Back to resultsVTX958 Versus Placebo for the Treatment of Active Psoriatic Arthritis (Tranquility-PsA)
Primary Purpose
Psoriatic Arthritis
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Dose A VTX958
Dose B VTX958
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Psoriatic Arthritis focused on measuring TYK2 inhibitor, Psoriatic arthritis, Ventyx, VTX958, Tranquility
Eligibility Criteria
Inclusion Criteria: Diagnosed with Psoriatic Arthritis for 6 months or more prior to Screening Documented history or active signs of at least 1 confirmed lesion of plaque psoriasis and/or nail changes attributed to psoriasis Active PsA as defined by 3 or more swollen joints and 3 or more tender joints at Screening and Day 1 Women must not be of childbearing potential or must agree to use a highly effective contraception during the study and for 30 days after the last dose of the study product Men with a partner who is of childbearing potential must agree to use condoms during the study and for 90 days after the last dose of study product Exclusion Criteria: Has non-plaque psoriasis at Screening or Day 1 Has inflammatory bowel disease or active uveitis Has a history of chronic or recurrent infectious disease Has a known immune deficiency or is immunocompromised Has hepatitis B or hepatitis C infection, human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), or active tuberculosis (TB) at screening
Sites / Locations
- Site # 840001Recruiting
- Site # 840016Recruiting
- Site # 840004Recruiting
- Site # 840014Recruiting
- Site # 840017Recruiting
- Site # 840018Recruiting
- Site #840012Recruiting
- Site # 840019Recruiting
- Site # 840003Recruiting
- Site # 840007Recruiting
- Site # 840002
- Site # 840010Recruiting
- Site # 840006Recruiting
- Site # 840015Recruiting
- Site # 840011Recruiting
- Site # 840008Recruiting
- Site # 100004Recruiting
- Site # 100007Recruiting
- Site # 100001Recruiting
- Site # 100002Recruiting
- Site # 100005Recruiting
- Site # 100003Recruiting
- Site # 203004Recruiting
- Site # 203001Recruiting
- Site # 203003Recruiting
- Site # 203005Recruiting
- Site # 203002Recruiting
- Site # 276002Recruiting
- Site # 276001Recruiting
- Site # 348002Recruiting
- Site # 348003Recruiting
- Site # 348001Recruiting
- Site # 348004Recruiting
- Site # 616015Recruiting
- Site # 616007Recruiting
- Site # 616010Recruiting
- Site # 616013Recruiting
- Site # 616002Recruiting
- Site # 616011Recruiting
- Site # 616004Recruiting
- Site # 616008Recruiting
- Site # 616006Recruiting
- Site #616001Recruiting
- Site # 616003Recruiting
- Site # 616016Recruiting
- Site # 616009Recruiting
- Site # 616012Recruiting
- Site # 616014Recruiting
- Site # 724002Recruiting
- Site # 724005Recruiting
- Site # 724004Recruiting
- Site # 724003Recruiting
- Site # 724001Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
VTX958 Dose A
VTX958 Dose B
Arm Description
Outcomes
Primary Outcome Measures
Proportion of participants achieving 20% improvement in American College of Rheumatology criteria (ACR20) at Week 16
Number of participants reaching ACR20 at week 16, compared to the total number of participants in each cohort
Incidence of Treatment Emergent Adverse Events (TEAEs) from week 0 through week 16
The number and proportion of participants who have at least 1 TEAE after exposure to the study drug
Secondary Outcome Measures
Change from baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) scores at Week 16
HAQ-DI assesses functional ability. It is a 20 question instrument that assesses the degree of difficulty with accomplishing tasks in 8 functional areas (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty) to 3 (inability to perform a task in that area). The overall HAQ-DI score is the mean of the 8 functional area scores and ranges from 0 to 3. Lower scores are indicative of improved functional ability.
