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

Active Psoriatic Arthritis Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04314544
• Other study ID #: TILD-19-07
• Status: Recruiting
• Phase: Phase 3
• Start date: July 1, 2020
• Est. completion date: March 2025

Study information

• Verified date: February 2024
• Source: Sun Pharmaceutical Industries Limited
• Contact: Head, Clinical development
• Phone: 91 2266455645
• Email: Clinical.Trial[@]sunpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 472
• Est. completion date: March 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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

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

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

6. 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.

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

8. 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.

9. 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).

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

11. 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.

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

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

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

Related Conditions & MeSH terms

• Active Psoriatic Arthritis
• Arthritis
• Arthritis, Psoriatic

Intervention

Drug:
• TILD
one 1 mL injection of study medication
• matching placebo injections
one 1 mL injection of placebo

Locations

Country	Name	City	State
Australia	Sunpharma Site no 67	Camberwell	Victoria
Australia	Sunpharma Site no. 82	Fitzroy	Victoria
Australia	Sunpharma site no. 24	Hobart	Tasmania
Australia	Sunpharma Site no. 84	Kogarah	New South Wales
Australia	Sunpharma Site no 68	Maroochydore	Queensland
Australia	Sunpharma Site no. 83	Murdoch	Western Australia
Australia	Sunpharma Site no. 81	Phillip	Australian Capital Territory
Canada	Sunpharma Site no. 97	Markham	Ontario
Canada	Sunpharma site 98	Trois-Rivières	Quebec
Czechia	Sun pharma site 99	Brno
Czechia	Sunpharma Site no. 100	Prague 2
Czechia	Sunpharma Site no. 101	Praha 4
Czechia	Sunpharma Site no. 96	Zlín
Estonia	Sunpharma site no. 102	Tallin
Estonia	Sunpharma Site no. 85	Tallinn
Estonia	Sunpharma Site no. 86	Tartu
Estonia	Sunpharma Site no. 87	Tartu
Germany	Sunpharma Site no. 89	Bad Doberan
Germany	Sunpharma Site no. 90	Berlin
Germany	Sunpharma Site no. 91	Berlin
Germany	Sunpharma Site no. 103	Herne
India	Sunpharma Site no. 127	Bangalore	Karnataka
India	Sunpharma Site no. 130	Belgaum	Karnataka
India	Sunpharma Site no. 132	Hubli	Karnataka
India	Sunpharma Site no. 133	Hyderabad	Telangana
India	Sunpharma Site no. 135	Hyderabad	Telangana
India	Sunpharma Site no. 129	Lucknow	Uttar Pradesh
India	Sunpharma Site no. 128	Mylapore	Chennai
India	Sunpharma Site no. 131	Pune	Maharashtra
India	Sunpharma Site no. 134	Surat	Gujarat
Italy	Sunpharma Site no. 120	Brescia
Italy	Sunpharma Site no. 104	Milan
Italy	Sunpharma Site no. 138	Verona
Korea, Republic of	Sunpharma Site no. 126	Daejeon
Korea, Republic of	Sunpharma Site no 72	Gyeonggi-do
Korea, Republic of	Sunpharma Site no 69	Incheon
Korea, Republic of	Sunpharma Site no 70	Seoul
Korea, Republic of	Sunpharma Site no 71	Seoul
Poland	Sunpharma Site no. 110	Bialystok
Poland	Sunpharma Site no. 93	Bialystok
Poland	Sunpharma Site no. 139	Katowice
Poland	Sunpharma Site no. 109	Krakow
Poland	Sunpharma Site no. 94	Krakow
Poland	Sunpharma Site no. 107	Lublin
Poland	Sunpharma Site no. 136	Olsztyn
Poland	Sunpharma Site no. 106	Ponzan
Poland	Sunpharma Site no. 92	Poznan
Poland	Sunpharma Site no. 108	Torun
Poland	Sunpharma Site no. 95	Warsaw	Mazowiecki
Poland	Sunpharma Site no. 111	Warszawa
Poland	Sunpharma Site no. 137	Wroclaw
Slovakia	Sunpharma Site no. 88	Martin
Slovakia	Sunpharma Site no. 113	Rimavska Sobota
Slovakia	Sunpharma Site no. 114	Svidnik
Slovakia	Sunpharma Site no. 112	Vahom
Spain	SunPharma Site No 23	Córdoba
Spain	Sunpharma Site no. 118	Gran Canaria
Spain	Sunpharma Site no 58	La Coruña
