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

NCT04548869 | Completed Phase 1 FDA Drug

• 2 other identifiers: CDX0159-032020-002792-35
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cold Urticaria; Cold Contact Urticaria; Symptomatic Dermographism; Symptomatic Dermatographism; Cholinergic Urticaria

Outcome Measures

Primary Outcomes (1)

• Safety as assessed by the incidence and severity of adverse events

  Safety of a single dose of CDX-0159 as determined by adverse events

  From Day 1 through week 12

Secondary Outcomes (8)

• For patients with Cold Contact Urticaria, Change in Critical Temperature Thresholds (CTT)

  From Day 1 to Day 85

• For patients with Symptomatic Dermographism, change in provocation thresholds

  From Day 1 to Day 85

• For patients with Cholinergic Urticaria, changes in baseline Urticaria Activity Score Provocation (UASprovo)

  From Day 1 to Day 85

• Changes from baseline in Urticaria Control Test (UCT)

  From Day 1 to Day 85

• Blood Biomarkers

  From Day 1 to Day 85

Study Arms (1)

CDX-0159

EXPERIMENTAL

20 patients with Cold Contact Urticaria, 10 patients with Symptomatic Dermographism, and 10 patients with Cholinergic Urticaria will be enrolled and treated with a single dose of CDX-0159

Drug: CDX-0159

Interventions

CDX-0159 DRUG

Administered intravenously

CDX-0159

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria which does not respond to antihistamines
• Diagnosis for ≥ 3 months; symptoms of both hive (wheal) and itch/burning/painful sensation despite concurrent use of anti-histamines
• During screening, in clinic, for Cold Contact Urticaria, patients must have a positive cold stimulation test, for Symptomatic Dermographism, patients must have a positive FricTest®, and for Cholinergic Urticaria, patients must have a positive pulse-controlled ergometry (PCE) provocation test
• On stable dose of antihistamines
• Other than a diagnosis of Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria, no other conditions which would introduce additional risk factors or would interfere with the study procedures, as determined by the investigator, based on a medical evaluation
• Female and male patients must use highly effective contraception from the time of the screening visit and for at least 150 days after receipt of study treatment
• Willing and able to comply with all study requirements and procedures including completion of a daily medication diary and questionnaires

You may not qualify if:

• A clearly defined diagnosis of hives or angioedema other than chronic urticaria.
• Receipt of prior biologic therapy (e.g.: omalizumab, dupilumab, ligelizumab) within past 3 months
• Treatment with immunosuppressives (e.g. systemic corticosteroids, cyclosporine, methotrexate, dapsone, cyclophosphamide, tacrolimus and mycophenolate mofetil, hydroxychloroquine or others) within 4 weeks or 5 half lives
• Active COVID-19 infection
• HIV, hepatitis B or hepatitis C infection
• There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.

Sponsors & Collaborators

• Celldex Therapeutics: lead

Study Sites (1)

Charite University

Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Cold Urticaria; Familial dermographism

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 16, 2020
• Study Start: November 24, 2020
• Primary Completion: December 16, 2022
• Study Completion: May 12, 2023
• Last Updated: May 17, 2023

Record last verified: 2023-05

Locations

DE (1)