Proportion of participants achieving 75% reduction in the Psoriasis Area and Severity Index (PASI75) score at Week 16, in participants with at least 3% body surface area (BSA) involvement at baseline
PASI is used to assess the severity of psoriasis and response to therapy. Each body region is evaluated separately for body surface area percentage of involvement and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement) and for erythema, induration, and scaling, each is rated on scale of 0 to 4 (from none to maximum severity). PASI numeric scores range from 0 (no psoriasis) to 72 (maximal disease). Higher scores indicate more severe disease.
Change from baseline in Short Form Health Survey - 36 items (SF-36) physical component score (PCS) at Week 16
SF-36 is a 36-item, patient-reported measure of health status and quality of life, which includes 8 domains (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health). Each of the 8 domains contribute in different proportions to the physical component summary (PCS) score and the mental component summary (MCS) score, which are normalized to general US population norms and range from 0 to 100 (where higher scores correspond to a better quality of life).
Proportion of participants achieving 50% improvement in American College of Rheumatology criteria (ACR50) at Week 16
Number of participants reaching ACR50 at week 16, compared to the total number of participants in each cohort
Proportion of participants achieving 70% improvement in American College of Rheumatology criteria (ACR70) at Week 16
Number of participants reaching ACR70 at week 16, compared to the total number of participants in each cohort
Full Information
NCT ID
NCT05715125
First Posted
January 19, 2023
Last Updated
October 19, 2023
Sponsor
Ventyx Biosciences, Inc
1. Study Identification
Unique Protocol Identification Number
NCT05715125
Brief Title
VTX958 Versus Placebo for the Treatment of Active Psoriatic Arthritis (Tranquility-PsA)
Official Title
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VTX958 in Patients With Active Psoriatic Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2023 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
April 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ventyx Biosciences, Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to evaluate if VTX958 is safe and effective in adult participants with active Psoriatic Arthritis. Approximately 195 eligible participants will take VTX958 Dose A, VTX958 Dose B, or matching placebo (no active drug) for 16 weeks and then move on to a 36 week Long Term Extension (LTE). The study will include 16 weeks of treatment, 36 weeks of LTE, and a 30-day follow-up period.
Detailed Description
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two doses of VTX958 tablets, Dose A and Dose B, in adults with active Psoriatic Arthritis. Approximately 195 participants will be assigned in a 1:1:1 ratio to one of three groups, VTX958 Dose A, VTX958 Dose B, or placebo, for 16 weeks and then move on to a 36 week Long Term Extension (LTE). The study consists of a 30-day screening period, a 16 week double-blind treatment period, 36 weeks of LTE, and a 30 day follow-up period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriatic Arthritis
Keywords
TYK2 inhibitor, Psoriatic arthritis, Ventyx, VTX958, Tranquility
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomly assigned at the beginning of the study to either Dose A, Dose B, or placebo group, where they stay for the remainder of the study.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The study has a double-blind design, meaning that the participant, care provider, and investigator will not know what treatment group each participant has been assigned to. This blinding will last from randomization until the end of the study.
Allocation
Randomized
Enrollment
195 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
VTX958 Dose A
Arm Type
Experimental
Arm Title
VTX958 Dose B
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Dose A VTX958
Intervention Description
Dose A VTX958
Intervention Type
Drug
Intervention Name(s)
Dose B VTX958
Intervention Description
Dose B VTX958
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Proportion of participants achieving 20% improvement in American College of Rheumatology criteria (ACR20) at Week 16
Description
Number of participants reaching ACR20 at week 16, compared to the total number of participants in each cohort
Time Frame
Week 16
Title
Incidence of Treatment Emergent Adverse Events (TEAEs) from week 0 through week 16
Description
The number and proportion of participants who have at least 1 TEAE after exposure to the study drug
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Change from baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) scores at Week 16
Description
HAQ-DI assesses functional ability. It is a 20 question instrument that assesses the degree of difficulty with accomplishing tasks in 8 functional areas (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty) to 3 (inability to perform a task in that area). The overall HAQ-DI score is the mean of the 8 functional area scores and ranges from 0 to 3. Lower scores are indicative of improved functional ability.
