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

Phase 3

Active, not recruiting

• Conditions: Active Psoriatic Arthritis
• Interventions: Drug: TILD; Drug: matching placebo injections

• Registration Number: NCT04314544
• Lead Sponsor: Sun Pharmaceutical Industries Limited

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-13
• Study First Submitted QC: 2020-03-17
• Study First Posted: 2020-03-19
• Study Start: 2020-07-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-07
• Primary Completion: 2025-09
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 510

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	TILD	-
Arm B	matching placebo injections	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
The proportion of subjects achieving Psoriasis Area and Severity Index 75 response among subjects with Body surface area ≥3% at baseline	at Weeks 24
The change from Baseline in Leeds Dactylitis Index	at Week 24
The proportion of subjects who achieve a disease activity score-C-reactive protein < 3.2	at Week 24
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
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
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
Change from baseline in health assessment questionnaire - disability index (HAQ-DI) score	at Week 24
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
The change from Baseline in the van der Heijde modified total Sharp score	at Week 16
The change from Baseline in van der Heijde modified total Sharp score	at Week 52
The proportion of subjects with the change in van der Heijde modified total Sharp score <0 and < 0.5	at Week 52
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
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
change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index	at Week 24
The change from Baseline in van der Heijde modified Sharp sub-scores (erosion score and joint space narrowing score)	at Week 52
The proportion of subjects with the Change in van der Heijde modified total Sharp score <0 and < 0.5	at Week 24.
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
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
The change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index	at Week 52
The change from Baseline	at Week 52	Leeds Enthesitis Index, Leeds Dactylitis Index, Health Assessment Questionnaire Disability Index Score
change from Baseline in Leeds Enthesitis Index	at Week 24
In subjects with active Psoriasis and Body surface area ≥3%, the change from Baseline in Physician Global Assessment-Psoriasis	at Week 52
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
The proportion of subjects who achieve a Disease Activity Score(28 [joints]-C-reactive protein) < 3.2	at Week 52
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
The change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scores	at Week 24

Trial Locations

Locations (112)

Sunpharma site 98; 🇨🇦 Trois-Rivières, Quebec, Canada

Sunpharma Site no. 95; 🇵🇱 Warsaw, Mazowiecki, Poland

Sunpharma Site no. 93; 🇵🇱 Bialystok, Poland

Sunpharma Site no. 110; 🇵🇱 Białystok, Poland

Sunpharma Site no. 139; 🇵🇱 Katowice, 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. 111; 🇵🇱 Warszawa, Poland

Sunpharma Site no. 137; 🇵🇱 Wroclaw, Poland

Sunpharma Site no. 88; 🇸🇰 Martin, Slovakia

Sunpharma Site no. 113; 🇸🇰 Rimavska Sobota, Slovakia

Sunpharma Site no. 112; 🇸🇰 Vahom, Slovakia

SunPharma Site No 23; 🇪🇸 Córdoba, 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. 77; 🇪🇸 Sevilla, Spain

