Efficacy and Safety of Tildrakizumab Compared to Placebo in Subjects With Active Psoriatic Arthritis I (INSPIRE 1)

• Sponsor: Sun Pharmaceutical Industries Limited (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04314544
• Collaborator: (none)
• Enrollment: 472
• Locations: 96
• Arms: 2
• Anticipated Duration (Months): 35
• Patients Per Site: 4.9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This is a multicenter Phase III, Randomized, Double-Blind, Single-Dose, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of tildrakizumab in Subjects with Active Psoriatic Arthritis I (INSPIRE 1)

Condition or Disease	Intervention/Treatment	Phase
Active Psoriatic Arthritis	Drug: TILD; Drug: matching placebo injections	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 472 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase III, Randomized, Double-Blind, Single-Dose, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of Tildrakizumab in Subjects With Active Psoriatic Arthritis I (INSPIRE 1)
• Actual Study Start Date: Jul 1, 2020
• Anticipated Primary Completion Date: Mar 31, 2023
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A	Drug: TILD; one 1 mL injection of study medication
Placebo Comparator: Arm B	Drug: matching placebo injections; one 1 mL injection of placebo

Outcome Measures

Primary Outcome Measures

1. The proportion of subjects who achieve American College of Rheumatology [ACR20] [at week 24]

   the proportion of subjects achieving a 20% reduction from Baseline in response criteria

Secondary Outcome Measures

1. The proportion of subjects achieving American College of Rheumatology [ACR50] [at Week 24]

   the proportion of subjects achieving a 50% reduction from Baseline in response criteria

2. The proportion of subjects achieving American College of Rheumatology [ACR70] [at Week 24]

   the proportion of subjects achieving a 70% reduction from Baseline in response criteria

3. The proportion of subjects achieving Psoriasis Area and Severity Index 75 response among subjects with Body surface area ≥3% at baseline [at Weeks 24]

4. The change from Baseline in the van der Heijde modified total Sharp score [at Week 24]

5. The change from Baseline in the van der Heijde modified total Sharp score [at Week 16]

6. Change from Baseline in American College of Rheumatology Response Criteria Components Score [at Week 24]

   Tender Joint Count (68), Swollen Joint Count (66), Physician's Global Assessment of Arthritis (Visual Analog Scale, 0-100), Patient's Global Assessment of Arthritis (Visual Analog Scale, 0-100), Patient's Assessment of Arthritis Pain (Visual Analog Scale, 0-100), C-reactive protein levels, Erythrocyte sedimentation rate levels

7. change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index [at Week 24]

8. change from Baseline in Leeds Enthesitis Index [at Week 24]

9. The change from Baseline in Leeds Dactylitis Index [at Week 24]

10. The proportion of subjects who achieve a disease activity score-C-reactive protein < 3.2 [at Week 24]

11. The change from Baseline in van der Heijde modified Sharp sub-scores (erosion score and joint space narrowing score) [at Week 24]

12. The proportion of subjects with the Change in van der Heijde modified total Sharp score <0 and < 0.5 [at Week 24.]

13. The proportion of subjects with active Psoriasis and Body surface area ≥3% [at Week 24]

    with: Psoriasis Area and Severity Index 90 and Psoriasis Area and Severity Index 100

14. The change from Baseline in subjects with active Psoriasis and Body surface area ≥ 3% ("those with involvement of nails" ) [at Week 24]

    Physician Global Assessment-Psoriasis and nail psoriasis severity index

15. The proportion of subjects achieving American College of Rheumatology [ACR20, ACR50 and ACR70] [at week 52]

    the proportion of subjects achieving a 20/50/70% reduction from Baseline in response criteria

16. The change from Baseline in American College of Rheumatology Response Criteria Components Score [at Week 52]

    Tender Joint Count (68), Swollen Joint Count (66), Physician's Global Assessment of Arthritis (Visual Analog Scale, 0-100), Patient's Global Assessment of Arthritis (Visual Analog Scale, 0-100), Patient's Assessment of Arthritis Pain (Visual Analog Scale, 0-100), C-reactive protein levels, Erythrocyte sedimentation rate levels

17. The change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index [at Week 52]

18. The change from Baseline [at Week 52]

    Leeds Enthesitis Index, Leeds Dactylitis Index, Health Assessment Questionnaire Disability Index Score

19. The proportion of subjects who achieve a Disease Activity Score(28 [joints]-C-reactive protein) < 3.2 [at Week 52]

20. The change from Baseline in van der Heijde modified total Sharp score [at Week 52]

21. The change from Baseline in van der Heijde modified Sharp sub-scores (erosion score and joint space narrowing score) [at Week 52]

