cells (e.g., abatacept, alemtuzumab) within 3 months of first administration of study drug
11. Has received JAK inhibitors (e.g., baricitinib, tofacitinib) or TYK2 inhibitors within 4 weeks of first administration of study drug
12. History of lack of clinical response to any therapeutic agent targeted to IL-12, IL-17 or IL-23 (e.g., ustekinumab, risankizumab, secukinumab, ixekizumab) at approved doses after at least 3 months of treatment
13. History of lack of clinical response, in the Investigator’s opinion, to 2 or more biologic therapies at approved doses after at least 3 months of treatment
14. Has received any investigational agent, within 30 days or 5 half-lives (whichever is longer) of any study drug or is currently enrolled in an investigational study
15. Is currently receiving proton pump inhibitors such as omeperazole or esomeprazole. It is acceptable to substitute a histamine 2 receptor blocking drug or oral antacids prior to Study Day 1
16. Patients with QTcF >450 msec (males) or >470 msec (females) at screening
17. Unstable cardiovascular disease, defined as a recent clinical deterioration (e.g., unstable angina, rapid atrial fibrillation) or a cardiac hospitalization within the last 3 months
• Patients requiring medications to treat underlying stable chronic cardiovascular disease, including but not limited to ß-blockers, should be on a stable dose for at least 4 weeks before Study Day 1
18. Active herpes viral infection, including herpes simplex 1 and 2 and herpes zoster identified on examination and/or medical history within 2 months of administration of study drug
19. Patients with hepatitis C virus (HCV), or hepatitis B virus (HBV) or human immunodeficiency virus (HIV) or active or inadequately treated latent tuberculosis (TB) infection at screening
20. Has any of the fol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the Psoriasis Area and Severity Index (PASI-75) between doses of ESK-001 and placebo after 12 weeks of treatment;Secondary Objective: 1.To assess the safety and tolerability of ESK-001 dose in moderate to severe psoriasis patients.<br>2. To characterize the pharmacokinetics (PK) of ESK-001.<br>3.To assess the response rate in static Physician’s Global Assessment (sPGA) score after 12 weeks of treatment.<br>4.To assess the response rate in PASI-50,90, and 100 score after 12 weeks of treatment.<br>5.To compare the response rate in PASI-75 among ESK-001 treatments.<br>6.To assess the effect on body surface area (%BSA) involved with psoriasis after 12 weeks of treatment.<br>7.To assess the change in Dermatology Life Quality Index (DLQI);Primary end point(s): • Proportion of patients with moderate to severe psoriasis achieving =75% reduction in PASI score at 12 weeks between doses of ESK-001 and placebo;Timepoint(s) of evaluation of this end point: 12 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)<br>• Plasma concentrations and PK parameters of ESK-001<br>• Proportion of patients achieving an sPGA score of 0” (cleared”) or 1” (minimal”) after 12 weeks of ESK-001 treatment compared with placebo<br>• Proportion of patients achieving PASI-50, 90, and 100 after 12 weeks of ESK-001 treatment compared with placebo<br>• Proportion of patients achieving PASI-75 at 12 weeks compared among the ESK-001 treatments <br>• Change from baseline in %BSA after 12 weeks of ESK-001 treatment compared with placebo. <br>•Change from baseline in DLQI at Week 12 in ESK-001 compared with placebo;Timepoint(s) of evaluation of this end point: 12 weeks