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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
Phase 1 trial testing Oral EP262 in Chronic Inducible Urticaria in 33 participants. Completed in 22 October 2024.
22 October 2024
Quick facts
| Lead sponsor | Escient Pharmaceuticals, Inc |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 33 |
| Start date | 30 August 2023 |
| Primary completion | 22 October 2024 |
| Estimated completion | 22 October 2024 |
| Sites | 15 locations across Netherlands, Germany, Canada, United States, Spain |
Drugs / interventions tested
- Oral EP262 — full drug profile →
Conditions studied
- Chronic Inducible Urticaria — all drugs for Chronic Inducible Urticaria →
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):
-
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT06050928
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Oral EP262
Trials testing the same drug.
- NCT06144424 — Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics · Phase 2 · completed
- NCT06077773 — Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects Wi · Phase 2 · terminated
Other recruiting trials for Chronic Inducible Urticaria
Currently open trials in the same condition.
- NCT06931405 — Study of BLU-808 in Chronic Inducible Urticaria (CIndU) and Chronic Spontaneous Urticaria (CSU) · Phase 2 · recruiting
- NCT05976243 — A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Ina · Phase 3 · active not recruiting
Other Escient Pharmaceuticals, Inc trials
Trials by the same sponsor.
- NCT06645704 — An Open-Label Phase 1 Study in Healthy Male Subjects to Investigate the Absorption, Metabolism and Excretion of [14C]-EP · Phase 1 · completed
- NCT06144424 — Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics · Phase 2 · completed
- NCT06077773 — Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects Wi · Phase 2 · terminated
- NCT05525520 — Study to Evaluate EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing C · Phase 2 · completed
- NCT04510090 — Evaluate the Safety, Tolerability, and PK of EP547 in Healthy Subjects and Subjects With Cholestatic or Uremic Pruritus · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06050928 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Escient Pharmaceuticals, Inc
- Last refreshed: 9 December 2024
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