> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/trial/long-term-safety-study-of-deucravacitinib-versus-ustekinumab-ae68522e-efcd-4977-a0b9-90e8bcee809a
> Record changed: 2026-10-13

# Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

NCT07116967

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116967)

Phase

Phase 3

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116967)

Recruitment status

Recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116967)

Participants

3,040

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116967)

Lead sponsor

Bristol-Myers Squibb

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116967)

Start date

2025-09-22

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116967)

Number of sites

402

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116967)

## Title and summary

**Summary**

A study to evaluate the long-term safety of Deucravacitinib versus Ustekinumab in participants with psoriasis

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116967)

**Short title**

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116967)

**Official title**

A Phase 3b/4 Multi-center, Randomized, Open-label, Long-term Safety Study of Deucravacitinib in Comparison to Ustekinumab in Participants With Moderate-to-Severe Plaque Psoriasis

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116967)

## Status and phase

**Control arm**

Active comparator

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116967)

**Registry reports results**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116967)

**Listing at source**

Listed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116967)

**Recruitment status**

Recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116967)

**Phase**

Phase 3

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116967)

**Study type**

Interventional

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116967)

## Dates

**Completion date**

2031-01-16

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116967)

**First posted**

2025-08-12

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116967)

**Registry last updated**

2026-08-21

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116967)

**Primary completion date**

2031-01-16

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116967)

**Start date**

2025-09-22

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116967)

## Size and sites

**Participants**

3,040

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116967)

**Participant count basis**

Estimated

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116967)

**Planned participants**

3,040

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116967)

**Protocol amendments**

0

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116967)

**Number of sites**

402

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116967)

## Sponsor and oversight

**Data monitoring committee**

Yes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116967)

**Registry sponsor category**

Industry

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116967)

**Lead sponsor**

Bristol-Myers Squibb

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116967)

**Source registry**

ClinicalTrials.gov

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116967)

## Identifiers

**Registry ID**

NCT07116967

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116967)

**ClinicalTrials.gov ID**

NCT07116967

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116967)

**Registry record**

Open registry record

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116967)

## Study design

**Allocation**

Randomised

**Model**

Parallel groups

**Purpose**

Treatment

**Masking**

No masking

Sources for study design

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116967)

## Outcomes

### Primary outcomes

1. Composite cardiovascular adjudicated 3-point major adverse cardiovascular event (MACE) plus coronary revascularization  
Timeframe: Up to 5 years  
MACE defined as non-fatal myocardial infarction \\\[MI\\\], nonfatal stroke, and cardiovascular death

### Secondary outcomes

1. Number of participants with non-fatal MI  
Timeframe: Up to 5 years
2. Number of participants with non-fatal stroke  
Timeframe: Up to 5 years
3. Death due to cardiovascular events  
Timeframe: Up to 5 years
4. Number of participants with coronary revascularization  
Timeframe: Up to 5 years
5. Number of participants with 3-point MACE (non-fatal MI, non-fatal stroke, and cardiovascular death)  
Timeframe: Up to 5 years
6. Number of participants with pulmonary embolism (PE)  
Timeframe: Up to 5 years
7. Number of participants with deep vein thrombosis (DVT)  
Timeframe: Up to 5 years
8. Number of participants with composite venous thromboembolism (VTE)  
Timeframe: Up to 5 years  
PE, DVT and retinal vein occlusion
9. Number of participants with arterial thromboembolic events (including retinal artery occlusion)  
Timeframe: Up to 5 years
10. Number of participants with heart failure (HF) requiring hospitalization or urgent visit  
Timeframe: Up to 5 years
11. Number of participants with Malignancy excluding non-melanoma skin cancer (NMSC)  
Timeframe: Up to 5 years
12. Number of participants with NMSC  
Timeframe: Up to 5 years
13. Number of participants with opportunistic infections  
Timeframe: Up to 5 years  
Opportunistic infections include tuberculosis and complicated herpes zoster (eg, disseminated herpes zoster, affecting more than 2 dermatomes, ophthalmic or meningoencephalopathic involvement, and other atypical presentations)
14. Number of participants with Serious AEs (SAEs)  
Timeframe: Up to 60 days after last dose
15. All-cause mortality  
Timeframe: Up to 60 days after last dose
16. AEs leading to permanent treatment discontinuation  
Timeframe: Up to 60 days after last dose
17. Change from baseline in liver function test  
Timeframe: Up to 60 days after last dose
18. Change from baseline in fasting lipid panel  
Timeframe: Up to 60 days after last dose

Sources for outcomes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116967)

## Eligibility

**Sex**

All

**Age groups**

Adults, Older adults

**Minimum age**

40 Years

**Healthy volunteers**

No

### Inclusion criteria

- Participants with moderate-to-severe plaque psoriasis:

  1. Deemed by the Investigator to be a candidate for phototherapy or systemic treatment for psoriasis, including ustekinumab;
  2. Have at least 1 of the following cardiovascular risk factors:
- Current cigarette smoker
- Diagnosis of hypertension
- Diagnosis of hyperlipidemia
- Diabetes mellitus type 1 or 2
- History of one or more of the following cardiovascular events: Coronary intervention (PCI) or coronary artery bypass grafting (CABG), myocardial infarction (heart attack), cardiac arrest, hospitalization for unstable angina, acute coronary syndrome, stroke, or transient ischemic attack
- Obesity
- Family history of premature coronary heart disease or sudden death in a first-degree male relative younger than 55 years of age or in a first-degree female relative younger than 65 years of age.

