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NCT06050928: CALM-CIndU

Phase 1b, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of EP262 in Subjects With Chronic Inducible Urticaria

Completed Phase 1 Last updated 9 December 2024
What this trial tests

Phase 1 trial testing Oral EP262 in Chronic Inducible Urticaria in 33 participants. Completed in 22 October 2024.

Timeline
30 August 2023
Primary endpoint
22 October 2024
22 October 2024

Quick facts

Lead sponsorEscient Pharmaceuticals, Inc
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment33
Start date30 August 2023
Primary completion22 October 2024
Estimated completion22 October 2024
Sites15 locations across Netherlands, Germany, Canada, United States, Spain

Drugs / interventions tested

Conditions studied

Sponsor

Escient Pharmaceuticals, Inc — full company profile →

Who can join

Adults 18 to 80, any sex, with Chronic Inducible Urticaria. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase 1b trial will evaluate the effects of EP262 in subjects with Chronic Inducible Urticaria (CIndU), including symptomatic dermographism and cold urticaria.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. New insights into chronic inducible urticaria.
    Muñoz M, Kiefer LA, Pereira MP, Bizjak M, et al · · 2024 · cited 13× · PMID 39028396 · DOI 10.1007/s11882-024-01160-y
  2. Update on the Treatment of Chronic Spontaneous Urticaria.
    Kolkhir P, Fok JS, Kocatürk E, Li PH, et al · · 2025 · cited 10× · PMID 40074986 · DOI 10.1007/s40265-025-02170-4
  3. Therapies for Chronic Spontaneous Urticaria: Present and Future Developments.
    Asero R, Calzari P, Vaienti S, Cugno M. · · 2024 · cited 10× · PMID 39598410 · DOI 10.3390/ph17111499
  4. IgE and non-IgE-mediated pathways in anaphylaxis.
    Worm M, Pazur K, Morakabati P, Redhu D. · · 2025 · cited 5× · PMID 40802080 · DOI 10.1007/s00281-025-01056-7
  5. No allergy, but mast cells are involved: MRGPRX2 in chronic inflammatory skin diseases.
    Metz M. · · 2025 · cited 3× · PMID 39996342 · DOI 10.1111/jdv.20541
  6. Functional heterogeneity of mast cells in cutaneous inflammation: implications for precision medicine.
    A S, Ulzii D, Yadamsuren E, Shi J. · · 2025 · cited 1× · PMID 41164192 · DOI 10.3389/fimmu.2025.1680574
  7. Advancements and challenges in the management of chronic inducible urticaria.
    Zhang M, Liu J, Zhi Y. · · 2026 · PMID 42112401 · DOI 10.3389/fimmu.2026.1747542
  8. The MRGPRX2 paradigm shift: Redefining mast cell activation pathways in chronic urticaria.
    Wu K, Liu J. · · 2026 · PMID 42058742 · DOI 10.5414/alx02618e

Verify or expand the search:

Other trials of Oral EP262

Trials testing the same drug.

Other recruiting trials for Chronic Inducible Urticaria

Currently open trials in the same condition.

Other Escient Pharmaceuticals, Inc trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06050928.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing