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

Phase 1

Completed

• Conditions: Chronic Spontaneous Urticaria
• Interventions: Drug: Normal Saline; Drug: CDX-0159

• Registration Number: NCT04538794
• Lead Sponsor: Celldex Therapeutics

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2020-08-31
• Study First Submitted QC: 2020-08-31
• Study First Posted: 2020-09-04
• Study Start: 2020-09-24
• Primary Completion: 2023-01-17
• Study Completion: 2023-01-17
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-17
• Last Update Posted: 2023-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Saline	Normal Saline	Normal saline every 4-8 weeks
CDX-0159	CDX-0159	CDX-0159 every 4-8 weeks

Primary Outcome Measures

Name	Time	Method
Safety as assessed by the incidence and severity of adverse events	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 Outcome Measures

Name	Time	Method
Pharmacokinetic evaluation	From Day 1 (before first dose) to Day 169 (last follow-up visit)	CDX-0159 serum concentrations will be measured at specified visits
Pharmacodynamic evaluation	From Day 1 (before first dose) to Day 169 (last follow-up visit)	The effect of CDX-0159 on tryptase
Safety evaluation	From Day 1 (before dosing) to Day 169 (last follow-up visit)	Assessment of immunogenicity by measuring the development of anti- CDX-0159 antibodies

Trial Locations

Locations (14)

ForCare Clinical Research; 🇺🇸 Tampa, Florida, United States

Dawes Fretzin Clinical Research; 🇺🇸 Indianapolis, Indiana, United States

Arizona Allergy & Immunology Research; 🇺🇸 Gilbert, Arizona, United States

Treasure Valley Medical Research; 🇺🇸 Boise, Idaho, United States

Sarasota Clinical Research; 🇺🇸 Sarasota, Florida, United States

Midwest Allergy, Sinus and Asthma, SC; 🇺🇸 Normal, Illinois, United States

Kanarek Allergy Asthma & Immunology; 🇺🇸 Overland Park, Kansas, United States

Bernstein Clinical Research Center, LLC; 🇺🇸 Cincinnati, Ohio, United States

Asthma, Nasal Disease & Allergy Research Center of New England; 🇺🇸 East Providence, Rhode Island, United States

National Allergy and Asthma Research, LLC; 🇺🇸 North Charleston, South Carolina, United States

Charite University; 🇩🇪 Berlin, Germany

Vital Prospects Clinical Research Institute, PC; 🇺🇸 Tulsa, Oklahoma, United States

AARA Research; 🇺🇸 Dallas, Texas, United States

Clinical Research Center of Alabama; 🇺🇸 Birmingham, Alabama, United States