PsoriasisPhase 2Serenity PsONCT05655299
VTX958 Versus Placebo for the Treatment of Moderate to Severe Psoriasis
A Phase 2 study testing VTX958 Dose A, VTX958 Dose B and VTX958 Dose C in people with Psoriasis, run by Ventyx Biosciences, Inc at 63 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- VTX958 Dose A, VTX958 Dose B and VTX958 Dose C
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 222 participants
- Where
- 63 sitesin 3 countries
- Study dates
- 17 Nov 2022to 20 Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
63 sites in 3 countries.
63 sites in 3 countries
United States38 sites
Local Site # 840016
Bay City, Michigan, 48706
Local Site # 840012
Birmingham, Alabama, 35205
Local Site # 840006
Birmingham, Alabama, 35244
Local Site # 840040
Boca Raton, Florida, 33486
Local Site # 840008
Brighton, Massachusetts, 02135
Local Site # 840032
Bryant, Arkansas, 72022
Local Site # 840035
Clarksville, Indiana, 47129
Local Site # 840011
Doral, Florida, 33122
Local Site # 840007
Fort Gratiot, Michigan, 48059
Local Site # 840031
Fountain Valley, California, 92708
Local Site # 840023
Hialeah, Florida, 33012
Local Site # 840005
Indianapolis, Indiana, 46250
Local Site # 840026
Lomita, California, 90717
Local Site # 840013
Louisville, Kentucky, 40241
Local Site # 840029
Marietta, Georgia, 30060
Local Site # 840037
Mason, Ohio, 45040
Local Site # 840021
Miami Lakes, Florida, 33104
Local Site # 840015
Murfreesboro, Tennessee, 37130
Local Site # 840034
New Brighton, Minnesota, 55112
Local Site # 840041
North Little Rock, Arkansas, 72117
Local Site # 840044
North Miami Beach, Florida, 33162
Local Site # 840010
Ocala, Florida, 34470
Local Site # 840039
Pflugerville, Texas, 78660
Local Site # 840028
Phoenix, Arizona, 85032
Local Site # 840030
Plainfield, Indiana, 46168
Local Site # 840009
Portland, Oregon, 97223
Local Site # 840027
Portsmouth, New Hampshire, 03801
Local Site # 840038
Rapid City, South Dakota, 57702
Local Site # 840022
Rockville, Maryland, 20850
Local Site # 840024
Saint Joseph, Missouri, 64506
Local Site # 840019
Santa Rosa, California, 95405
Local Site # 840003
Sherman Oaks, California, 91403
Local Site # 840014
Spokane, Washington, 99202
Local Site # 840004
Tampa, Florida, 33607
Local Site # 840001
Tampa, Florida, 33613
Local Site # 840002
Troy, Michigan, 48084
Local Site # 840045
West Palm Beach, Florida, 33406
Local Site # 840042
Wilmington, North Carolina, 28405
Poland16 sites
Local Site # 616015
Bialystok
Local Site # 616016
Bialystok
Local Site # 616001
Katowice
Local Site # 616014
Krakow
Local Site # 616004
Lodz
Local Site #616010
Lublin
Local Site # 616011
Mikołów
Local Site # 616009
Nowa Sól
Local Site # 616003
Ostrowiec Świętokrzyski
Local Site # 616008
Poznan
Local Site # 616007
Szczecin
Local Site # 616013
Szczecin
Local Site # 616005
Warsaw
Local Site # 616002
Wroclaw
Local Site # 616006
Wroclaw
Local Site # 616018
Wroclaw
Canada9 sites
Local Site # 124012
Fredericton
Local Site # 124010
Mississauga
Local Site # 124002
Montreal
Local Site # 124004
North Bay
Local Site # 124011
Oshawa
Local Site # 124007
Peterborough
Local Site # 124008
Québec
Local Site # 124005
Toronto
Local Site # 124006
Windsor
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 Participants With Moderate to Severe Psoriasis
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 approximately 16 months.
