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Completed

NCT Number: NCT04538794

A Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria

This is a study to determine the safety of multiple doses of CDX-0159 in patients with Chronic Spontaneous Urticaria.

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Key information

Conditions

Chronic Spontaneous Urticaria Chronic Disease Chronic Urticaria Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Charite University, Berlin, Germany

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About this study

The purpose of the study is to explore the safety, pharmacodynamics, and pharmacokinetics of ascending doses of CDX-0159 in patients with Chronic Spontaneous Urticaria who remain symptomatic despite treatment with antihistamines.

There is a screening period of up to 2 weeks, a 12-week double-blind treatment period and a 12-week follow-up period after treatment. Patients will receive multiple doses of CDX-0159 or placebo as add on therapy to their antihistamine.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Males and females, 18 - 75 years old.
  • Diagnosis of chronic spontaneous urticaria (CSU) despite the use of H1-antihistamines alone or in combination with H2-antihistamines and/or leukotriene receptor antagonists, as defined by:
  • Diagnosis of CSU for >/= 6 months.
  • The presence of itch and hives for >/= 6 consecutive weeks at any time prior to Visit 1 despite current use of H1-antihistamines.
  • UAS7 of >/= 16 and HSS7 of >/= 8 during the 7 days before treatment
  • In-clinic UAS >/= 4 on one of the screening visit days
  • Use of H1-antihistamines alone or in combination with H2-antihistamines and/or leukotriene receptor antagonists for at least 3 days immediately prior to study entry and throughout the study.
  • Other than CSU, have no other significant medical conditions that would cause additional risk or interfere with study procedures.
  • Normal blood counts and liver function tests.
  • Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days afterwards after treatment.
  • Willing and able to complete a daily symptom electronic diary for the duration of the study and adhere to the study visit schedule.

Key Exclusion Criteria:

  • Women who are pregnant or nursing.
  • Cleary defined cause for chronic urticaria.
  • Known HIV, hepatitis B or hepatitis C infection.
  • Vaccination with a live vaccine within 4 weeks prior to study drug administration (subjects must agree to avoid vaccination during the study). Inactivated vaccines are allowed such as seasonal influenza for injection.
  • History of anaphylaxis.

There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.

Treatment and study plan

CDX-0159

Drug

Administered intravenously

normal saline

Drug

Administered intravenously

Primary outcomes

  1. Safety as assessed by the incidence and severity of adverse events

    Time frame: From Day 1 (first dose) to Day 169 (last follow-up visit)

    Safety of multiple, ascending doses of CDX-0159 as determined by drug related adverse events

Secondary outcomes

  1. Pharmacokinetic evaluation

    Time frame: From Day 1 (before first dose) to Day 169 (last follow-up visit)

    CDX-0159 serum concentrations will be measured at specified visits

  2. Pharmacodynamic evaluation

    Time frame: From Day 1 (first dose) to Day 169 (last follow-up visit)

    The change from baseline for Urticaria Activity Score (UAS7) in patients who received CDX-0159 vs. placebo

  3. Pharmacodynamic evaluation

    Time frame: From Day 1 (first dose) to Day 169 (last follow-up visit)

    The change from baseline for Hives Severity Score (HSS7) in patients who received CDX-0159 vs. placebo

  4. Pharmacodynamic evaluation

    Time frame: From Day 1 (first dose) to Day 169 (last follow-up visit)

    The change from baseline for Itch Severity Score (ISS7) in patients who received CDX-0159 vs. placebo

  5. Pharmacodynamic evaluation

    Time frame: Day 1 (first dose) to Day 169 (last follow up visit)

    The change in baseline for Urticaria Control Test (UCT) in patients who received CDX-0159 vs. placebo

  6. Pharmacodynamic evaluation

    Time frame: From Day 1 (before first dose) to Day 169 (last follow-up visit)

    The effect of CDX-0159 on stem cell factor levels

  7. Pharmacodynamic evaluation

    Time frame: From Day 1 (before first dose) to Day 169 (last follow-up visit)

    The effect of CDX-0159 on tryptase

  8. Safety evaluation

    Time frame: From Day 1 (before dosing) to Day 169 (last follow-up visit)

    Assessment of immunogenicity by measuring the development of anti- CDX-0159 antibodies

Sponsors and collaborators

Lead sponsor

Celldex Therapeutics

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of CDX-0159 as Add-on Therapy in Patients With Chronic Spontaneous Urticaria

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Sep 4, 2020
Registry last updated
Jul 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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