Spain	Sunpharma Site no. 78	Madrid
Spain	Sunpharma Site no. 116	Malaga
Spain	Sunpharma Site no. 125	Sabadell
Spain	Sunpharma Site no. 115	Santiago de Compostela
Spain	Sunpharma Site no. 117	Sevilla
Spain	Sunpharma Site no. 77	Sevilla
Spain	Sunpharma Site no 51	Valencia
Spain	Sunpharma Site no 59	Valencia
Taiwan	Sunpharma Site no. 79	Hsinchu
Taiwan	Sunpharma Site no 63	Jianguo	Taichung
Taiwan	Sunpharma Site no 62	Kaohsiung
Taiwan	Sunpharma Site no. 80	Kaohsiung
Taiwan	Sunpharma Site no 61	Taichung
Taiwan	Sunpharma Site no 60	Tainan
Taiwan	Sunpharma Site no 64	Taipei
Taiwan	Sunpharma Site no 65	Taipei	Pai-Tou
Taiwan	Sunpharma Site no 66	Taipei
United States	Sunpharma Site no 47	Anniston	Alabama
United States	Sunpharma Site no 50	Austin	Texas
United States	Sunpharma site no. 13	Baytown	Texas
United States	Sunpharma Site no 32	Bridgeport	Connecticut
United States	Sunpharma Site no 52	Charlotte	North Carolina
United States	Sunpharma site no. 18	Cincinnati	Ohio
United States	Sunpharma site no. 21	Clearwater	Florida
United States	Sunpharma Site no 49	Colleyville	Texas
United States	Sunpharma Site no 35	Covina	California
United States	Sunpharma Site no 40	Denver	Colorado
United States	Sunpharma Site no 42	Dothan	Alabama
United States	Sunpharma Site no 45	Eagan	Minnesota
United States	Sunpharma Site no 48	Encino	California
United States	Sunpharma Site no 36	Fort Collins	Colorado
United States	Sunpharma site no. 17	Fountain Valley	California
United States	Sunpharma Site no 46	Gainesville	Georgia
United States	Sunpharma Site no 29	Gilbert	Arizona
United States	Sunpharma Site no 30	Glendale	Arizona
United States	Sunpharma Site no 34	Greenville	South Carolina
United States	Sunpharma site no. 02	Hialeah	Florida
United States	Sunpharma Site no 39	Hollywood	Florida
United States	Sunpharma site no. 06	Houston	Texas
United States	Sunpharma site no. 08	Houston	Texas
United States	Sunpharma Site no 53	Kalispell	Montana
United States	Sunpharma Site no 55	Kissimmee	Florida
United States	Sunpharma site no. 10	Lansing	Michigan
United States	Sunpharma site no. 04	League City	Texas
United States	Sunpharma Site no. 73	Leland	North Carolina
United States	Sunpharma Site no 27	Lincoln	Nebraska
United States	Sunpharma Site no 28	Lubbock	Texas
United States	Sunpharma Site no. 75	Margate	Florida
United States	Sunpharma Site no 31	Mesa	Arizona
United States	Sunpharma Site no. 74	Mesquite	Texas
United States	Sunpharma site no. 19	Miami	Florida
United States	Sunpharma site no. 11	Middleburg Heights	Ohio
United States	Sunpharma Site no 33	Minot	North Dakota
United States	Sunpharma site no. 05	New Port Richey	Florida
United States	Sunpharma Site no 41	Oak Brook	Illinois
United States	Sunpharma Site no. 76	Ocoee	Florida
United States	Sunpharma Site no. 124	Oklahoma City	Oklahoma
United States	Sunpharma Site no 54	Orland Park	Illinois
United States	Sunpharma site no. 09	Rochester	New York
United States	Sunpharma Site no. 123	Saint Louis	Missouri
United States	Sunpharma Site no. 121	Salt Lake City	Utah
United States	Sunpharma site no. 03	San Antonio	Texas
United States	Sunpharma site no. 16	San Antonio	Texas
United States	Sunpharma Site no 38	Schaumburg	Illinois
United States	Sunpharma Site no 43	Scottsdale	Arizona
United States	Sunpharma Site no 37	Skokie	Illinois
United States	Sunpharma Site no. 122	Skokie	Illinois
United States	Sunpharma site no. 12	Spokane	Washington
United States	Sunpharma site no. 14	Springfield	Missouri
United States	Sunpharma Site no 26	Stafford	Texas
United States	SunPharma Site no 22	Tamarac	Florida
United States	Sunpharma site no. 15	Thousand Oaks	California
United States	Sunpharma site no. 01	Tomball	Texas
United States	Sunpharma Site no 44	Voorhees	New Jersey
United States	Sunpharma site no. 20	Wichita	Kansas
United States	Sunpharma Site no 56	Wilmington	North Carolina
United States	Sunpharma site no. 07	Worcester	Massachusetts
United States	Sunpharma site no. 25	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Sun Pharmaceutical Industries Limited

