deltatrials
Completed PHASE2 INTERVENTIONAL 7-arm NCT03926611

This Was a Dose-finding Study to Evaluate Efficacy and Safety of LOU064 in Patients With CSU Inadequately Controlled by H1-antihistamines

A Multicenter, Randomized, Double-blind, Placebo- Controlled Phase 2b Dose-finding Study to Investigate the Efficacy, Safety and Tolerability of LOU064 in Adult Chronic Spontaneous Urticaria (CSU) Patients Inadequately Controlled by H1-antihistamines

Sponsor: Novartis Pharmaceuticals

Conditions Chronic Spontaneous Urticaria
Interventions LOU064 Arm 1 LOU064 Arm 2 LOU064 Arm 3 LOU064 Arm 4 LOU064 Arm 5 LOU064 Arm 6 Placebo arm
Updated 20 times since 2019 Last updated: Apr 27, 2022 Started: Jun 6, 2019 Primary completion: Jan 14, 2021 Completion: Apr 15, 2021
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2 clinical study on Chronic Spontaneous Urticaria, this trial is completed. The trial is conducted by Novartis Pharmaceuticals and has accumulated 20 data snapshots since 2019. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~May 2019 – ~Aug 2019 · 3 months · monthly snapshot~Aug 2019 – ~Nov 2019 · 3 months · monthly snapshot~Nov 2019 – ~Mar 2020 · 4 months · monthly snapshot~Mar 2020 – ~Apr 2020 · 31 days · monthly snapshot~Apr 2020 – ~May 2020 · 30 days · monthly snapshot~May 2020 – ~Jun 2020 · 31 days · monthly snapshot~Jun 2020 – ~Jul 2020 · 30 days · monthly snapshot~Jul 2020 – ~Sep 2020 · 2 months · monthly snapshot~Sep 2020 – ~Dec 2020 · 3 months · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~Apr 2021 · 3 months · monthly snapshot~Apr 2021 – ~Jun 2021 · 2 months · monthly snapshot~Jun 2021 – ~Sep 2021 · 3 months · monthly snapshot~Sep 2021 – ~Jan 2022 · 4 months · monthly snapshot~Jan 2022 – ~Mar 2022 · 59 days · monthly snapshot~Mar 2022 – ~May 2022 · 2 months · monthly snapshot~May 2022 – ~Jul 2024 · 26 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 11 months · monthly snapshot

Change History

20 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE2

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. May 2022 — Jul 2024 [monthly]

    Completed PHASE2

  5. Mar 2022 — May 2022 [monthly]

    Completed PHASE2

▶ Show 15 earlier versions

  1. Jan 2022 — Mar 2022 [monthly]

    Completed PHASE2

  2. Sep 2021 — Jan 2022 [monthly]

    Completed PHASE2

  3. Jun 2021 — Sep 2021 [monthly]

    Completed PHASE2

    Status: Active Not Recruiting → Completed

  4. Apr 2021 — Jun 2021 [monthly]

    Active Not Recruiting PHASE2

    Status: Recruiting → Active Not Recruiting

  5. Jan 2021 — Apr 2021 [monthly]

    Recruiting PHASE2

  6. Dec 2020 — Jan 2021 [monthly]

    Recruiting PHASE2

  7. Sep 2020 — Dec 2020 [monthly]

    Recruiting PHASE2

  8. Jul 2020 — Sep 2020 [monthly]

    Recruiting PHASE2

    Status: Suspended → Recruiting

  9. Jun 2020 — Jul 2020 [monthly]

    Suspended PHASE2

    Status: Recruiting → Suspended

  10. May 2020 — Jun 2020 [monthly]

    Recruiting PHASE2

  11. Apr 2020 — May 2020 [monthly]

    Recruiting PHASE2

  12. Mar 2020 — Apr 2020 [monthly]

    Recruiting PHASE2

  13. Nov 2019 — Mar 2020 [monthly]

    Recruiting PHASE2

  14. Aug 2019 — Nov 2019 [monthly]

    Recruiting PHASE2

    Status: Not Yet Recruiting → Recruiting

  15. May 2019 — Aug 2019 [monthly]

    Not Yet Recruiting PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Novartis Pharmaceuticals
Data source: Novartis

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

Study Locations

Alicante, Spain , Amsterdam, Netherlands , Arhus C, Denmark , Barcelona, Spain , Berlin, Germany , Budapest, Hungary , CABA, Argentina , Copenhagen NV, Denmark , Debrecen, Hungary , Denizli, Turkey (Türkiye) and 62 more locations