Efficacy and Safety of Deucravacitinib Compared with Placebo in Participants with Active Psoriatic Arthritis (PsA) who are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Bristol-Myers Squibb Services Unlimited Company

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

20 Oct 2021 → ongoing

Decision date (initial)

2024-02-13

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Bristol-Myers Squibb International Corporation

External identifiers

EU CT number

2023-506256-25-00

EudraCT number

2020-005097-10

WHO UTN

U1111-1259-9443

ClinicalTrials.gov

NCT04908202

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety, Pharmacodynamic, Pharmacokinetic, Efficacy

To compare the efficacy of deucravacitinib to placebo in the treatment of
participants with active PsA

Secondary objectives 9

1. To compare the efficacy of deucravacitinib to placebo at Week 16 as assessed by DAS28-CRP
2. To compare the efficacy of deucravacitinib to placebo as assessed by HAQ-DI score at Week 16
3. To compare the efficacy of deucravacitinib to placebo as assessed by PASI 75 response at Week 16
4. To compare the efficacy of deucravacitinib to placebo as assessed by SF-36 PCS score at Week 16
5. To compare the efficacy of deucravacitinib to placebo in enthesitis resolution at Week 16
6. To compare the efficacy of deucravacitinib to placebo in MDA response at Week 16
7. To compare the efficacy of deucravacitinib to placebo in FACIT-Fatigue score at Week 16
8. To compare the efficacy of deucravacitinib to placebo in dactylitis resolution at Week 16
9. To compare the efficacy of deucravacitinib to placebo as assessed by structural damage at Week 16

Conditions and MedDRA coding

Active Psoriatic Arthritis

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Diagnosed to have psoriatic arthritis (PsA) of at least 3 months duration at screening
2. Meets the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria at Screening
3. Active plaque psoriatic skin lesion(s) or documented medical history of plaque psoriasis (PsO) at screening
4. Active arthritis as shown by ≥ 3 swollen joints and ≥ 3 tender joints at Screening and day 1
5. Participant has high sensitivity C-reactive protein (hsCRP) ≥ 3 mg/L at Screening
6. ≥ 1 PsA-related hand and/or foot joint erosion on X-ray during Screening Period that is confirmed by central reading

Exclusion criteria 6

1. Nonplaque psoriasis at screening or day 1
2. Other autoimmune condition such as systemic lupus erythematous, mixed connective tissue disease,multiple sclerosis, or vasculitis
3. History of or current inflammatory joint disease other than PsA (e.g., gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease)
4. Active fibromyalgia
5. Received an approved or investigational biologic therapy for the treatment of PsA or PsO
6. Participant has received a JAK inhibitor for the treatment of PsA and/or PsO.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of participants meeting American College of Rheumatology improvement of 20% (ACR 20) response at Week 16

Secondary endpoints 9

1. Change from baseline in DAS28-CRP score at Week 16
2. Change from baseline in HAQ-DI score at Week 16
3. Proportion of participants meeting PASI 75 response at Week 16, in participants with at least 3% BSA involvement AND at least sPGA 2 at baseline
4. Change from baseline in the SF-36 PCS score at Week 16
5. Proportion of participants meeting enthesitis resolution (score of 0) among participants with enthesitis at baseline by LEI at Week 16
6. Proportion of participants meeting achievement of MDA where an MDA response is achievement of 5 of 7 following outcomes at Week 16: a) Tender joint count ≤ 1 b) Swollen joint count ≤ 1 c) PASI ≤ 1 or BSA ≤ 3% d) Patient assessment of PsA pain ≤ 15 e) Patient Global Assessment of PsA disease activity ≤ 20 f) HAQ-DI ≤ 0.5 g) Tender enthesial points ≤ 1
7. Change from baseline in FACIT-Fatigue score at Week 16
8. Proportion of participants meeting dactylitis resolution at Week 16 among the participants with dactylitis at baseline, where resolution is defined as a tender dactylitis count of 0 in participants with a tender dactylitis count ≥ 1 at baseline
9. Change from baseline in PsA-modified SvdH score at Week 16

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bristol-Myers Squibb Services Unlimited Company

Sponsor organisation

Bristol-Myers Squibb Services Unlimited Company

Address

Plaza 254, Blanchardstown Corporate Park 2 Blanchardstown Corporate Park 2

City

Dublin 15

Postcode

D15 T867

Country

Ireland

Scientific contact point

Organisation

Bristol-Myers Squibb Services Unlimited Company

Contact name

GSM-CT

Public contact point

Organisation

Bristol-Myers Squibb Services Unlimited Company

Contact name

GSM-CT

Third parties 10

Locations

10 EU/EEA countries · 81 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 118 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

18 submissions — initial application plus substantial / non-substantial modifications