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)

Sun Pharmaceutical Industries Limited148 个研究点分布在 12 个国家目标入组 508 人2020年7月1日

适应症Active Psoriatic Arthritis

干预措施TILD matching placebo injections

相关药物TILD matching placebo injections

概览

阶段: 3 期
干预措施: TILD
疾病 / 适应症: Active Psoriatic Arthritis
发起方: Sun Pharmaceutical Industries Limited
入组人数: 508
试验地点: 148
主要终点: The proportion of subjects who achieve American College of Rheumatology [ACR20]
状态: 已完成
最后更新: 3个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

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)

注册库

clinicaltrials.gov

开始日期

2020年7月1日

结束日期

2025年12月22日

最后更新

3个月前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Sun Pharmaceutical Industries Limited

责任方

Sponsor

入排标准

入选标准

•Subject has provided written informed consent.
•Subject is ≥ 18 years of age at time of Screening.
•RF and anti-CCP Ab negative.
•Subjects must have prior exposure to anti-TNF agent(s) use for the treatment of PsO or PsA.

排除标准

•Subject has a planned surgical intervention between Baseline and the Week 24 evaluation for a pretreatment condition.
•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.
•Subject has a known history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.
•Subject had myocardial infarction, unstable angina pectoris, or ischemic stroke within the past 6 months prior to the first IMP dose.
•Subject has any active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma.
•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.
•Subjects with a history of alcohol or drug abuse in the previous 2 years.

研究组 & 干预措施

Arm A

干预措施: TILD

Arm B

干预措施: matching placebo injections

结局指标

主要结局

The proportion of subjects who achieve American College of Rheumatology [ACR20]

时间窗: at week 24

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

次要结局

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)
The change from Baseline in subjects with active Psoriasis and Body surface area ≥ 3% ("those with involvement of nails" )(at Week 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)
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 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)
Change from Baseline in American College of Rheumatology Response Criteria Components Score(at Week 24)
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 change from Baseline in American College of Rheumatology Response Criteria Components Score(at Week 52)
The change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index(at Week 52)
The change from Baseline(at Week 52)
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)
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)
The change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scores(at Week 24)
The change from Baseline in the van der Heijde modified total Sharp score(at Week 24)
The change from Baseline in van der Heijde modified Sharp sub-scores (erosion score and joint space narrowing score)(at Week 24)