A Study to Determine the 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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04908202
• Collaborator: (none)
• Enrollment: 650
• Locations: 128
• Arms: 2
• Anticipated Duration (Months): 63
• Patients Per Site: 5.1
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of deucravacitinib versus placebo in participants with active psoriatic arthritis who are naïve to biologic disease-modifying anti-rheumatic drugs. The long term extension period will provide additional long-term efficacy and safety information.

Condition or Disease	Intervention/Treatment	Phase
Psoriatic Arthritis	Drug: Deucravacitinib; Other: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 650 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Active Psoriatic Arthritis Who Are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs
• Actual Study Start Date: Jul 13, 2021
• Anticipated Primary Completion Date: Jan 16, 2024
• Anticipated Study Completion Date: Oct 13, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Deucravacitinib	Drug: Deucravacitinib; Specified dose on specified days; Other Names: BMS-986165
Placebo Comparator: Placebo	Other: Placebo; Specified dose on specified days

Outcome Measures

Primary Outcome Measures

1. Proportion of participants meeting American College of Rheumatology improvement of 20% (ACR 20) response [At week 16]

Secondary Outcome Measures

1. Change from baseline in Disease Activity Score 28 with C-reactive protein (DAS28-CRP) score [At week 16]

2. Change from baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) score [At week 16]

3. Proportion of participants meeting Psoriatic Area and Severity Index (PASI) 75 response [At week 16]

4. Change from baseline in the Short Form-36 Physical Component Survey (SF-36 PCS) score [At week 16]

5. Proportion of participants meeting enthesitis resolution among participants with enthesitis at baseline by Leeds Enthesitis Index (LEI) [At week 16]

6. Proportion of participants meeting achievement of Minimal Disease Activity (MDA) [At week 16]

7. Change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score [At week 16]

8. Proportion of participants meeting dactylitis resolution at week 16 among the participants with dactylitis at baseline [At week 16]

9. Change from baseline in PsA-modified Sharp-van der Heijde (SvdH) score [At week 16]

10. Proportion of participants meeting ACR 20 response [Up to 16 weeks]

11. Proportion of participants meeting American College of Rheumatology improvement of 50% (ACR 50) response [Up to 16 weeks]

12. Proportion of participants meeting American College of Rheumatology improvement of 70% (ACR 70) response [Up to 16 weeks]

13. Change from baseline in HAQ-DI score [Up to 16 weeks]

14. Proportion of participants who achieve a clinically meaningful improvement (≥ 0.35 improvement from baseline) in HAQ-DI score among participants with a HAQ-DI score ≥ 0.35 at baseline [Up to 16 weeks]

15. Proportion of participants with achievement of PASI 75 response [Up to 16 weeks]

16. Proportion of participants with achievement of PASI 90 response [Up to 16 weeks]

17. Proportion of participants with achievement of PASI 100 response [Up to 16 weeks]

18. Change from baseline in the SF-36 PCS score [Up to 16 weeks]

19. Proportion of participants meeting enthesitis resolution among participants with enthesitis at baseline by LEI [Up to 16 weeeks]

20. Proportion of participants meeting enthesitis resolution among participants with enthesitis at baseline by Spondyloarthritis Research Consortium of Canada (SPARCC) [Up to 16 weeks]

21. Proportion of participants meeting achievement of MDA [Up to 16 weeks]

22. Change from baseline in SF-36 Mental Component Summary (MCS) score [Up to 16 weeks]

23. Change from baseline in FACIT-Fatigue score [Up to 16 weeks]

24. Proportion of participants meeting dactylitis resolution among the participants with dactylitis at baseline [Up to 16 weeks]

25. Change from baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 score [Up to 16 weeks]

26. Change from baseline in Disease Activity Index for Psoriatic Arthritis Score (DAPSA) score [Up to 16 weeks]

27. Proportion of participants with achievement of DAPSA low disease activity response [Up to 16 weeks]

28. Proportion of participants with achievement of DAPSA disease remission [Up to 16 weeks]

29. Proportion of participants meeting achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1 in participants with a baseline PGA-F score of ≥ 3 [Up to 16 weeks]

30. Change from baseline in DAS28-CRP score [Up to 16 weeks]

31. Proportion of participants with achievement of a DAS28-CRP low disease activity response [Up to 16 weeks]

32. Proportion of participants with achievement of a DAS28-CRP disease remission [Up to 16 weeks]

33. Change from baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) [Up to 16 weeks]

34. Change from baseline in modified Composite Psoriatic Disease Activity Index (mCPDAI) score [Up to 16 weeks]

35. Proportion of participants achieving Psoriatic Arthritis Response Criteria (PsARC) [Up to 16 weeks]

36. Proportion of participants meeting achievement of improvement from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score among participants with spondylitis in addition to peripheral joint involvement as their presentation of PsA [Up to 16 weeks]

