NCT05478499

Efficacy and Safety of Deucravacitinib Versus Placebo in Participants With Moderate-to-severe Scalp Psoriasis

Completed Phase 4 Results posted Last updated 28 October 2025

What this trial tests

Phase 4 trial testing Deucravacitinib in Psoriasis in 154 participants. Completed in 17 October 2024.

Timeline

6 October 2022

Primary endpoint
11 January 2024

17 October 2024

Quick facts

Lead sponsor	Bristol-Myers Squibb
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	154
Start date	6 October 2022
Primary completion	11 January 2024
Estimated completion	17 October 2024
Sites	29 locations across France, United Kingdom, Germany, Poland, United States

Drugs / interventions tested

• Deucravacitinib (DEUCRAVACITINIB) — full drug profile →
• Placebo

Conditions studied

• Psoriasis — all drugs for Psoriasis →

Sponsor

Bristol-Myers Squibb — full company profile →

Who can join

18 and older, any sex, with Psoriasis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With a Scalp-specific Physician Global Assessment Score of 0 or 1 (Ss-PGA 0/1) at Week 16 Primary · Baseline and Week 16

ss-PGA 0/1 response as a percentage of participants with an ss-PGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16. Scalp lesions are evaluated in terms of clinical signs of redness, thickness, and scaliness and scored on the following 5-point ss-PGA scale: 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, 4 = severe disease.

Full Analysis Set

Group	Value	95% CI
Deucravacitinib	48.5	38.6 – 58.6
Placebo	13.7	5.7 – 26.3

Patient sub-population (s-PGA ≥ 3)

Group	Value	95% CI
Deucravacitinib	50.0	39.6 – 60.4
Placebo	12.8	4.8 – 25.7

Percentage of Participants With a Psoriasis Scalp Severity Index 90 (PSSI 90) at Week 16 Secondary · Baseline and Week 16

PSSI 90 response as a percentage of participants who achieve at least 90% improvement from baseline in the PSSI score at Week 16. PSSI assesses severity of scalp disease in participants with scalp involvement with a 5-point Likert-type scale on the clinical parameters of erythema, induration, and desquamation. The scores are summed and multiplied by an integer (0 to 6) that represents the area of affected scalp. The PSSI score ranges from 0 to 72 with higher scores indicating more severe symptoms.

Full Analysis Set

Group	Value	95% CI
Deucravacitinib	38.8	29.4 – 48.9
Placebo	2.0	NA – 10.4

Patient sub-population (s-PGA ≥ 3)

Group	Value	95% CI
Deucravacitinib	40.6	30.7 – 51.1
Placebo	2.1	NA – 11.3

Change From Baseline in Scalp-specific Itch Numerical Rating Scale (NRS) Score at Week 16 Secondary · Baseline and Week 16

Change from baseline in scalp-specific itch numerical rating scale (NRS) score at week 16. The scalp-specific itch NRS is an 11-point horizontal scale anchored at 0 and 10 with 0 representing "no scalp itch" and 10 representing "worst scalp itch imaginable.". Overall severity of a participant's itching from scalp psoriasis is indicated by selecting the number that best describes the worst level of scalp itching within the past 24 hours.

Full Analysis Set

Group	Value	95% CI
Deucravacitinib	-3.2	± 2.95
Placebo	-0.7	± 2.27

Patient sub-population (s-PGA ≥ 3)

Group	Value	95% CI
Deucravacitinib	-3.3	± 2.87
Placebo	-0.9	± 2.29

Percentage of Participants With a Static Physician Global Assessment Score of 0 or 1 (s-PGA 0/1) at Week 16 Secondary · Baseline and Week 16

s-PGA 0/1 response as a percentage of participants with an s-PGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16. The s-PGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. The s-PGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as clear (0), almost clear (1), mild (2), moderate (3), or severe (4).

Group	Value	95% CI
Deucravacitinib	51.0	40.6 – 61.4
Placebo	4.3	0.5 – 14.5

Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) Secondary · From week 0 through week 16

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relation with this treatment.