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Czechia,  Estonia,  Germany,  India,  Italy,  Korea, Republic of,  Poland,  Slovakia,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The proportion of subjects achieving American College of Rheumatology [ACR20]	the proportion of subjects achieving a 20% reduction from Baseline in response criteria	Weeks 24 and 52
Other	The proportion of subjects achieving American College of Rheumatology [ACR50]	the proportion of subjects achieving a 50% reduction from Baseline in response criteria	Weeks 24 and 52
Other	The proportion of subjects achieving American College of Rheumatology [ACR70]	the proportion of subjects achieving a 70% reduction from Baseline in response criteria	Weeks 24 and 52
Other	The change from Baseline in American College of Rheumatology Response Criteria Components Score	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	Weeks 24 and 52
Other	The change from Baseline	Leeds Enthesitis Index, Leeds Dactylitis Index, Bath Ankylosing Spondylitis Disease Activity Index and Health Assessment Questionnaire Disability Index score	Weeks 24 and 52
Other	The proportion of subjects who achieve a Disease activity score-C-reactive protein < 3.2		Weeks 24 and 52
Other	The proportion of subjects with active Psoriasis and Body surface area = 3%	Psoriasis Area and Severity Index 75, Psoriasis Area and Severity Index 90 and Psoriasis Area and Severity Index 100	Weeks 24 and 52
Other	The change from Baseline in the levels of "Metabolic Biomarkers"		at Week 24
Other	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
Other	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.
Other	change from baseline in Work Productivity and Activity Impairment Questionnaire Scores		at Week 12,16 24, 48 and 52
Other	change from baseline in Psoriatic Arthritis Disease Activity Score (PASDAS)		at Week 8,16, 24 and 52.
Primary	The proportion of subjects who achieve American College of Rheumatology [ACR20]	the proportion of subjects achieving a 20% reduction from Baseline in response criteria	at week 24
Secondary	The proportion of subjects achieving American College of Rheumatology [ACR50]	the proportion of subjects achieving a 50% reduction from Baseline in response criteria	at Week 24
Secondary	The proportion of subjects achieving American College of Rheumatology [ACR70]	the proportion of subjects achieving a 70% reduction from Baseline in response criteria	at Week 24
Secondary	The proportion of subjects achieving Psoriasis Area and Severity Index 75 response among subjects with Body surface area =3% at baseline		at Weeks 24
Secondary	The change from Baseline in the van der Heijde modified total Sharp score		at Week 24
Secondary	The change from Baseline in the van der Heijde modified total Sharp score		at Week 16
Secondary	Change from Baseline in American College of Rheumatology Response Criteria Components Score	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	at Week 24
Secondary	change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index		at Week 24
Secondary	change from Baseline in Leeds Enthesitis Index		at Week 24
Secondary	The change from Baseline in Leeds Dactylitis Index		at Week 24
Secondary	The proportion of subjects who achieve a disease activity score-C-reactive protein < 3.2		at Week 24
Secondary	The change from Baseline in van der Heijde modified Sharp sub-scores (erosion score and joint space narrowing score)		at Week 24
Secondary	The proportion of subjects with the Change in van der Heijde modified total Sharp score <0 and < 0.5		at Week 24.
Secondary	The proportion of subjects with active Psoriasis and Body surface area =3%	with: Psoriasis Area and Severity Index 90 and Psoriasis Area and Severity Index 100	at Week 24
Secondary	The change from Baseline in subjects with active Psoriasis and Body surface area = 3% ("those with involvement of nails" )	Physician Global Assessment-Psoriasis and nail psoriasis severity index	at Week 24
Secondary	The proportion of subjects achieving American College of Rheumatology [ACR20, ACR50 and ACR70]	the proportion of subjects achieving a 20/50/70% reduction from Baseline in response criteria	at week 52
Secondary	The change from Baseline in American College of Rheumatology Response Criteria Components Score	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	at Week 52
Secondary	The change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index		at Week 52
Secondary	The change from Baseline	Leeds Enthesitis Index, Leeds Dactylitis Index, Health Assessment Questionnaire Disability Index Score	at Week 52
Secondary	The proportion of subjects who achieve a Disease Activity Score(28 [joints]-C-reactive protein) < 3.2		at Week 52
Secondary	The change from Baseline in van der Heijde modified total Sharp score		at Week 52
Secondary	The change from Baseline in van der Heijde modified Sharp sub-scores (erosion score and joint space narrowing score)		at Week 52
Secondary	The proportion of subjects with the change in van der Heijde modified total Sharp score <0 and < 0.5		at Week 52
Secondary	In subjects with active Psoriasis and Body surface area =3%, the proportion of subjects	Psoriasis Area and Severity Index 75, Psoriasis Area and Severity Index 90 and Psoriasis Area and Severity Index 100	at Week 52
Secondary	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
Secondary	In subjects with active Psoriasis and Body surface area =3%, the change from Baseline in Physician Global Assessment-Psoriasis		at Week 52
Secondary	Change from baseline in health assessment questionnaire - disability index (HAQ-DI) score		at Week 24
Secondary	The change from Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components	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	Weeks 24 and 52
Secondary	The change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scores		at Week 24