Clinical Trials List
2020-12-31 - 2023-12-31
Phase III
Recruiting9
ICD-10L40.50
Arthropathic psoriasis, unspecified
ICD-10L40.51
Distal interphalangeal psoriatic arthropathy
ICD-10L40.52
Psoriatic arthritis mutilans
ICD-10L40.53
Psoriatic spondylitis
ICD-10L40.54
Psoriatic juvenile arthropathy
ICD-10L40.59
Other psoriatic arthropathy
ICD-9696.0
Psoriatic arthropathy
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of Tildrakizumab in Anti-TNF Experienced Subjects with Active Psoriatic Arthritis I (INSPIRE 1)
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Trial Applicant
IQVIA RDS Taiwan Ltd.
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Sponsor
Sun Pharma Global FZE
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chih-Chiang Chen Division of Dermatology
- 何翊芯 無
- 曹彥博 風濕免疫科
- DINGDAR LEE 無
- Cheng-Yuan Li Division of Dermatology
- Ming-Han Chen 無
- 吳貞宜 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 黃建中 風濕免疫科
- Po-Hao Huang 風濕免疫科
- 洪偉哲 風濕免疫科
- 邱瑩明 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 黃瑞雲 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 林育志 無
- Jeng-Hsien Yen 無
- 歐燦騰 無
- Wen Chan Tsai 無
- Sung Wan-Yu 無
- Chia-Chun Tseng 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
• The proportion of subjects who achieve ACR20 at Week 24 Key Secondary Efficacy Endpoints:
• The proportion of subjects achieving ACR50 at Week 24
• The proportion of subjects achieving ACR70 at Week 24
• The proportion of subjects achieving PASI75 response at Weeks 24 among subjects with BSA ≥3% at baseline
• The change from Baseline in the van der Heijde modified total Sharp score at Week 24
• The change from Baseline in the van der Heijde modified total Sharp score at Week 16
Inclution Criteria
2. Subject is ≥ 18 years of age at time of Screening.
3. Subject has a diagnosis of active PsA (by the Classification of PsA criteria, APPENDIX 1) for at least 6 months
before the first administration of the study agent and has active PsA at Screening or Baseline.
4. Subject has ≥ 3 tender and ≥ 3 swollen joints at Screening and Baseline (dactylitis of a digit counts as one joint
each).
5. Rheumatoid factor (RF) and anti-cyclic citrullinated peptide antibodies (anti-CCP Ab) negative.
6. Diagnosis of active plaque PsO, with at least one psoriatic plaque of ≥2 cm diameter at Screening or a
documented history of plaque PsO.
7. Subjects must have prior exposure to anti-tumor necrosis factor (anti-TNF) agent(s) use for the treatment of
PsO or PsA.
8. For subjects receiving non-steroidal anti-inflammatory drugs (NSAIDs) or low potency opioids (e.g. only
tramadol, meperidine, and codeine allowed), including as needed (PRN) use: the subject must be on a stable
dose for ≥ 4 weeks prior to initiation of IMP and be expected to maintain a stable dose for the first 24 weeks
of the study, unless a change in dosage is required due to toxicity. Stable dose and PRN use are defined as
subjects taking an NSAID or low- potency- opioids on average 4 days per week over the 4-week period prior
to Screening.
9. For subjects receiving non-drug therapy (including but not limited to physical therapy, massage, diet, exercise,
emollients, and joint taping), this must be stable for the 4-week period prior to IMP initiation through to the
end of Study Period.
10. For subjects receiving methotrexate (MTX) or leflunomide: subject has received treatment for at least
3 months, with a stable dose and method of dosing (methotrexate: oral or subcutaneous injection; leflunomide:
oral) (not to exceed 25 mg MTX per week or 20 mg leflunomide per day) for at least 8 weeks prior to initiation
of IMP, and be expected to maintain a stable dose for the first 24 weeks of the study, unless change in dosage
is required due to toxicity. Subjects may not be receiving both leflunomide and MTX concomitantly.
11. For subjects receiving oral corticosteroids: the subject must be on a stable dose (not to exceed the equivalent
of 10 mg of prednisone per day) for ≥ 4 weeks prior to initiation of IMP, and be expected to maintain a stable
dose for the first 24 weeks of the study.
12. Subject has a negative evaluation for tuberculosis (TB) within 4 weeks before initiating IMP, defined as a
negative QuantiFERON test. Subjects with a positive or 2 successive indeterminate QuantiFERON tests are
allowed if they have all of the following:
− no history of active TB or symptoms of TB,
− a posterior-anterior (PA) chest radiograph (with associated report available at the site) performed
within 3 months of Screening with no evidence of active TB (or of any other pulmonary infectious
diseases),
− if prior latent TB infection, must have history of adequate prophylaxis (per local standard of care),
− if presence of latent TB is established, then treatment according to local country guidelines must have
been followed for at least 4 weeks, prior to dosing in the study
Exclusion Criteria
Other medical conditions:
1. Subject has a planned surgical intervention between Baseline and the Week 52 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 intravenous (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. Major chronic inflammatory or connective tissue disease other than PsA (e.g., rheumatoid arthritis (RA),
systemic lupus erythematosus (SLE), ankylosing spondylitis, Lyme disease, Sjogren’s disease, mixed
connective tissue disease, scleroderma, or gout that might confound the evaluation of the benefit of
tildrakizumab therapy as judged by the investigator); PsA with spondylitis and/or sacroiliitis is permitted.
4. Subject has any concurrent medical condition or uncontrolled, clinically significant systemic disease (e.g.,
renal failure, heart failure, hypertension, liver disease, diabetes, or anemia) that, in the opinion of the
Investigator, could cause this study to be detrimental to the subject.
5. Subject has a known history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.
6. Subject had myocardial infarction, unstable angina pectoris, or ischemic stroke within the past 6 months prior
to the first IMP dose.
7. Subject has any active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or
melanoma.
8. 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.
9. Subjects with a history of alcohol or drug abuse in the previous 2 years.
10. Significant risk of suicidality at the Screening assessment based on the Investigator’s judgment or, if
appropriate, as indicated by a response of “yes” within the last 12 months to question 4 or 5 in the suicidal
section, or any response in the behavioral section of the Columbia-Suicide Severity Rating Scale (C-SSRS).
The Estimated Number of Participants
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Taiwan
20 participants
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Global
472 participants
