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A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of Tildrakizumab in Anti-TNF Naive Subjects with Active Psoriatic Arthritis II (INSPIRE 2)

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512142-42-00
Acronym
TILD-19-19
Enrollment
108
Registered
2024-06-27
Start date
2021-10-05
Completion date
2025-04-10
Last updated
2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriatic Arthritis

Brief summary

The proportion of subjects who achieve ACR20 at Week 24

Detailed description

The proportion of subjects achieving ACR50 at Week 24, The change from baseline in HAQ-DI at Week 24., The proportion of subjects achieving PASI75 response at Week24 among subjects with BSA ≥3% at baseline, The proportion of subjects achieving ACR70 at Week 24, 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

Interventions

Sponsors

Sun Pharmaceutical Industries Limited, Iqvia Biotech Limited, Labcorp Central Laboratory Services SARL
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The proportion of subjects who achieve ACR20 at Week 24

Secondary

MeasureTime frame
The proportion of subjects achieving ACR50 at Week 24, The change from baseline in HAQ-DI at Week 24., The proportion of subjects achieving PASI75 response at Week24 among subjects with BSA ≥3% at baseline, The proportion of subjects achieving ACR70 at Week 24, 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

Countries

Czechia, Germany, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026