deltatrials
Completed PHASE3 NCT00288704

Rilonacept for Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS)

IL1T-AI-0505: A Multi-center, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, & Efficacy of Rilonacept in Subjects With Cryopyrin-Associated Periodic Syndromes (CAPS) Using Parallel Group & Randomized Withdrawal Designs

Sponsor: Regeneron Pharmaceuticals

Conditions Familial Cold Autoinflammatory Syndrome (FCAS) Familial Cold Urticaria Genetic Diseases, Inborn Muckle-Wells Syndrome (MWS)
Interventions Placebo rilonacept 160 mg
Updated 8 times since 2017 Last updated: Dec 1, 2011 Started: Dec 31, 2005 Primary completion: Jun 30, 2008 Completion: Aug 31, 2008

Listed as NCT00288704, this PHASE3 trial focuses on Familial Cold Autoinflammatory Syndrome (FCAS) and Familial Cold Urticaria and remains completed. Sponsored by Regeneron Pharmaceuticals, it has been updated 8 times since 2005, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshotCompleted~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 7 months · monthly snapshotCompleted

Change History

8 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Dec 2021 — Jul 2024 [monthly]

    Completed PHASE3

  5. Jan 2021 — Dec 2021 [monthly]

    Completed PHASE3

▶ Show 3 earlier versions

  1. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE3

  2. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE3

  3. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE3

    First recorded

Dec 2005

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Regeneron Pharmaceuticals
Data source: Regeneron Pharmaceuticals

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Atlanta, United States , Aurora, United States , Cedar City, United States , Chattanooga, United States , Chesterfield, United States , Cincinnati, United States , Columbia, United States , Columbus, United States , Dallas, United States , Duncansville, United States and 14 more locations