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Long Term Evaluation of Safety and Efficacy of Tildrakizumab in Patients With Psoriatic Arthritis

PHASE3RECRUITING

An open label phase 3 study.

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Study details:

Subjects from both INSPIRE 1 (TILD-19-07) and INSPIRE 2 (TILD-19-19) studies to roll over into this INSPIRE LTE study (TILD-21-01).

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Subjects possess the ability to understand the requirements of the study.

Subject has provided written informed consent as evidenced by signature on an informed consent form approved by an institutional review board/EC.

Agree to abide by the study restrictions, scheduled treatment, laboratory assessments, other study procedures and return to the site for the required assessments.

Subject with PsA who had met all eligibility criteria for the parent study, had completed the parent study treatment period and has not developed any parent protocol criteria for premature discontinuation of treatment or withdrawal from the study.

Exclusion criteria

Female subjects of childbearing potential who do not agree to abstain from heterosexual activity or practice a dual method of contraception.

Female is pregnant or breastfeeding, or planning to become pregnant or initiate breastfeeding while enrolled in the study or up to 17 weeks after the last dose of IMP.

Subject has previously been enrolled in this long-term extension study.

Any condition that in the opinion of the Investigator represents an obstacle for study conduct and/or represents a potential unacceptable risk for the subject.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2022-06-30

Primary completion: 2028-12-01

Study completion finish: 2029-04-01

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT04991116

Intervention or treatment

DRUG: TILD sub-cutaneous (SC) injection

Conditions

• Psoriatic Arthritis

Condition: Psoriatic Arthritis
DRUG: TILD sub-cutaneous (SC) injection
Phillip, Australian Capital Territory, Australia and more
Sponsor: Sun Pharmaceutical Industries Limited

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Sunpharma site no 59

Research sites nearby

Select from list below to view details:

Sunpharma site no 59
Phillip, Australian Capital Territory, Australia
Sunpharma site no 58
Maroochydore, Queensland, Australia
Sunpharma site no. 24
Hobart, Tasmania, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: TILD q12 weeks Not Specified	DRUG: TILD sub-cutaneous (SC) injection 1 mL injection of study medication

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Incidence and intensity of Adverse Events (AEs) recorded through the study period	Not Specified	Week 124
Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20	ACR20 response is an aggregate of: 1. at least 20% reduction in tender joint count and swollen joint count and at least 3 of the following 5 assessments: 1. physician's global assessment of disease activity 2. patient's global assessment of disease activity 3. patient's assessment of pain 4. patient's self-assessed disability based on health assessment questionnaire 5. c-reactive protein	Week 124
Proportion of Subjects Who Reached (American College of Rheumatology Score of 50) ACR50	ACR50 response is an aggregate of: 1. at least 50% reduction in tender joint count and swollen joint count and at least 3 of the following 5 assessments: 1. physician's global assessment of disease activity 2. patient's global assessment of disease activity 3. patient's assessment of pain 4. patient's self-assessed disability based on health assessment questionnaire 5. c-reactive protein	Week 124
Proportion of Subjects Who Reached (American College of Rheumatology Score of 70) ACR70	ACR70 response is an aggregate of: 1. at least 70% reduction in tender joint count and swollen joint count and at least 3 of the following 5 assessments: 1. physician's global assessment of disease activity 2. patient's global assessment of disease activity 3. patient's assessment of pain 4. patient's self-assessed disability based on health assessment questionnaire 5. c-reactive protein	Week 124

Secondary outcome

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

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References

Clinical Trials Gov: Long Term Evaluation of Safety and Efficacy of Tildrakizumab in Patients With Psoriatic Arthritis