- Conditions
- Psoriasis
- Being tested
- VTX958 Dose A, VTX958 Dose B, VTX958 Dose C, VTX958 Dose D, Placebo
- Keywords
- TYK2 inhibitor, moderate to severe psoriasis, Ventyx, VTX958
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VTX958 Dose ADrug
Dose A
VTX958 Dose BDrug
Dose B
VTX958 Dose CDrug
Dose C
VTX958 Dose DDrug
Dose D
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| VTX958 Dose A | Experimental | Not described Receives: Drug: VTX958 Dose A |
| VTX958 Dose B | Experimental | Not described Receives: Drug: VTX958 Dose B |
| VTX958 Dose C | Experimental | Not described Receives: Drug: VTX958 Dose C |
| VTX958 Dose D | Experimental | Not described Receives: Drug: VTX958 Dose D |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psoriasis Area and Severity Index (PASI) Efficacy at 16 weeks
Proportion of subjects achieving PASI-75 at Week 16
Measured: Day 1 of Placebo-controlled treatment period to week 16
Adverse Event (AE) / Serious Adverse Event (SAE) Incidence Rate through study completion
Incidence of AEs and SAEs
Measured: Screening through study completion, up to 76 weeks
Secondary outcomes (6)
Static Physician's Global Assessment (sPGA) Efficacy at 16 weeks
Proportion of participants achieving a sPGA score of 0 (clear) or 1 (almost clear) at Week 16
Measured: Day 1 of Placebo-controlled treatment period to week 16
PASI Efficacy at 16 weeks
Change and percent change from baseline in PASI at Week 16
Measured: Day 1 of Placebo-controlled treatment period to week 16
PASI Efficacy at 16 weeks
Proportion of participants achieving PASI-90 at Week 16
Measured: Day 1 of Placebo-controlled treatment period to week 16
PASI Efficacy at 16 weeks
Proportion of participants achieving PASI-100 at Week 16
Measured: Day 1 of Placebo-controlled treatment period to week 16
Dermatology Life Quality Index (DLQI) Efficacy at 16 weeks
Change from baseline in DLQI scores at Week 16
Measured: Day 1 of Placebo-controlled treatment period to week 16
Body Surface Area (BSA) Efficacy at 16 weeks
Change from baseline in BSA at Week 16
Measured: Day 1 of Placebo-controlled treatment period to week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start17 Nov 2022
- Primary completion25 Sep 2023
- Study completion20 Dec 2023
Why it stopped: Business Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ventyx Biosciences, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Snehal Naik, PhD, Study director, Ventyx Biosciences, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05655299
- Sponsor's protocol ID
- VTX958-201
- Acronym
- Serenity PsO
- Status last verified
- Sep 2024
- First submitted
- 2 Dec 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 Sep 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 Participants With Moderate to Severe Psoriasis
- ClinicalTrials.gov ID
- NCT05655299
- Acronym / sponsor ID
- Serenity PsO / VTX958-201
- Conditions
- Psoriasis
- Keywords
- TYK2 inhibitor, moderate to severe psoriasis, Ventyx, VTX958
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business Decision
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Ventyx Biosciences, IncIndustry (pharma, biotech, devices)
- Study start
- 17 Nov 2022 (actual)
- Primary completion
- 25 Sep 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 19 Dec 2022 (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.
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 approximately 16 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| VTX958 Dose A | Experimental | Drug: VTX958 Dose A |
| VTX958 Dose B | Experimental | Drug: VTX958 Dose B |
| VTX958 Dose C | Experimental | Drug: VTX958 Dose C |
| VTX958 Dose D | Experimental | Drug: VTX958 Dose D |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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).
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 |
|---|---|---|
| VTX958 Dose ADose A | Drug | VTX958 Dose A |
| VTX958 Dose BDose B | Drug | VTX958 Dose B |
| VTX958 Dose CDose C | Drug | VTX958 Dose C |
| VTX958 Dose DDose D | Drug | VTX958 Dose D |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
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
6 secondary outcomes
Static Physician's Global Assessment (sPGA) Efficacy at 16 weeks
Time frame: Day 1 of Placebo-controlled treatment period to week 16
PASI Efficacy at 16 weeks
Time frame: Day 1 of Placebo-controlled treatment period to week 16
PASI Efficacy at 16 weeks
Time frame: Day 1 of Placebo-controlled treatment period to week 16
PASI Efficacy at 16 weeks
Time frame: Day 1 of Placebo-controlled treatment period to week 16
Dermatology Life Quality Index (DLQI) Efficacy at 16 weeks
Time frame: Day 1 of Placebo-controlled treatment period to week 16
Body Surface Area (BSA) Efficacy at 16 weeks
Time frame: Day 1 of Placebo-controlled treatment period to week 16
Results and safety
The study was stopped early (reason given: Business Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 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.
Snehal Naik, PhD study director
Ventyx Biosciences, Inc
63 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VTX958 Dose A, VTX958 Dose B and VTX958 Dose C in people with Psoriasis, run by Ventyx Biosciences, Inc at 63 sites in 3 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 7 inclusion and 12 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 63 sites in United States, Poland, Canada. 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: Business 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?
Psoriasis Area and Severity Index (PASI) Efficacy at 16 weeks (time frame: Day 1 of Placebo-controlled treatment period to 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 19 Sep 2024.