### Exclusion criteria

- Participants must not have recent history of 1 of the following cardiovascular events: MI, stroke, or coronary revascularization, or VTE within 90 days prior to Day 1.
- Participants must not have unstable CVD, defined as a recent clinical cardiovascular event (eg, unstable angina, rapid atrial fibrillation), or a cardiac hospitalization (eg, pacemaker implantation, HF) within 90 days prior to Day 1.
- Participants must not have evidence of active cancer or history of cancer (solid organ or hematologic malignancy including myelodysplastic syndrome) or lymphoproliferative disease within the previous 5 years (other than resected cutaneous basal cell or squamous cell carcinoma, or carcinoma of cervix in situ that has been treated with no evidence of recurrence).
- Other protocol define inclusion/exclusion criteria apply.

Sources for eligibility

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116967)

## Sites

- Local Institution - 0088Birmingham, United StatesNot yet recruiting
- Medical Dermatology Specialists - PhoenixPhoenix, United StatesRecruiting
- Saguaro Dermatology - PhoenixPhoenix, United StatesRecruiting
- Omni DermatologyPhoenix, United StatesRecruiting
- Alliance DermatologyPhoenix, United StatesRecruiting
- Local Institution - 0322Scottsdale, United StatesWithdrawn
- Local Institution - 0188Scottsdale, United StatesWithdrawn
- Scottsdale Clinical TrialsScottsdale, United StatesRecruiting
- Omni DermatologyTempe, United StatesRecruiting
- Clinical Trials Institute of Northwest ArkansasFayetteville, United StatesRecruiting
- Northwest Arkansas Clinical Trials Center (NWACTC), PLLCRogers, United StatesRecruiting
- California Dermatology & Clinical Research InstituteEncinitas, United StatesRecruiting
- T. Joseph Raoof MD IncEncino, United StatesRecruiting
- First OC Dermatology - Fountain ValleyFountain Valley, United StatesRecruiting
- Center For Dermatology Clinical Research, Inc.Fremont, United StatesRecruiting
- Marvel Clinical ResearchHuntington Beach, United StatesRecruiting
- Dermatology Research Associates - Howard Sofen, MDLos Angeles, United StatesRecruiting
- Wallace Skin & Body InstituteLos Angeles, United StatesRecruiting
- Northridge Clinical Trials - Elite Clinical NetworkNorthridge, United StatesRecruiting
- Cura Clinical Research - PalmdalePalmdale, United StatesRecruiting
- Pasadena Clinical TrialsPasadena, United StatesRecruiting
- Empire Clinical Research - PomonaPomona, United StatesRecruiting
- Integrative Skin Science and ResearchSacramento, United StatesRecruiting
- UC Davis Dermatology ClinicSacramento, United StatesRecruiting
- Local Institution - 0078San Diego, United StatesWithdrawn

And 377 more, listed on the interactive page.

Sources for sites

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116967)

## References

- Related resource (www.bms.com)  
Source: [www.bms.com](https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html)
- Related resource (www.bmsclinicaltrials.com)  
Source: [www.bmsclinicaltrials.com](https://www.bmsclinicaltrials.com/us/en/clinical-trials/NCT07116967.html)

### Other registry identifiers (3)

- 2023
- U1111-1291-5815
- 2023-503766-24

Sources for references

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07116967)

## Related records

### Drugs (2)

- [Deucravacitinib](https://trialight.com/data/asset/deucravacitinib-3033fa9d-d652-4397-81c1-5e76480167af.md)
- [Ustekinumab](https://trialight.com/data/asset/ustekinumab-323cb2e2-e906-4997-ac57-d82c7f7c399d.md)

### Lead sponsors (1)

- [Bristol-Myers Squibb](https://trialight.com/data/company/bristol-myers-squibb-e9b1eacf-c52c-4760-86b1-1586d4344101.md)

### Targets (4)

- [IL12A](https://trialight.com/data/target/il12a-f7e63dfd-cd53-5ed7-ab6b-30bc302a7278.md)
- [IL12B](https://trialight.com/data/target/il12b-92e53178-7b56-555c-ac6b-a1235d8fe7e5.md)
- [IL23A](https://trialight.com/data/target/il23a-e11f3992-27b4-5bef-9242-07ab6ac420e9.md)
- [TYK2](https://trialight.com/data/target/tyk2-b41bcab9-b384-5a30-9edf-ec61d7908e06.md)

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