37. Proportion of participants meeting achievement of total PsA-modified SvdH score of ≤ 0 [At week 16]

38. Proportion of participants meeting achievement of total PsA-modified SvdH score of ≤ 0.5 [At week 16]

39. Proportion of participants meeting achievement of total PsA-modified SvdH score of ≤ smallest detectable change (SDC) [At week 16]

40. Proportion of participants meeting achievement of PsA-modified SvdH erosion score change of ≤ 0 [At week 16]

41. Proportion of participants meeting achievement of PsA-modified SvdH erosion score change of ≤ 0.5 [At week 16]

42. Proportion of participants meeting achievement of PsA-modified SvdH erosion score change of ≤ SDC [At week 16]

43. Proportion of participants meeting achievement of PsA-modified SvdH joint space narrowing (JSN) score change of ≤ 0 [At week 16]

44. Proportion of participants meeting achievement of PsA-modified SvdH JSN score change of ≤ 0.5 [At week 16]

45. Proportion of participants meeting achievement of PsA-modified SvdH JSN score change of ≤ SDC [At week 16]

46. Change in PsA-modified SvdH erosion score from baseline [At week 16]

47. Change in PsA-modified SvdH JSN score [At week 16]

48. Change from baseline in domain scales scores of SF-36 [Up to 16 weeks]

49. Change from baseline in PCS score of SF-36 [Up to 16 weeks]

50. Change from baseline in MCS score of SF-36 [Up to 16 weeks]

51. Change from baseline in the subcomponents of the Work Productivity and Activity Impairment (WPAI) questionnaire [Up to 16 weeks]

52. Change from baseline in the 5-level EuroQoL 5-dimension (EQ-5D) utility scores [Up to 16 weeks]

53. Change from baseline in the 5-level EQ-5D-5L utility score subcomponents [Up to 16 weeks]

54. Change from baseline in Patient-Reported Outcome Measures Information System (PROMIS) sleep disturbance score (short form) [Up to 16 weeks]

55. Incidence of adverse events (AEs) [Up to 156 weeks]

56. Incidence of serious adverse events (SAEs) [Up to 156 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosed to have psoriatic arthritis (PsA) of at least 3 months duration at screening

• Meets the Classification Criteria for Psoriatic Arthritis at Screening

• Active plaque psoriatic skin lesion(s) or documented medical history of plaque psoriasis (PsO) at screening

• Active arthritis as shown by ≥ 3 swollen joints and ≥ 3 tender joints at Screening and day 1

• Participant has high sensitivity C-reactive protein (hsCRP) ≥ 3 mg/L at Screening

• ≥ 1 PsA-related hand and/or foot joint erosion on X-ray during Screening Period that is confirmed by central reading

• Must have completed the week 52 treatment for the optional open-label long-term extension period

Exclusion Criteria:

• Nonplaque psoriasis at screening or day 1

• Other autoimmune condition such as systemic lupus erythematous, mixed connective tissue disease, multiple sclerosis, or vasculitis

• History of or current inflammatory joint disease other than PsA (e.g., gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease)

• Active fibromyalgia

• Received an approved or investigational biologic therapy for the treatment of PsA or PsO

Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arthritis and Rheumatism Associates (ARA) - Jonesboro	Jonesboro	Arkansas	United States	72401
2	Local Institution	Fountain Valley	California	United States	92708
3	Local Institution	Los Angeles	California	United States	90045
4	Local Institution	Palm Desert	California	United States	92260
5	Integrative Skin Science and Research	Sacramento	California	United States	95815
6	Denver Arthritis Clinic - Lowry	Denver	Colorado	United States	80230
7	San Marcus Research Clinic, Inc.	Miami Lakes	Florida	United States	33014
8	Arthritis Center of North Georgia	Gainesville	Georgia	United States	30501
9	St. Luke's Intermountain Research Center-St. Luke's Clinic - Rheumatology	Boise	Idaho	United States	83702
10	Great Lakes Clinical Trials - West Wilson Avenue	Chicago	Illinois	United States	60640
11	Arthritis Center of Lexington-Bluegrass Community Research, Inc.	Lexington	Kentucky	United States	40504
12	Klein & Associates, M.D., P.A.	Hagerstown	Maryland	United States	21740
13	Local Institution	Toms River	New Jersey	United States	08755
14	Arthritis, Rheumatic & Bone Disease Associates, Affiliate of Trabecular Medical Group, LLC	Voorhees	New Jersey	United States	08043
15	University Hospitals Cleveland Medical Center-Dermatology	Cleveland	Ohio	United States	44106
16	Paramount Medical Research & Consulting, Llc	Middleburg Heights	Ohio	United States	44130
17	Clinical Research Source, Inc	Perrysburg	Ohio	United States	43551
18	Good Samaritan Hospital Corvallis	Corvallis	Oregon	United States	97330
19	Piedmont Arthritis Clinic	Greenville	South Carolina	United States	29601
20	West Tennessee Research Institute	Jackson	Tennessee	United States	38305
21	Arthritis & Rheumatology Research Institute	Allen	Texas	United States	75013
22	Amarillo Center for Clinical Research-Research	Amarillo	Texas	United States	79124
23	Metroplex Clinical Research Center	Dallas	Texas	United States	75231
24	Hospital Cordoba	Córdoba	Cordoba	Argentina	X5004CDT
25	Clinica Adventista Belgrano-Clinical Research	Buenos Aires	Distrito Federal	Argentina	C1430EGF
26	Local Institution	DQG	Distrito Federal	Argentina	C1428
27	Instituto de Reumatología	Capital	Mendoza	Argentina	5500
28	Centro Medico Privado de Reumatologia	San Miguel De Tucuman	Tucuman	Argentina	4000
29	Local Institution - 0048	Buenos Aires		Argentina	1194
30	Consultorios Reumatológicos Pampa	Buenos Aires		Argentina	1428
31	Local Institution	Cordoba		Argentina
32	Local Institution - 0137	Botany	New South Wales	Australia	2019
33	Local Institution - 0133	Westmead	New South Wales	Australia	2145
34	Local Institution - 0132	Woolloongabba	Queensland	Australia	4102
35	Local Institution - 0211	Hobart	Tasmania	Australia	7000
36	Local Institution - 0136	Camberwell	Victoria	Australia	3142
37	Local Institution	Clayton	Victoria	Australia	3168
38	Local Institution	Salvador	Bahia	Brazil	40150-150
39	Local Institution	Vitoria	Espirito Santo	Brazil	29055450
40	Local Institution	Juiz de Fora	Minas Gerais	Brazil	36010-570
41	Local Institution	Porto Alegre	RIO Grande DO SUL	Brazil	90610000
42	Local Institution	Sao Paulo		Brazil	09060 - 870
43	Local Institution - 0099	Santiago	Metropolitana	Chile	7500571
44	Local Institution - 0073	Santiago	Metropolitana	Chile	7501126
45	Local Institution - 0111	Santiago	Metropolitana	Chile	7640881
46	Local Institution - 0149	Hefei	Anhui	China	230071
47	Local Institution - 0159	Beijing	Beijing	China	100005
48	Local Institution - 0190	Chongqing	Chongqing	China	400010
49	Local Institution	Guangzhou	Guangdong	China	510120
50	Local Institution - 0143	Shenzhen	Guangdong	China	518020
51	Local Institution - 0150	DaLian	Liaoning	China	116000
52	Local Institution - 0146	Shanghai	Shanghai	China	200040
53	Local Institution	Yiwu	Zhejiang	China	322000
54	Local Institution - 0072	Barranquilla		Colombia	080020
55	Local Institution	Bogota		Colombia	111156
56	Local Institution - 0069	Bogotá		Colombia	110221
57	Local Institution	Bucaramanga		Colombia	680003
58	Local Institution	Cali		Colombia	760042
59	Local Institution	Medellín		Colombia	050034
60	Local Institution - 0065	Zipaquira		Colombia	250252
61	Local Institution - 0018	Ostrava		Czechia	722 00
62	Local Institution	Pardubice		Czechia	530 02
