Efficacy and Safety of Tildrakizumab Compared to Placebo in Anti-TNF naïve Subjects With Active Psoriatic Arthritis II (INSPIRE 2)

ClinicalTrials.gov ID: NCT04314531

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Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a randomized, double-blinded, placebo-controlled, Phase 3 study to evaluate the efficacy and safety of tildrakizumab compared to placebo in anti-TNF naïve subjects with active PsA .

Study identification

NCT ID: NCT04314531
Recruitment status: Active, not recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Sun Pharmaceutical Industries Limited; Industry
Enrollment: 296 participants

Conditions and interventions

Conditions

Active Psoriatic Arthritis

Interventions

TILD Drug
matching placebo injections Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jul 1, 2020 (Actual)
Primary completion: Jun 4, 2025 (Actual)
Completion: Apr 2026 (Estimated)
Last update posted: Mar 10, 2026

2020 – 2026

United States locations

U.S. sites: 11
U.S. states: 7
U.S. cities: 11

Facility	City	State	ZIP	Site status
Sunpharma site no. 12	Covina	California	91722	—
Sunpharma site no. 04	Miami Beach	Florida	33140	—
Sunpharma site no. 02	New Port Richey	Florida	34652	—
Sunpharma site no. 07	Tamarac	Florida	33321	—
Sunpharma site no. 05	Springfield	Missouri	65810	—
Sunpharma site no. 10	Lincoln	Nebraska	68516	—
Sunpharma site no. 11	Greenville	South Carolina	29601	—
Sunpharma site no. 09	Lubbock	Texas	79410	—
Sunpharma site no. 03	San Antonio	Texas	78229	—
Sunpharma site no. 01	Tomball	Texas	77375	—
Sunpharma site no. 06	Spokane	Washington	99204	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 38 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT04314531, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Mar 10, 2026 · Synced Nov 14, 2026