Sunpharma Site no. 117; 🇪🇸 Sevilla, Spain

Sunpharma Site no 59; 🇪🇸 Valencia, Spain

Sunpharma Site no 65; 🇨🇳 Taipei, Pai-Tou, Taiwan

Sunpharma Site no 63; 🇨🇳 Jianguo, Taichung, Taiwan

Sunpharma Site no. 79; 🇨🇳 Hsinchu, Taiwan

Sunpharma Site no. 80; 🇨🇳 Kaohsiung, Taiwan

Sunpharma Site no 62; 🇨🇳 Kaohsiung, Taiwan

Sunpharma Site no 60; 🇨🇳 Tainan, Taiwan

Sunpharma Site no 64; 🇨🇳 Taipei, Taiwan

Sunpharma Site no 37; 🇺🇸 Skokie, Illinois, United States

Sunpharma Site no. 122; 🇺🇸 Skokie, Illinois, United States

Sunpharma site no. 20; 🇺🇸 Wichita, Kansas, United States

Sunpharma site no. 24; 🇦🇺 Hobart, Tasmania, Australia

Sunpharma Site no. 82; 🇦🇺 Fitzroy, Victoria, Australia

Sunpharma Site no 38; 🇺🇸 Schaumburg, Illinois, United States

Sunpharma Site no 70; 🇰🇷 Seoul, Korea, Republic of

Sunpharma Site no 42; 🇺🇸 Dothan, Alabama, United States

Sunpharma Site no 29; 🇺🇸 Gilbert, Arizona, United States

Sunpharma Site no 30; 🇺🇸 Glendale, Arizona, United States

Sunpharma Site no 31; 🇺🇸 Mesa, Arizona, United States

Sunpharma Site no 35; 🇺🇸 Covina, California, United States

Sunpharma Site no 48; 🇺🇸 Encino, California, United States

Sunpharma site no. 17; 🇺🇸 Fountain Valley, California, United States

Sunpharma site no. 15; 🇺🇸 Thousand Oaks, California, United States

Sunpharma Site no 40; 🇺🇸 Denver, Colorado, United States

Sunpharma Site no 36; 🇺🇸 Fort Collins, Colorado, United States

Sunpharma Site no. 141; 🇺🇸 Avon Park, Florida, United States

Sunpharma site no. 21; 🇺🇸 Clearwater, Florida, United States

Sunpharma site no. 02; 🇺🇸 Hialeah, Florida, United States

Sunpharma Site no 55; 🇺🇸 Kissimmee, Florida, United States

Sunpharma Site no. 75; 🇺🇸 Margate, Florida, United States

Sunpharma site no. 05; 🇺🇸 New Port Richey, Florida, United States

Sunpharma Site no. 76; 🇺🇸 Ocoee, Florida, United States

SunPharma Site no 22; 🇺🇸 Tamarac, Florida, United States

Sunpharma Site no 46; 🇺🇸 Gainesville, Georgia, United States

Sunpharma Site no 41; 🇺🇸 Oak Brook, Illinois, United States

Sunpharma Site no 54; 🇺🇸 Orland Park, Illinois, United States

Sunpharma site no. 07; 🇺🇸 Worcester, Massachusetts, United States

Sunpharma Site no 45; 🇺🇸 Eagan, Minnesota, United States

Sunpharma Site no. 123; 🇺🇸 Saint Louis, Missouri, United States

Sunpharma site no. 14; 🇺🇸 Springfield, Missouri, United States

Sunpharma Site no 53; 🇺🇸 Kalispell, Montana, United States

Sunpharma Site no 27; 🇺🇸 Lincoln, Nebraska, United States

Sunpharma Site no 44; 🇺🇸 Voorhees, New Jersey, United States

Sunpharma Site no 52; 🇺🇸 Charlotte, North Carolina, United States

Sunpharma Site no. 73; 🇺🇸 Leland, North Carolina, United States

Sunpharma Site no 56; 🇺🇸 Wilmington, North Carolina, United States

Sunpharma Site no 33; 🇺🇸 Minot, North Dakota, United States

Sunpharma site no. 11; 🇺🇸 Middleburg Heights, Ohio, United States

Sunpharma Site no. 124; 🇺🇸 Oklahoma City, Oklahoma, United States

Sunpharma site no. 25; 🇺🇸 Wyomissing, Pennsylvania, United States

Sunpharma Site no 34; 🇺🇸 Greenville, South Carolina, United States

Sunpharma Site no 50; 🇺🇸 Austin, Texas, United States

Sunpharma site no. 13; 🇺🇸 Baytown, Texas, United States

Sunpharma Site no 49; 🇺🇸 Colleyville, Texas, United States

Sunpharma site no. 08; 🇺🇸 Houston, Texas, United States

Sunpharma site no. 04; 🇺🇸 League City, Texas, United States

Sunpharma Site no 28; 🇺🇸 Lubbock, Texas, United States

Sunpharma Site no. 74; 🇺🇸 Mesquite, Texas, United States

Sunpharma site no. 03; 🇺🇸 San Antonio, Texas, United States

Sunpharma site no. 16; 🇺🇸 San Antonio, Texas, United States

Sunpharma Site no 26; 🇺🇸 Stafford, Texas, United States

Sunpharma site no. 01; 🇺🇸 Tomball, Texas, United States

Sunpharma Site no. 121; 🇺🇸 Salt Lake City, Utah, United States

Sunpharma Site no. 81; 🇦🇺 Phillip, Australian Capital Territory, Australia

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, Czechia

Sunpharma Site no. 85; 🇪🇪 Tallinn, Estonia

Sunpharma site no. 102; 🇪🇪 Tallin, Estonia

Sunpharma Site no. 87; 🇪🇪 Tartu, Estonia

Sunpharma Site no. 86; 🇪🇪 Tartu, Estonia

Sunpharma Site no. 91; 🇩🇪 Berlin, Germany

Sunpharma Site no. 103; 🇩🇪 Herne, Germany

Sunpharma Site no. 128; 🇮🇳 Mylapore, Chennai, India

Sunpharma Site no. 134; 🇮🇳 Surat, Gujarat, 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. 131; 🇮🇳 Pune, Maharashtra, India

Sunpharma Site no. 142; 🇮🇳 Pune, Maharashtra, India

Sunpharma Site no. 135; 🇮🇳 Hyderabad, Telangana, India

Sunpharma Site no. 129; 🇮🇳 Lucknow, Uttar Pradesh, India

Sunpharma Site no. 104; 🇮🇹 Milan, Italy

Sunpharma Site no. 140; 🇮🇹 Milan, Italy

Sunpharma Site no. 138; 🇮🇹 Verona, Italy

Sunpharma Site no 69; 🇰🇷 Incheon, Korea, Republic of

Sunpharma Site no 71; 🇰🇷 Seoul, Korea, Republic of