Group	Value	95% CI
Deucravacitinib	73
Placebo	26

Number of Participants Experiencing Serious Treatment Emergent Adverse Events (TEAEs) Secondary · From week 0 through week 16

A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization.

Group	Value	95% CI
Deucravacitinib	1
Placebo	1

Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade Secondary · Week 0 through Week 16

Laboratory test results summary of Worst toxicity grade in SI units for hematology and chemistry using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Grade 1= mild and asymptomatic; Grade 2= moderate requiring minimal, local or noninvasive intervention; Grade 3= severe or medically significant but not immediately life-threatening; Grade 4= events are usually severe enough to require hospitalization.

Basophils (10^9/L) Grade 1-4

Group	Value	95% CI
Deucravacitinib	0
Placebo	0

Eosinophils (10^9/L) Grade 1

Group	Value	95% CI
Deucravacitinib	4
Placebo	2

Eosinophils (10^9/L) Grade 2-4

Group	Value	95% CI
Deucravacitinib	0
Placebo	0

Hemoglobin (g/L) Grade 1

Group	Value	95% CI
Deucravacitinib	5
Placebo	4

Hemoglobin (g/L) Grade 2

Group	Value	95% CI
Deucravacitinib	1
Placebo	0

Hemoglobin (g/L) Grade 3

Group	Value	95% CI
Deucravacitinib	0
Placebo	0

Leukocytes (10^9/L) Grade 1

Group	Value	95% CI
Deucravacitinib	8
Placebo	1

Leukocytes (10^9/L) Grade 2

Group	Value	95% CI
Deucravacitinib	0
Placebo	1

Number of Participants Experiencing Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests Secondary · Week 0 through Week 16

Number of participants with laboratory abnormalities in potential drug-induced liver injury tests. ALT=alanine aminotransferase AST=aspartate aminotransferase ULN=upper limit of normal

ALT or AST > 3 X ULN

Group	Value	95% CI
Deucravacitinib	0
Placebo	1

ALT or AST > 5 X ULN

Group	Value	95% CI
Deucravacitinib	0
Placebo	0

Total Bilirubin > 2 X ULN

Group	Value	95% CI
Deucravacitinib	0
Placebo	0

ALT or AST > 3 X ULN and total bilirubin > 2 X ULN on the same day

Group	Value	95% CI
Deucravacitinib	0
Placebo	0

Number of Participants With Abnormalities in Vital Signs Secondary · Week 0 through Week 16

Number of participants with abnormalities in vital signs including heart rate, systolic blood pressure, and diastolic blood pressure.

HEART RATE (BEATS/MIN): VALUE > 100 AND CHANGE FROM BASELINE > 30

Group	Value	95% CI
Deucravacitinib	0
Placebo	0

HEART RATE (BEATS/MIN): VALUE < 55 AND CHANGE FROM BASELINE < -15

Group	Value	95% CI
Deucravacitinib	1
Placebo	3

HEART RATE (BEATS/MIN): NOT REPORTED

Group	Value	95% CI
Deucravacitinib	0
Placebo	0

SYSTOLIC BLOOD PRESSURE (MMHG): VALUE > 140 AND CHANGE FROM BASELINE > 20

Group	Value	95% CI
Deucravacitinib	3
Placebo	4

SYSTOLIC BLOOD PRESSURE (MMHG): VALUE < 90 AND CHANGE FROM BASELINE < -20

Group	Value	95% CI
Deucravacitinib	0
Placebo	0

SYSTOLIC BLOOD PRESSURE (MMHG): NOT REPORTED

Group	Value	95% CI
Deucravacitinib	0
Placebo	0

DIASTOLIC BLOOD PRESSURE (MMHG): VALUE > 90 AND CHANGE FROM BASELINE > 10

Group	Value	95% CI
Deucravacitinib	8
Placebo	3

DIASTOLIC BLOOD PRESSURE (MMHG): VALUE < 55 AND CHANGE FROM BASELINE < -10

Group	Value	95% CI
Deucravacitinib	0
Placebo	2

Adverse events — posted to ClinicalTrials.gov

Time frame: Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo Controlled - Deucravacitinib

