A research study to evaluate if VTX958, a test medicine, not yet approved for doctors to prescribe, is safe and will help in the treatment of psoriasis.
- Conditions
- moderate to severe plaque psoriasisMedDRA version: 20.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2022-002887-59-PL
- Lead Sponsor
- Ventyx Biosciences, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 200
1. Male or female participant aged 18 years or older.
2. History of primarily plaque psoriasis for at least 6 months prior to the screening visit.
3. Has had stable psoriasis conditions for at least 3 months before screening.
4. Has moderate to severe plaque psoriasis as defined by a PASI score of = 12 and an sPGA score of = 3 at screening and Day 1.
5. Has plaque psoriasis covering = 10% of the total BSA at screening and Day 1.
6. Deemed by the investigator to be eligible for phototherapy or systemic therapy.
7. Females of childbearing potential must agree to use a highly effective contraceptive method from at least 4 weeks prior to Day 1 until at least 4 weeks after the last dose of study product.
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 185
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15
1. Female who is breastfeeding, pregnant, lactating, or who is planning to become pregnant during the study.
2. Has evidence of erythrodermic, pustular, predominantly inverse or guttate psoriasis, or drug-induced psoriasis.
3. History of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the study assessments.
4. Participant is known to have immune deficiency or is immunocompromised.
5. Has immune-mediated conditions commonly associated with psoriasis, such as psoriatic arthritis, active uveitis, inflammatory bowel disease, that currently require systemic treatment (including corticosteroids, immunosuppressants, or biologics).
Note: Participants with immune-mediated conditions commonly associated with psoriasis that do not require systemic treatment may be included in the study.
6. Has used any topical medication that could affect psoriasis (including corticosteroids, retinoids, vitamin D analogues [such as calcipotriol], JAK inhibitors, or tar) within 2 weeks prior to Day 1.
7. Has used any systemic treatment that could affect psoriasis (including corticosteroids, oral retinoids, immunosuppressive medication, anakinra, methotrexate, cyclosporine, oral JAK inhibitors, or apremilast) within 4 weeks prior to Day 1.
Note: Intranasal corticosteroids and inhaled corticosteroids are allowed. Eye and ear drops containing corticosteroids are also allowed.
8. Participant has received any ultraviolet B (UVB) phototherapy (including tanning beds) or excimer laser within 4 weeks prior to Day 1.
9. Participant has had psoralen and ultraviolet A (PUVA) treatment within 4 weeks prior to Day 1.
10. Participant has received treatment with an investigational or marketed TYK2 inhibitor.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): • Proportion of participants achieving PASI-75 at Week 16<br>• Incidence of AEs and SAEs<br>• Changes in vital signs, clinical laboratory parameters, and ECGs;Timepoint(s) of evaluation of this end point: • Weeks 16<br>• Screening, Week 0, 1, 2, 4, 8, 12, 16;Main Objective: To determine the efficacy of VTX958 after treatment for 16 weeks in participants with moderate to severe psoriasis.<br>To evaluate the safety and tolerability of VTX958 during the placebo controlled treatment period in participants with moderate to severe psoriasis.;Secondary Objective: To evaluate the efficacy of VTX958 on improvement of various measures of psoriasis after treatment for 16 weeks in participants with moderate to severe psoriasis.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Proportion of participants achieving an sPGA score of 0 (clear) or 1 (almost clear) at Week 16 <br>• Change and percent change from baseline in PASI at Week 16 <br>• Proportion of participants achieving PASI-90 at Week 16 <br>• Proportion of participants achieving PASI-100 at Week 16 <br>• Change from baseline in DLQI scores at Week 16 <br>• Change from baseline in BSA at Week 16 <br>;Timepoint(s) of evaluation of this end point: Weeks 16