Psoriatic ArthritisPhase 2NCT05715125
VTX958 Versus Placebo for the Treatment of Active Psoriatic Arthritis (Tranquility-PsA)
A Phase 2 study testing Dose A VTX958 and Dose B VTX958 in people with Psoriatic Arthritis, run by Ventyx Biosciences, Inc at 46 sites in 7 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- Dose A VTX958 and Dose B VTX958
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 205 participants
- Where
- 46 sitesin 7 countries
- Study dates
- 31 Jan 2023to 2 Jan 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
46 sites in 7 countries.
46 sites in 7 countries
United States15 sites
Site # 840010
Baytown, Texas, 77521
Site # 840011
Beckley, West Virginia, 25802
Site # 840004
Clearwater, Florida, 33765
Site # 840007
Duncansville, Pennsylvania, 16635
Site # 840019
Eagan, Minnesota, 55121
Site # 840017
Lexington, Kentucky, 40504
Site # 840006
Lubbock, Texas, 79410
Site # 840015
Mesquite, Texas, 75150
Site # 840014
Miami Lakes, Florida, 33014
Site # 840003
Middleburg Heights, Ohio, 44130
Site # 840016
Newport Beach, California, 92663
Site # 840018
Okemos, Michigan, 48864
Site # 840001
Phoenix, Arizona, 85032
Site #840012
Saint Clair Shores, Michigan, 48081
Site # 840008
South Charleston, West Virginia, 25309
Poland15 sites
Site # 616015
Gdynia, 81-338
Site # 616007
Katowice, 40-081
Site # 616010
Krakow, 30-727
Site # 616009
Lodz, 90-265
Site # 616012
Lodz, 90-436
Site # 616014
Lodz, 91-495
Site # 616013
Lublin, 20-582
Site # 616002
Nadarzyn, 05-830
Site # 616011
Olsztyn, 10-117
Site # 616004
Poznan, 61-113
Site # 616008
Torun, 87-100
Site # 616006
Warsaw, 00-874
Site #616001
Warsaw, 03-291
Site # 616003
Wroclaw, 52-416
Site # 616016
Wroclaw, 53-224
Czechia5 sites
Site # 203004
Hlučín, 748 01
Site # 203001
Ostrava, 702 00
Site # 203003
Pardubice, 530 02
Site # 203005
Prague, 150 00
Site # 203002
Zlín, 760 01
Bulgaria3 sites
Site # 100004
Haskovo, 6300
Site # 100001
Plovdiv, 4003
Site # 100002
Plovdiv, 4004
Hungary3 sites
Site # 348003
Budapest, 1036
Site # 348001
Hódmezővásárhely, 6800
Site # 348004
Kistarcsa, 2143
Spain3 sites
Site # 724002
A Coruña, 15006
Site # 724005
Lleida, 25198
Site # 724001
Seville, 41009
About this study
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
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.
Read the 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.
- Conditions
- Psoriatic Arthritis
- Being tested
- Dose A VTX958, Dose B VTX958, Placebo
- Keywords
- TYK2 inhibitor, Psoriatic arthritis, Ventyx, VTX958, Tranquility
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose A VTX958Drug
Dose A VTX958
Dose B VTX958Drug
Dose B VTX958
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| VTX958 Dose A | Experimental | Not described Receives: Drug: Dose A VTX958 |
| VTX958 Dose B | Experimental | Not described Receives: Drug: Dose B VTX958 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 16
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
Measured: Week 16
Secondary outcomes (5)
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.
Measured: Week 16
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.
Measured: Week 16
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).
Measured: Week 16
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
Measured: Week 16
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
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start31 Jan 2023
- Primary completion2 Jan 2024
- Study completion2 Jan 2024
Why it stopped: sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ventyx Biosciences, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matt Cascino, MD, Study director, Ventyx Biosciences, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05715125
- Sponsor's protocol ID
- VTX958-203
- Status last verified
- Dec 2024
- First submitted
- 19 Jan 2023
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05715125
- Acronym / sponsor ID
- VTX958-203
- Conditions
- Psoriatic Arthritis
- Keywords
- TYK2 inhibitor, Psoriatic arthritis, Ventyx, VTX958, Tranquility
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: sponsor decision
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Ventyx Biosciences, IncIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 2 Jan 2024 (actual)
- Study completion
- 2 Jan 2024 (actual)
- First posted
- 6 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| VTX958 Dose A | Experimental | Drug: Dose A VTX958 |
| VTX958 Dose B | Experimental | Drug: Dose B VTX958 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dose A VTX958Dose A VTX958 | Drug | VTX958 Dose A |
| Dose B VTX958Dose B VTX958 | Drug | VTX958 Dose B |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Proportion of participants achieving 20% improvement in American College of Rheumatology criteria (ACR20) at Week 16
Time frame: 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
Time frame: Week 16
The number and proportion of participants who have at least 1 TEAE after exposure to the study drug
5 secondary outcomes
Change from baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) scores at Week 16
Time frame: Week 16
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
Time frame: Week 16
Change from baseline in Short Form Health Survey - 36 items (SF-36) physical component score (PCS) at Week 16
Time frame: Week 16
Proportion of participants achieving 50% improvement in American College of Rheumatology criteria (ACR50) at Week 16
Time frame: Week 16
Proportion of participants achieving 70% improvement in American College of Rheumatology criteria (ACR70) at Week 16
Time frame: Week 16
Results and safety
The study was stopped early (reason given: sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matt Cascino, MD study director
Ventyx Biosciences, Inc
46 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dose A VTX958 and Dose B VTX958 in people with Psoriatic Arthritis, run by Ventyx Biosciences, Inc at 46 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in United States, Poland, Czechia, Bulgaria, Hungary and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: sponsor decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants achieving 20% improvement in American College of Rheumatology criteria (ACR20) at Week 16 (time frame: Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.