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

Chronic Spontaneous Urticaria Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04538794
• Other study ID #: CDX0159-02
• Secondary ID: 2020-005426-29
• Status: Completed
• Phase: Phase 1
• Start date: September 24, 2020
• Est. completion date: January 17, 2023

Study information

• Verified date: July 2023
• Source: Celldex Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: January 17, 2023
• Est. primary completion date: January 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Key Inclusion Criteria:

1. Males and females, 18 - 75 years old.

2. 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:

1. Diagnosis of CSU for >/= 6 months.

2. The presence of itch and hives for >/= 6 consecutive weeks at any time prior to Visit 1 despite current use of H1-antihistamines.

3. UAS7 of >/= 16 and HSS7 of >/= 8 during the 7 days before treatment

4. In-clinic UAS >/= 4 on one of the screening visit days

5. 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.

3. Other than CSU, have no other significant medical conditions that would cause additional risk or interfere with study procedures.

4. Normal blood counts and liver function tests.

5. 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.

6. 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:

1. Women who are pregnant or nursing.

2. Cleary defined cause for chronic urticaria.

3. Known HIV, hepatitis B or hepatitis C infection.

4. 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.

5. History of anaphylaxis.

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

Related Conditions & MeSH terms

• Chronic Spontaneous Urticaria
• Chronic Urticaria
• Urticaria

Intervention

Drug:
• CDX-0159
Administered intravenously
• Normal Saline
Administered intravenously

Locations

Country	Name	City	State
Germany	Charite University	Berlin
United States	Clinical Research Center of Alabama	Birmingham	Alabama
United States	Treasure Valley Medical Research	Boise	Idaho
United States	Bernstein Clinical Research Center, LLC	Cincinnati	Ohio
United States	AARA Research	Dallas	Texas
United States	Asthma, Nasal Disease & Allergy Research Center of New England	East Providence	Rhode Island
United States	Arizona Allergy & Immunology Research	Gilbert	Arizona
United States	Dawes Fretzin Clinical Research	Indianapolis	Indiana
United States	Midwest Allergy, Sinus and Asthma, SC	Normal	Illinois
United States	National Allergy and Asthma Research, LLC	North Charleston	South Carolina
United States	Kanarek Allergy Asthma & Immunology	Overland Park	Kansas
United States	Sarasota Clinical Research	Sarasota	Florida
United States	ForCare Clinical Research	Tampa	Florida
United States	Vital Prospects Clinical Research Institute, PC	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Celldex Therapeutics

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety as assessed by the incidence and severity of adverse events	Safety of multiple, ascending doses of CDX-0159 as determined by drug related adverse events	From Day 1 (first dose) to Day 169 (last follow-up visit)
Secondary	Pharmacokinetic evaluation	CDX-0159 serum concentrations will be measured at specified visits	From Day 1 (before first dose) to Day 169 (last follow-up visit)
Secondary	Pharmacodynamic evaluation	The change from baseline for Urticaria Activity Score (UAS7) in patients who received CDX-0159 vs. placebo	From Day 1 (first dose) to Day 169 (last follow-up visit)
Secondary	Pharmacodynamic evaluation	The change from baseline for Hives Severity Score (HSS7) in patients who received CDX-0159 vs. placebo	From Day 1 (first dose) to Day 169 (last follow-up visit)
Secondary	Pharmacodynamic evaluation	The change from baseline for Itch Severity Score (ISS7) in patients who received CDX-0159 vs. placebo	From Day 1 (first dose) to Day 169 (last follow-up visit)
Secondary	Pharmacodynamic evaluation	The change in baseline for Urticaria Control Test (UCT) in patients who received CDX-0159 vs. placebo	Day 1 (first dose) to Day 169 (last follow up visit)
Secondary	Pharmacodynamic evaluation	The effect of CDX-0159 on stem cell factor levels	From Day 1 (before first dose) to Day 169 (last follow-up visit)
Secondary	Pharmacodynamic evaluation	The effect of CDX-0159 on tryptase	From Day 1 (before first dose) to Day 169 (last follow-up visit)
Secondary	Safety evaluation	Assessment of immunogenicity by measuring the development of anti- CDX-0159 antibodies	From Day 1 (before dosing) to Day 169 (last follow-up visit)