Serious: 1/103 (1%)

Deaths: 0/103

Placebo Controlled - Placebo

Serious: 1/51 (2%)

Deaths: 0/51

Active Treatment - Deucravacitinib - Deucravacitinib

Serious: 4/94 (4%)

Deaths: 1/94

Active Treatment - Placebo - Deucravacitinib

Serious: 0/45 (0%)

Deaths: 0/45

Serious adverse events (6 terms)

Reaction	System	Placebo Controlled - Deucr…	Placebo Controlled - Placebo	Active Treatment - Deucrav…	Active Treatment - Placebo…
Atrial fibrillation	Cardiac disorders	—	—	—	—
Myocardial infarction	Cardiac disorders	—	—	—	—
Meniscus injury	Injury, poisoning and procedural complications	—	—	—	—
Ligament disorder	Musculoskeletal and connective tissue disorders	—	—	—	—
Colorectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—	—	—	—

Other adverse events (7 terms — click to expand)

Reaction	System	Placebo Controlled - Deucr…	Placebo Controlled - Placebo	Active Treatment - Deucrav…	Active Treatment - Placebo…
Nasopharyngitis	Infections and infestations	—	—	—	—
COVID-19	Infections and infestations	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—
Acne	Skin and subcutaneous tissue disorders	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Acne pustular	Infections and infestations	—	—	—	—
Psoriasis	Skin and subcutaneous tissue disorders	—	—	—	—

Most-reported serious reactions: Atrial fibrillation, Myocardial infarction, Meniscus injury, Ligament disorder, Colorectal adenocarcinoma, Pulmonary embolism.

Data from ClinicalTrials.gov NCT05478499 adverse events section.

Sponsor's own description

The purpose of this study is to compare the efficacy and safety of deucravacitinib to placebo in participants with moderate-to-severe scalp psoriasis.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Deuterium in drug discovery: progress, opportunities and challenges.
   Di Martino RMC, Maxwell BD, Pirali T. · · 2023 · cited 228× · PMID 37277503 · DOI 10.1038/s41573-023-00703-8
2. JAK/STAT pathway: Extracellular signals, diseases, immunity, and therapeutic regimens.
   Hu Q, Bian Q, Rong D, Wang L, et al · · 2023 · cited 190× · PMID 36911202 · DOI 10.3389/fbioe.2023.1110765
3. Deucravacitinib: First Approval.
   Hoy SM. · · 2022 · cited 113× · PMID 36401743 · DOI 10.1007/s40265-022-01796-y
4. Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.
   Sbidian E, Chaimani A, Guelimi R, Garcia-Doval I, et al · · 2023 · cited 67× · PMID 37436070 · DOI 10.1002/14651858.cd011535.pub6
5. Tyk2 Targeting in Immune-Mediated Inflammatory Diseases.
   Rusiñol L, Puig L. · · 2023 · cited 54× · PMID 36834806 · DOI 10.3390/ijms24043391
6. SOCS-JAK-STAT inhibitors and SOCS mimetics as treatment options for autoimmune uveitis, psoriasis, lupus, and autoimmune encephalitis.
   Pandey R, Bakay M, Hakonarson H. · · 2023 · cited 45× · PMID 38022642 · DOI 10.3389/fimmu.2023.1271102
7. Allosteric TYK2 inhibition: redefining autoimmune disease therapy beyond JAK1-3 inhibitors.
   Jensen LT, Attfield KE, Feldmann M, Fugger L. · · 2023 · cited 45× · PMID 37863021 · DOI 10.1016/j.ebiom.2023.104840
8. New and Emerging Oral/Topical Small-Molecule Treatments for Psoriasis.
   Carmona-Rocha E, Rusiñol L, Puig L. · · 2024 · cited 28× · PMID 38399292 · DOI 10.3390/pharmaceutics16020239