22. The proportion of subjects with the change in van der Heijde modified total Sharp score <0 and < 0.5 [at Week 52]

23. In subjects with active Psoriasis and Body surface area ≥3%, the proportion of subjects [at Week 52]

    Psoriasis Area and Severity Index 75, Psoriasis Area and Severity Index 90 and Psoriasis Area and Severity Index 100

24. In subjects with active Psoriasis and Body surface area ≥3% those with involvement of nails , the change from Baseline in nail psoriasis severity index [at Week 52]

25. In subjects with active Psoriasis and Body surface area ≥3%, the change from Baseline in Physician Global Assessment-Psoriasis [at Week 52]

26. Change from baseline in health assessment questionnaire - disability index (HAQ-DI) score [at Week 24]

27. The change from Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components [Weeks 24 and 52]

    Physical Functioning Domain, Role-Physical Domain, Role-Emotional Domain, Bodily Pain Domain, Mental Health Domain, General Health Domain, Vitality Domain, Social Functioning Domain, Physical Component Summary Score, Mental Component Summary Score

28. The change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scores [at Week 24]

Other Outcome Measures

1. The proportion of subjects achieving American College of Rheumatology [ACR20] [Weeks 24 and 52]

   the proportion of subjects achieving a 20% reduction from Baseline in response criteria

2. The proportion of subjects achieving American College of Rheumatology [ACR50] [Weeks 24 and 52]

   the proportion of subjects achieving a 50% reduction from Baseline in response criteria

3. The proportion of subjects achieving American College of Rheumatology [ACR70] [Weeks 24 and 52]

   the proportion of subjects achieving a 70% reduction from Baseline in response criteria

4. The change from Baseline in American College of Rheumatology Response Criteria Components Score [Weeks 24 and 52]

   Tender Joint Count (68), Swollen Joint Count (66), Physician's Global Assessment of Arthritis (Visual Analog Scale, 0-100), Patient's Global Assessment of Arthritis (Visual Analog Scale, 0-100), Patient's Assessment of Arthritis Pain (Visual Analog Scale, 0-100), C-reactive protein levels and Erythrocyte sedimentation rate levels

5. The change from Baseline [Weeks 24 and 52]

   Leeds Enthesitis Index, Leeds Dactylitis Index, Bath Ankylosing Spondylitis Disease Activity Index and Health Assessment Questionnaire Disability Index score

6. The proportion of subjects who achieve a Disease activity score-C-reactive protein < 3.2 [Weeks 24 and 52]

7. The proportion of subjects with active Psoriasis and Body surface area ≥ 3% [Weeks 24 and 52]

   Psoriasis Area and Severity Index 75, Psoriasis Area and Severity Index 90 and Psoriasis Area and Severity Index 100

8. The change from Baseline in the levels of "Metabolic Biomarkers" [at Week 24]

9. the change from baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) [at Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 52]

10. proportion of subjects who achieve a response based on Modified Psoriatic Arthritis Responder Criteria (PsARC) [at Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 52.]

11. change from baseline in Work Productivity and Activity Impairment Questionnaire Scores [at Week 12,16 24, 48 and 52]

12. change from baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) [at Week 8,16, 24 and 52.]

Eligibility Criteria

Criteria

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

Inclusion Criteria:

1. Subject has provided written informed consent.

2. Subject is ≥ 18 years of age at time of Screening.

3. RF and anti-CCP Ab negative.

4. Subjects must have prior exposure to anti-TNF agent(s) use for the treatment of PsO or PsA.

Exclusion Criteria:

1. Subject has a planned surgical intervention between Baseline and the Week 24 evaluation for a pretreatment condition.

2. Subject has an active infection or history of infections as follows:

• any active infection for which systemic anti-infectives were used within 28 days prior to first IMP dose, with the last dose having been received within 7 days of Screening,

• a serious infection, defined as requiring hospitalization or IV anti-infectives within 8 weeks prior to the first IMP dose, with the last dose having been received within 7 days of Screening,

• recurrent or chronic infections, e.g., chronic pyelonephritis, chronic osteomyelitis, bronchiectasis, or other active infection that, in the opinion of the Investigator, might cause this study to be detrimental to the subject.

1. Subject has a known history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.

2. Subject had myocardial infarction, unstable angina pectoris, or ischemic stroke within the past 6 months prior to the first IMP dose.

3. Subject has any active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma.

4. Subject has a history of malignancy within 5 years from the time of Screening EXCEPT treated and considered cured cutaneous basal or squamous cell carcinoma, in situ cervical carcinoma, OR in situ breast ductal carcinoma.

