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NCT06611163 · ClinicalTrials.gov registry record · Phase 3

A Study to Evaluate the Efficacy and Safety of Subcutaneous Tildrakizumab in Subjects With Moderate to Severe Genital Psoriasis.

A Phase 3 study of Moderate to Severe Genital Psoriasis, sponsored by Sun Pharmaceutical Industries Limited.

Active
Registry status
Phase 3
Development phase
206
Enrollment target
20
Study locations

NCT06611163: Active Phase 3 study of Moderate to Severe Genital Psoriasis, sponsored by Sun Pharmaceutical Industries Limited.

NCT06611163 is a Phase 3 study of Moderate to Severe Genital Psoriasis that is active but no longer recruiting, run by Sun Pharmaceutical Industries Limited. The registered enrollment target is 206 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06611163, a Phase 3 study of Moderate to Severe Genital Psoriasis, is active but no longer recruiting, sponsored by Sun Pharmaceutical Industries Limited.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
206 participants
Enrollment target
20
Study locations

Study Summary

Phase 3 study to evaluate the efficacy and safety of subcutaneous tildrakizumab in subjects with moderate to severe genital psoriasis.

Primary Outcome

The modified sPGA-G is a 5-point scale ranging from clear (0), almost clear (1), mild (2), moderate (3), to severe (4) and incorporates an assessment of the severity of the three primary signs of the disease: erythema, elevation, and scaling. Higher scores indicate greater disease severity.

Interventions

  • DRUG Placebo
  • DRUG Tildrakizumab 100 mg

Study Locations (20)

California

  • Smary Cures Clinical Research - Anaheim
  • California Dermatology & Clinical Research Institute - Encinitas
  • T. Joseph Raoof MD, Inc./Encino Research Center - Encino
  • Center for Dermatology Clinical Research, Inc - Fremont
  • Dermatology Research Associates - Los Angeles
  • LA Universal Research Center Inc, Suite 1 - Los Angeles
  • Amicis Research Center - Northridge
  • Therapeutics Clinical Research - San Diego
  • Dermatology Institute and Skin Care Center, Inc. DBA Clinical Science Institute - Santa Monica

Florida

  • Coral Gables Dermatology & Aesthetics - Coral Gables
  • Florida Academic Centers Research and Education, LLC - Coral Gables
  • Homestead Associates in Research Inc - Homestead
  • Genomics Medical Research - Miami
  • Med-Care Research - Miami

Georgia

  • Dermatology Affiliates Research Institute, LLC - Atlanta
  • Mcintosh Clinic, PC - Thomasville

Michigan

  • Oakland Hills Dermatology PC - Auburn Hills
  • The Derm Institute of West Michigan - Caledonia

Colorado

  • Paradigm Clinical Research - Wheat Ridge

Indiana

  • The Indiana Clinical Trials Center - Plainfield

Trial Details

FieldValue
Enrollment Target 206 participants
Start Date 2025-03-21
Est. Completion 2027-02
Phase Phase 3

What the registry record for NCT06611163 still lists

NCT06611163 is an interventional study that assigns participants to a tested intervention. The registered 206 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower).

The record links to 1 condition, with Moderate to Severe Genital Psoriasis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT06611163 names 20 study sites across 6 states, led by California, Florida, Georgia.

Frequently Asked Questions

What is clinical trial NCT06611163 about?

NCT06611163 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Subcutaneous Tildrakizumab in Subjects With Moderate to Severe Genital Psoriasis.". Phase 3 study to evaluate the efficacy and safety of subcutaneous tildrakizumab in subjects with moderate to severe genital psoriasis.

What is the current status of trial NCT06611163?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 206 participants. The study started on 2025-03-21. Estimated completion is 2027-02.

What conditions does trial NCT06611163 study?

This clinical trial studies the following conditions: Moderate to Severe Genital Psoriasis.

What interventions are being tested in trial NCT06611163?

The interventions under investigation include: Placebo (DRUG), Tildrakizumab 100 mg (DRUG).

Who is sponsoring clinical trial NCT06611163?

This trial is sponsored by Sun Pharmaceutical Industries Limited, which has 38 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06611163 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Georgia, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT06611163's enrollment target sits among peer trials

206 1348th of 2000 higher than 651 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06611163, the US trial registry maintained by the National Library of Medicine. NCT06611163 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.