GTX-B001 in healthy people and adults with chronic inducible urticaria

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

GTX-B001 is a humanized bispecific antibody designed to bind c-Kit and CD203c on mast cells to limit their activation. This randomized, double-blind, placebo-controlled, first-in-human Phase 1 study administers a single IV dose and follows participants for 12 weeks to characterize safety, pharmacokinetics, and pharmacodynamics. Part A will enroll about 48 healthy adults across five ascending dose cohorts, while Part B will enroll about 24 symptomatic patients across two ascending cohorts to also explore preliminary efficacy. Patients in Part B must have positive provocation tests (TempTest for cold urticaria or FricTest for symptomatic dermographism) and inadequate control on second‑generation H1 antihistamines.

Why it matters

Who can join: the full rules

Key inclusion Criteria (Part A):

* The subject is between 18 and 55 years of age (both inclusive) at the date of screening.
* The subject is in good general health based on the medical history, physical examination and the results of vital signs, electrocardiogram and clinical laboratory, as judged by the investigator.

Key inclusion Criteria (Part B):

* The subject is between 18 and 75 years of age (both inclusive) at the date of screening
* A history of signs and/or symptoms of ColdU or SD experienced ≥ 3 months prior to screening.
* For ColdU patients, a positive provocation test during screening and baseline, using the TempTest® device.
* For SD patients, a positive provocation test with at least 3 pins during screening and baseline, using the FricTest® device.
* Inadequate control of ColdU or SD by second generation H1-antihistamine (sgAH) as defined as the presence of itch and hives following a trigger (e.g. cold or scratching, respectively) within the last 6 weeks prior to screening in spite of use of a sgAH.
* A Urticaria Control Test (UCT) score of \< 12 at screening.

Key exclusion Criteria (Parts A \& B):

* Presence of any clinically significant illness, such as cardiovascular, neurologic, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, or endocrine disease or disorder that would interfere with the patient's safety or the interpretation of trial results in the judgment of the investigator.
* Treatment with an investigational drug or intervention for any condition within three months of screening, or concurrent participation in another clinical trial in which an investigational drug is administered.
* Treatment with immunomodulating therapy (e.g., intravenous or intramuscular immunoglobulins, systemic corticosteroids, cyclosporine, methotrexate, dapsone, cyclophosphamide, tacrolimus, mycophenolate mofetil, hydroxychloroquine, infliximab, adalimumab, etanercept, etc.) within 4 weeks (or 5 half-lives, whichever is longer) prior to screening.
* Use of any monoclonal antibody or therapeutic protein within 4 weeks (or 5 half-lives, whichever is longer) prior to screening.
* History of anaphylaxis, autoimmune disorders requiring more than topical medication, or asthma requiring regular use of inhaled medication within the past 5 years, unless, in the opinion of the Investigator, the condition is not considered clinically significant and is unlikely to affect subject safety or study outcomes.

Additionally for Part B:

* Disease with symptoms of urticaria or angioedema other than Chronic Urticaria (CU), for example urticaria vasculitis, erythema multiforme, mastocytosis, or drug-induced urticaria. Patients with concomitant Chronic Spontaneous Urticaria (CSU) or other forms of Chronic Inducible Urticaria (CIndU) are eligible provided that symptoms at screening are consistent with ColdU or SD and that ColdU or SD is the dominant form of CU.
* Any other skin disease associated with chronic itching that might influence in the investigators' opinion of the study evaluations and results, e.g., atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, or psoriasis.
* Receipt of any biologic therapy for urticaria control (e.g. omalizumab, dupilumab, ligelizumab, etc.) within three months of screening (whether on-label or off-label).

Where it's running

• Charite Universitaetsmedizin Berlin
  Berlin, Germany Recruiting
• Dermatologische Praxis
  Halle, Germany Recruiting
• Universitaetsklinikum Giessen und Marburg GmbH
  Marburg, Germany Recruiting
• Universitatsklinikum Münster
  Münster, Germany Recruiting
• Charité Research Organization gmbh
  Berlin, Germany Active not recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.