5. Subjects with a history of alcohol or drug abuse in the previous 2 years.

6. Female subjects of childbearing potential who do not agree to abstain from heterosexual activity or practice a dual method of contraception, for example, a combination of the following: (1) oral contraceptive, depo progesterone, or intrauterine device; and (2) a barrier method (condom or diaphragm). Male subjects with female partners of childbearing potential who are not using birth control as described above must use a barrier method of contraception (e.g., condom) if not surgically sterile (i.e., vasectomy). Contraceptive methods must be practiced upon entering the study and through 17 weeks after the last dose of IMP. If a subject discontinues prematurely, the contraceptive method must be practiced for 17 weeks following final administration of IMP. A FSH test should be performed to confirm menopause for those women with no menses for less than 1 year.

7. Subject currently enrolled in another investigational device/procedure or drug study, or Baseline of this study is less than 30 days or 5 half-lives (whichever is longer) since ending another investigational device/procedure or drug study(s), or receiving other investigational agent(s).

8. Subject previously has been enrolled (randomized) in this study.

9. Subject has any kind of disorder that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures.

10. Donation or loss of 400 mL or more of blood within 8 weeks before dosing.

11. Subjects who have been placed in an institution on official or judicial orders.

12. Subjects who are related to or dependent on the Investigator, Sponsor, or study site such that a conflict of interest could arise.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sunpharma Site no 47	Anniston	Alabama	United States	36207
2	Sunpharma Site no 42	Dothan	Alabama	United States	36305
3	Sunpharma Site no 29	Gilbert	Arizona	United States	85297
4	Sunpharma Site no 31	Mesa	Arizona	United States	85210
5	Sunpharma Site no 30	Phoenix	Arizona	United States	85032
6	Sunpharma Site no 43	Scottsdale	Arizona	United States	85258
7	Sunpharma Site no 35	Covina	California	United States	91722
8	Sunpharma Site no 48	Encino	California	United States	91436
9	Sunpharma site no. 17	Fountain Valley	California	United States	92708
10	Sunpharma site no. 15	Thousand Oaks	California	United States	91320
11	Sunpharma Site no 40	Denver	Colorado	United States	80230
12	Sunpharma Site no 36	Fort Collins	Colorado	United States	80528
13	Sunpharma Site no 32	Bridgeport	Connecticut	United States	06606
14	Sunpharma site no. 21	Clearwater	Florida	United States	33765
15	Sunpharma site no. 02	Hialeah	Florida	United States	33016
16	Sunpharma Site no 39	Hollywood	Florida	United States	33024
17	Sunpharma Site no 55	Kissimmee	Florida	United States	34741
18	Sunpharma Site no. 75	Margate	Florida	United States	33063
19	Sunpharma site no. 19	Miami	Florida	United States	33135
20	Sunpharma site no. 05	New Port Richey	Florida	United States	34652
21	Sunpharma Site no. 76	Ocoee	Florida	United States	34761
22	SunPharma Site no 22	Tamarac	Florida	United States	33321
23	Sunpharma Site no 46	Gainesville	Georgia	United States	30501
24	Sunpharma Site no 41	Oak Brook	Illinois	United States	60523
25	Sunpharma Site no 54	Orland Park	Illinois	United States	60467
26	Sunpharma Site no 38	Schaumburg	Illinois	United States	60185
27	Sunpharma Site no 37	Skokie	Illinois	United States	60076
28	Sunpharma site no. 20	Wichita	Kansas	United States	67207
29	Sunpharma Site no 26	Lake Charles	Louisiana	United States	70605
30	Sunpharma site no. 07	Worcester	Massachusetts	United States	01605
31	Sunpharma site no. 10	Lansing	Michigan	United States	48910
32	Sunpharma Site no 45	Eagan	Minnesota	United States	55121
33	Sunpharma site no. 14	Springfield	Missouri	United States	65810
34	Sunpharma Site no 53	Kalispell	Montana	United States	59901
