VTX958 Versus Placebo for the Treatment of Moderate to Severe Psoriasis (Serenity PsO)

• ClinicalTrials.gov Identifier: NCT05655299
• Recruitment Status: Terminated
• First Posted: December 19, 2022
• Last Update Posted: December 28, 2023
• Sponsor: Ventyx Biosciences, Inc
• Information provided by (Responsible Party): Ventyx Biosciences, Inc

Tracking Information

• First Submitted Date: December 2, 2022
• First Posted Date: December 19, 2022
• Last Update Posted Date: December 28, 2023
• Actual Study Start Date: November 17, 2022
• Actual Primary Completion Date: September 13, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 12, 2023)

• Psoriasis Area and Severity Index (PASI) Efficacy at 16 weeks [ Time Frame: Day 1 of Placebo-controlled treatment period to week 16 ]
  Proportion of subjects achieving PASI-75 at Week 16
• Adverse Event (AE) / Serious Adverse Event (SAE) Incidence Rate through study completion [ Time Frame: Screening through study completion, up to 76 weeks ]
  Incidence of AEs and SAEs

Original Primary Outcome Measures (submitted: December 8, 2022)

• Psoriasis Area and Severity Index (PASI) Efficacy at 16 weeks [ Time Frame: Day 1 of Placebo-controlled treatment period to week 16 ]
  Proportion of subjects achieving PASI-75 at Week 16
• Adverse Event (AE) / Serious Adverse Event (SAE) Incidence Rate through study completion [ Time Frame: Screening through study completion, up to 24 weeks ]
  Incidence of AEs and SAEs

Current Secondary Outcome Measures (submitted: December 8, 2022)

• Static Physician's Global Assessment (sPGA) Efficacy at 16 weeks [ Time Frame: Day 1 of Placebo-controlled treatment period to week 16 ]
  Proportion of participants achieving a sPGA score of 0 (clear) or 1 (almost clear) at Week 16
• PASI Efficacy at 16 weeks [ Time Frame: Day 1 of Placebo-controlled treatment period to week 16 ]
  Change and percent change from baseline in PASI at Week 16
• PASI Efficacy at 16 weeks [ Time Frame: Day 1 of Placebo-controlled treatment period to week 16 ]
  Proportion of participants achieving PASI-90 at Week 16
• PASI Efficacy at 16 weeks [ Time Frame: Day 1 of Placebo-controlled treatment period to week 16 ]
  Proportion of participants achieving PASI-100 at Week 16
• Dermatology Life Quality Index (DLQI) Efficacy at 16 weeks [ Time Frame: Day 1 of Placebo-controlled treatment period to week 16 ]
  Change from baseline in DLQI scores at Week 16
• Body Surface Area (BSA) Efficacy at 16 weeks [ Time Frame: Day 1 of Placebo-controlled treatment period to week 16 ]
  Change from baseline in BSA at Week 16

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: VTX958 Versus Placebo for the Treatment of Moderate to Severe Psoriasis
• Official Title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VTX958 in Participants With Moderate to Severe Psoriasis

Brief Summary

This is a study to understand if taking VTX958 is safe and effective in participants diagnosed with moderate to severe psoriasis (PsO). Approximately 200 patients will take VTX958 Dose A, VTX958 Dose B, VTX958 Dose C, VTX958 Dose D, or placebo.

The study consists of a 30-day Screening Period (to see if a participant qualifies for the study), a 16-week double-blind period (a participant receives active Dose A, Dose B, Dose C, Dose D, or placebo), a 16-week Long Term Extension (LTE) period, a 36-week Open Label Extension (OLE) period and a 4-week Follow-Up Period. The maximal duration of treatment will be 17 months.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

The study will employ a double-blind design. Subjects, Investigators, study center staff, persons performing the assessments, and the Sponsor are to remain blinded to the identity of the Treatment Period from the time of randomization until the database lock for the study.

Primary Purpose: Treatment

• Condition: Psoriasis

Intervention

• Drug: VTX958
  Dose A
• Drug: VTX958
  Dose B
• Drug: VTX958
  Dose C
• Drug: VTX958
  Dose D
• Drug: Placebo
  Placebo

Study Arms

• Experimental: VTX958 Dose A
  Intervention: Drug: VTX958
• Experimental: VTX958 Dose B
  Intervention: Drug: VTX958
• Experimental: VTX958 Dose C
  Intervention: Drug: VTX958
• Experimental: VTX958 Dose D
  Intervention: Drug: VTX958
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: October 18, 2023): 222
• Original Estimated Enrollment (submitted: December 8, 2022): 200
• Actual Study Completion Date: December 20, 2023
• Actual Primary Completion Date: September 13, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Male or female participant aged 18 years or older.
• History of primarily plaque psoriasis for at least 6 months prior to the screening visit.
• Has had stable psoriasis conditions for at least 3 months before screening.
• 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.
• Has plaque psoriasis covering ≥ 10% of the total BSA at screening and Day 1.
• Deemed by the investigator to be eligible for phototherapy or systemic therapy.
• 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.

Exclusion Criteria:

• Female who is breastfeeding, pregnant, lactating, or who is planning to become pregnant during the study.
• Has evidence of erythrodermic, pustular, predominantly inverse or guttate psoriasis, or drug-induced psoriasis.
• History of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the study assessments.
• Participant is known to have immune deficiency or is immunocompromised.
• 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.

• Has used any topical medication that could affect psoriasis (including corticosteroids, retinoids, vitamin D analogues [such as calcipotriol], Janus kinase [JAK] inhibitors, or tar) within 2 weeks prior to Day 1.
• 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.

• Participant has received any ultraviolet B (UVB) phototherapy (including tanning beds) or excimer laser within 4 weeks prior to Day 1.
• Participant has had psoralen and ultraviolet A (PUVA) treatment within 4 weeks prior to Day 1.
• Participant has received treatment with an investigational or marketed TYK2 inhibitor.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, Poland, United States

Administrative Information

• NCT Number: NCT05655299
• Other Study ID Numbers: VTX958-201
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Ventyx Biosciences, Inc
• Original Responsible Party: Same as current
• Current Study Sponsor: Ventyx Biosciences, Inc
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Snehal Naik, PhD; Ventyx Biosciences, Inc

• PRS Account: Ventyx Biosciences, Inc
• Verification Date: December 2023