NCT04548869

A Single Dose Study of the Safety, Pharmacokinetics and Pharmacodynamics of CDX-0159 in Patients With Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria

Completed Phase 1 Last updated 17 May 2023

What this trial tests

Phase 1 trial testing CDX-0159 in Cold Urticaria in 41 participants. Completed in 12 May 2023.

Timeline

24 November 2020

Primary endpoint
16 December 2022

12 May 2023

Quick facts

Lead sponsor	Celldex Therapeutics
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	41
Start date	24 November 2020
Primary completion	16 December 2022
Estimated completion	12 May 2023
Sites	1 location across Germany

Drugs / interventions tested

• CDX-0159 — full drug profile →

Conditions studied

• Cold Urticaria — all drugs for Cold Urticaria →
• Cold Contact Urticaria — all drugs for Cold Contact Urticaria →
• Symptomatic Dermographism — all drugs for Symptomatic Dermographism →
• Symptomatic Dermatographism — all drugs for Symptomatic Dermatographism →

Sponsor

Celldex Therapeutics — full company profile →

Who can join

Adults 18 to 75, any sex, with Cold Urticaria or Cold Contact Urticaria. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a study to determine the safety of CDX-0159 in patients with Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria.

Publications & conference data

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

1. KIT as a master regulator of the mast cell lineage.
   Tsai M, Valent P, Galli SJ. · · 2022 · cited 85× · PMID 35469840 · DOI 10.1016/j.jaci.2022.04.012
2. Anti-KIT monoclonal antibody CDX-0159 induces profound and durable mast cell suppression in a healthy volunteer study.
   Alvarado D, Maurer M, Gedrich R, Seibel SB, et al · · 2022 · cited 54× · PMID 35184297 · DOI 10.1111/all.15262
3. Mast cells: a novel therapeutic avenue for cardiovascular diseases?
   Poto R, Marone G, Galli SJ, Varricchi G. · · 2024 · cited 27× · PMID 38630620 · DOI 10.1093/cvr/cvae066
4. Human Lung Mast Cells: Therapeutic Implications in Asthma.
   Poto R, Criscuolo G, Marone G, Brightling CE, et al · · 2022 · cited 26× · PMID 36430941 · DOI 10.3390/ijms232214466
5. 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
6. 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