Time Frame
Week 16
Title
Proportion of participants achieving 75% reduction in the Psoriasis Area and Severity Index (PASI75) score at Week 16, in participants with at least 3% body surface area (BSA) involvement at baseline
Description
PASI is used to assess the severity of psoriasis and response to therapy. Each body region is evaluated separately for body surface area percentage of involvement and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement) and for erythema, induration, and scaling, each is rated on scale of 0 to 4 (from none to maximum severity). PASI numeric scores range from 0 (no psoriasis) to 72 (maximal disease). Higher scores indicate more severe disease.
Time Frame
Week 16
Title
Change from baseline in Short Form Health Survey - 36 items (SF-36) physical component score (PCS) at Week 16
Description
SF-36 is a 36-item, patient-reported measure of health status and quality of life, which includes 8 domains (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health). Each of the 8 domains contribute in different proportions to the physical component summary (PCS) score and the mental component summary (MCS) score, which are normalized to general US population norms and range from 0 to 100 (where higher scores correspond to a better quality of life).
Time Frame
Week 16
Title
Proportion of participants achieving 50% improvement in American College of Rheumatology criteria (ACR50) at Week 16
Description
Number of participants reaching ACR50 at week 16, compared to the total number of participants in each cohort
Time Frame
Week 16
Title
Proportion of participants achieving 70% improvement in American College of Rheumatology criteria (ACR70) at Week 16
Description
Number of participants reaching ACR70 at week 16, compared to the total number of participants in each cohort
Time Frame
Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with Psoriatic Arthritis for 6 months or more prior to Screening
Documented history or active signs of at least 1 confirmed lesion of plaque psoriasis and/or nail changes attributed to psoriasis
Active PsA as defined by 3 or more swollen joints and 3 or more tender joints at Screening and Day 1
Women must not be of childbearing potential or must agree to use a highly effective contraception during the study and for 30 days after the last dose of the study product
Men with a partner who is of childbearing potential must agree to use condoms during the study and for 90 days after the last dose of study product
Exclusion Criteria:
Has non-plaque psoriasis at Screening or Day 1
Has inflammatory bowel disease or active uveitis
Has a history of chronic or recurrent infectious disease
Has a known immune deficiency or is immunocompromised
Has hepatitis B or hepatitis C infection, human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), or active tuberculosis (TB) at screening
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ventyx Clinical Trial Contact
Phone
888-411-5176
Ext
108
Email
clinicaltrials@ventyxbio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matt Cascino, MD
Organizational Affiliation
Ventyx Biosciences, Inc
Official's Role
Study Director
Facility Information:
Facility Name
Site # 840001
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Individual Site Status
Recruiting
Facility Name
Site # 840016
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Individual Site Status
Recruiting
Facility Name
Site # 840004
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Individual Site Status
Recruiting
Facility Name
Site # 840014
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Individual Site Status
Recruiting
Facility Name
Site # 840017
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Individual Site Status
Recruiting
Facility Name
Site # 840018
City
Okemos
State/Province
Michigan
ZIP/Postal Code
48864
Country
United States
Individual Site Status
Recruiting
Facility Name
Site #840012
City
Saint Clair Shores
State/Province
Michigan
ZIP/Postal Code
48081
Country
United States
Individual Site Status
Recruiting
Facility Name
Site # 840019
City
Eagan
State/Province
Minnesota
ZIP/Postal Code
55121
Country
United States
Individual Site Status
Recruiting
Facility Name
Site # 840003
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Individual Site Status
Recruiting
Facility Name
Site # 840007
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Individual Site Status
Recruiting
Facility Name
Site # 840002
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Individual Site Status
Withdrawn
Facility Name