35	Sunpharma Site no 27	Lincoln	Nebraska	United States	68516
36	Sunpharma Site no 44	Voorhees	New Jersey	United States	08043
37	Sunpharma site no. 09	Rochester	New York	United States	14623
38	Sunpharma Site no 52	Charlotte	North Carolina	United States	28204
39	Sunpharma Site no. 73	Leland	North Carolina	United States	28451
40	Sunpharma Site no 56	Wilmington	North Carolina	United States	28401
41	Sunpharma Site no 33	Minot	North Dakota	United States	58701
42	Sunpharma site no. 18	Cincinnati	Ohio	United States	45242
43	Sunpharma site no. 11	Middleburg Heights	Ohio	United States	44130
44	Sunpharma site no. 25	Wyomissing	Pennsylvania	United States	19610
45	Sunpharma Site no 34	Greenville	South Carolina	United States	29601
46	Sunpharma Site no 50	Austin	Texas	United States	78745
47	Sunpharma site no. 13	Baytown	Texas	United States	77521
48	Sunpharma Site no 49	Grapevine	Texas	United States	76051
49	Sunpharma site no. 06	Houston	Texas	United States	77004
50	Sunpharma site no. 08	Houston	Texas	United States	77084
51	Sunpharma site no. 04	League City	Texas	United States	77573
52	Sunpharma Site no 28	Lubbock	Texas	United States	79410
53	Sunpharma Site no. 74	Mesquite	Texas	United States	75150
54	Sunpharma site no. 03	San Antonio	Texas	United States	78229
55	Sunpharma site no. 16	San Antonio	Texas	United States	78229
56	Sunpharma site no. 01	Tomball	Texas	United States	77375
57	Sunpharma site no. 12	Spokane	Washington	United States	99204
58	Sunpharma Site no. 81	Phillip	Australian Capital Territory	Australia	2606
59	Sunpharma Site no. 84	Kogarah	New South Wales	Australia	2217
60	Sunpharma Site no 68	Maroochydore	Queensland	Australia	4558
61	Sunpharma site no. 24	Hobart	Tasmania	Australia	7000
62	Sunpharma Site no 67	Camberwell	Victoria	Australia	3145
63	Sunpharma Site no. 82	Fitzroy	Victoria	Australia	3065
64	Sunpharma Site no. 83	Murdoch	Western Australia	Australia	6150
65	Sunpharma Site no. 96	Zlín		Czechia	760 01
66	Sunpharma Site no. 85	Tallinn		Estonia	10117
67	Sunpharma Site no. 87	Tartu		Estonia	50106
68	Sunpharma Site no. 86	Tartu		Estonia	50708
69	Sunpharma Site no. 89	Bad Doberan		Germany	18209
70	Sunpharma Site no. 91	Berlin		Germany	12161
71	Sunpharma Site no. 90	Berlin		Germany	13125
72	Sunpharma Site no 69	Incheon		Korea, Republic of	22332
73	Sunpharma Site no 72	Seoul		Korea, Republic of	16499
74	Sunpharma Site no 71	Seoul		Korea, Republic of	3080
75	Sunpharma Site no 70	Seoul		Korea, Republic of	4763
76	Sunpharma Site no. 95	Warsaw	Mazowiecki	Poland	05-830
77	Sunpharma Site no. 93	Bialystok		Poland	15-879
78	Sunpharma Site no. 94	Krakow		Poland	30-033
79	Sunpharma Site no. 92	Poznan		Poland	61-113
80	Sunpharma Site no. 88	Martin		Slovakia	3601
81	Sunpharma Site no 57	Cordoba		Spain	14004
82	SunPharma Site No 23	Córdoba		Spain	14004
83	Sunpharma Site no 58	La Coruña		Spain	15006
84	Sunpharma Site no. 78	Madrid		Spain	28046
85	Sunpharma Site no. 77	Sevilla		Spain	41013
86	Sunpharma Site no 59	Valencia		Spain	46010
87	Sunpharma Site no 51	Valencia		Spain	46026
88	Sunpharma Site no 65	Taipei	Pai-Tou	Taiwan	112
89	Sunpharma Site no 63	Jianguo	Taichung	Taiwan	402
90	Sunpharma Site no. 79	Hsinchu		Taiwan	300
91	Sunpharma Site no. 80	Kaohsiung		Taiwan	80756
92	Sunpharma Site no 62	Kaohsiung		Taiwan	833
93	Sunpharma Site no 61	Taichung		Taiwan	704
94	Sunpharma Site no 60	Tainan		Taiwan	710
95	Sunpharma Site no 64	Taipei		Taiwan	112
96	Sunpharma Site no 66	Taipei		Taiwan	114

Sponsors and Collaborators

• Sun Pharmaceutical Industries Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sun Pharmaceutical Industries Limited
• ClinicalTrials.gov Identifier: NCT04314544
• Other Study ID Numbers: TILD-19-07
• First Posted: Mar 19, 2020
• Last Update Posted: Aug 9, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Arthritis; Arthritis, Psoriatic

Study Results

No Results Posted as of Aug 9, 2022