63	Local Institution - 0017	Prague		Czechia	13000
64	Local Institution - 0097	Praha 2		Czechia	12850
65	Local Institution - 0013	Helsinki		Finland	00290
66	Local Institution - 0089	Kuopio		Finland	70100
67	Local Institution	Turku		Finland	FI-20521 Turku
68	CHRU Troussau-Rhumatologie	Chambray les Tours		France	37170
69	CHU Montpellier Lapeyronie Hospital-Rhumatologie	Montpellier		France	34295
70	Assistance Publique Hôpitaux de Paris - Groupe Hospitalier 10e - Hôpital Lariboisière-RHEUMATOLOG	Paris		France	75010
71	Local Institution - 0049	Székesfehérvár	Fejér	Hungary	8000
72	Local Institution - 0023	Budapest		Hungary	1027
73	Local Institution	Budapest		Hungary	1027
74	Local Institution - 0026	Budapest		Hungary	1033
75	Local Institution - 0025	Budapest		Hungary	1036
76	Local Institution - 0068	Zalaegerszeg		Hungary	8900
77	Local Institution - 0104	Manorhamilton	Leitrim	Ireland	0
78	Local Institution - 0101	Dublin		Ireland	4
79	Local Institution	Dublin		Ireland
80	Local Institution	Galway		Ireland
81	Local Institution - 0066	Genova		Italy	16132
82	Local Institution - 0062	Pavia		Italy	27100
83	Local Institution	Udine		Italy	33100
84	Local Institution - 0058	Verona		Italy	37134
85	Local Institution - 0056	Saltillo	Coahuila	Mexico	25020
86	Local Institution	Ciudad de México	Distrito Federal	Mexico	06700
87	Local Institution - 0209	Mexico City	Distrito Federal	Mexico	14080
88	Local Institution - 0128	San Luis Potosí	SAN LUIS Potosi	Mexico	78200
89	Local Institution - 0061	Mérida	Yucatan	Mexico	97070
90	Local Institution - 0060	Chihuahua		Mexico	31000
91	Local Institution - 0095	Veracruz		Mexico	91900
92	Local Institution - 0114	Bialystok		Poland	15-351
93	Local Institution - 0140	Krakow		Poland	31-501
94	Local Institution - 0126	Kraków		Poland	30-002
95	Local Institution - 0162	Olsztyn		Poland	10-117
96	Local Institution - 0113	Poznan		Poland	60-218
97	Local Institution - 0112	Poznan		Poland	60-773
98	Local Institution - 0125	Warszawa		Poland	03-291
99	Local Institution	Brasov		Romania	500283
100	Local Institution	Bucharest		Romania	011025
101	Local Institution	Bucharest		Romania	011172
102	Local Institution	Bucuresti		Romania	011135
103	Local Institution	Cluj Napoca		Romania	400006
104	Local Institution	Râmnicu Vâlcea		Romania	240762
105	Local Institution	Timisoara		Romania	307220
106	Local Institution	Chelyabinsk		Russian Federation	454048
107	Local Institution	Kazan		Russian Federation	420101
108	Local Institution	Kemerovo		Russian Federation	650070
109	Local Institution	Korolev		Russian Federation	141060
110	Local Institution	Korolev		Russian Federation	141060
111	Local Institution	Moscow		Russian Federation	115522
112	Local Institution	Novosibirsk		Russian Federation	630005
113	Local Institution	Ryazan		Russian Federation	390026
114	Local Institution	Saint Petersburg		Russian Federation	194214
115	Local Institution	Saratov		Russian Federation	410053
116	Local Institution	Yaroslavl		Russian Federation	150003
117	Local Institution - 0021	A Coruña		Spain	15006
118	Local Institution - 0022	Cordoba		Spain	14004
119	Local Institution - 0019	Madrid		Spain	28046
120	Local Institution - 0020	Sabadell		Spain	08208
121	Local Institution - 0123	Kaohsiung City		Taiwan	833401
122	Local Institution	Tainan		Taiwan	704
123	Local Institution - 0122	Tainan		Taiwan	710
124	Local Institution	Taipei City		Taiwan	110
125	Local Institution - 0124	Taoyuan		Taiwan	333423
126	Local Institution	Harlow		United Kingdom	CM227NR
127	Local Institution - 0106	Southampton		United Kingdom	SO16 6YD
128	Local Institution	Stoke on Trent		United Kingdom	ST5 2GS

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls
• Investigator Inquiry Form

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT04908202
• Other Study ID Numbers: IM011-054; 2020-005097-10; U1111-1259-9443
• First Posted: Jun 1, 2021
• Last Update Posted: Aug 15, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Bristol-Myers Squibb: Biologic-Naive; BMS-986165; Deucravacitinib; Disease-modifying Anti-rheumatic Drugs; DMARDs; Joint Disease; Psoriatic Arthritis; PsA
• Additional relevant MeSH terms: Arthritis; Arthritis, Psoriatic; Rheumatic Diseases; BMS-986165

Study Results

No Results Posted as of Aug 15, 2022