Site # 840010
City
Baytown
State/Province
Texas
ZIP/Postal Code
77521
Country
United States
Individual Site Status
Recruiting
Facility Name
Site # 840006
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Individual Site Status
Recruiting
Facility Name
Site # 840015
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Individual Site Status
Recruiting
Facility Name
Site # 840011
City
Beckley
State/Province
West Virginia
ZIP/Postal Code
25802
Country
United States
Individual Site Status
Recruiting
Facility Name
Site # 840008
City
South Charleston
State/Province
West Virginia
ZIP/Postal Code
25309
Country
United States
Individual Site Status
Recruiting
Facility Name
Site # 100004
City
Haskovo
ZIP/Postal Code
6300
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Site # 100007
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Site # 100001
City
Plovdiv
ZIP/Postal Code
4003
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Site # 100002
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Site # 100005
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Site # 100003
City
Sofia
ZIP/Postal Code
1680
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Site # 203004
City
Hlučín
ZIP/Postal Code
748 01
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Site # 203001
City
Ostrava
ZIP/Postal Code
702 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Site # 203003
City
Pardubice
ZIP/Postal Code
530 02
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Site # 203005
City
Praha 5
ZIP/Postal Code
150 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Site # 203002
City
Zlín
ZIP/Postal Code
760 01
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Site # 276002
City
Berlin
ZIP/Postal Code
12161
Country
Germany
Individual Site Status
Recruiting
Facility Name
Site # 276001
City
Hamburg
ZIP/Postal Code
20095
Country
Germany
Individual Site Status
Recruiting
Facility Name
Site # 348002
City
Budapest
ZIP/Postal Code
1026
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Site # 348003
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Site # 348001
City
Hódmezővásárhely
ZIP/Postal Code
6800
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Site # 348004
City
Kistarcsa
ZIP/Postal Code
2143
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Site # 616015
City
Gdynia
ZIP/Postal Code
81-338
Country
Poland
Individual Site Status
Recruiting
Facility Name
Site # 616007
City
Katowice
ZIP/Postal Code
40-081
Country
Poland
Individual Site Status
Recruiting
Facility Name
Site # 616010
City
Kraków
ZIP/Postal Code
30-727
Country
Poland
Individual Site Status
Recruiting
Facility Name
Site # 616013
City
Lublin
ZIP/Postal Code
20-582
Country
Poland
Individual Site Status
Recruiting
Facility Name
Site # 616002
City
Nadarzyn
ZIP/Postal Code
05-830
Country
Poland
Individual Site Status
Recruiting
Facility Name
Site # 616011
City
Olsztyn
ZIP/Postal Code
10-117
Country
Poland
Individual Site Status
Recruiting
Facility Name
Site # 616004
City
Poznań
ZIP/Postal Code
61-113
Country
Poland
Individual Site Status
Recruiting
Facility Name
Site # 616008
City
Toruń
ZIP/Postal Code
87-100
Country
Poland
Individual Site Status
Recruiting
Facility Name
Site # 616006
City
Warszawa
ZIP/Postal Code
00-874
Country
Poland
Individual Site Status
Recruiting
Facility Name
Site #616001
City
Warszawa
ZIP/Postal Code
03-291
Country
Poland
Individual Site Status
Recruiting
Facility Name
Site # 616003
City
Wrocław
ZIP/Postal Code
52-416
Country
Poland
Individual Site Status
Recruiting
Facility Name
Site # 616016
City
Wrocław
ZIP/Postal Code
53-224
Country
Poland
Individual Site Status
Recruiting
Facility Name
Site # 616009
City
Łódź
ZIP/Postal Code
90-265
Country
Poland
Individual Site Status
Recruiting
Facility Name
Site # 616012
City
Łódź
ZIP/Postal Code
90-436
Country
Poland
Individual Site Status
Recruiting
Facility Name
Site # 616014
City
Łódź
ZIP/Postal Code
91-495
Country
Poland
Individual Site Status
Recruiting
Facility Name
Site # 724002
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Site # 724005
City
Lleida
ZIP/Postal Code
25198
Country
Spain
Individual Site Status
Recruiting
Facility Name
Site # 724004
City
Málaga
ZIP/Postal Code
29009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Site # 724003
City
Mérida
ZIP/Postal Code
6800
Country
Spain
Individual Site Status
Recruiting
Facility Name
Site # 724001
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
VTX958 Versus Placebo for the Treatment of Active Psoriatic Arthritis (Tranquility-PsA)
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