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

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Spontaneous Urticaria
• Intervention / Treatment: Drug: CDX-0159; Drug: Normal Saline

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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Charité university
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Clinical Research Center of Alabama
  • Arizona
    • Gilbert, Arizona, United States, 85234
      • Arizona Allergy & Immunology Research
  • Florida
    • Sarasota, Florida, United States, 34239
      • Sarasota Clinical Research
    • Tampa, Florida, United States, 33613
      • ForCare Clinical Research
  • Idaho
    • Boise, Idaho, United States, 83706
      • Treasure Valley Medical Research
  • Illinois
    • Normal, Illinois, United States, 61761
      • Midwest Allergy, Sinus and Asthma, SC
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Dawes Fretzin Clinical Research
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Kanarek Allergy Asthma & Immunology
  • Ohio
    • Cincinnati, Ohio, United States, 45231
      • Bernstein Clinical Research Center, LLC
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136-7028
      • Vital Prospects Clinical Research Institute, PC
  • Rhode Island
    • East Providence, Rhode Island, United States, 02914
      • Asthma, Nasal Disease & Allergy Research Center of New England
  • South Carolina
    • North Charleston, South Carolina, United States, 29420
      • National Allergy and Asthma Research, LLC
  • Texas
    • Dallas, Texas, United States, 75231
      • AARA Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CDX-0159; CDX-0159 every 4-8 weeks	Drug: CDX-0159; Administered intravenously
Placebo Comparator: Normal Saline; Normal saline every 4-8 weeks	Drug: Normal Saline; Administered intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
Pharmacodynamic evaluation	The effect of CDX-0159 on tryptase	From Day 1 (before first dose) to Day 169 (last follow-up visit)
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)

Collaborators and Investigators

• Sponsor: Celldex Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2020
• Primary Completion (Actual): January 17, 2023
• Study Completion (Actual): January 17, 2023

Study Registration Dates

• First Submitted: August 31, 2020
• First Submitted That Met QC Criteria: August 31, 2020
• First Posted (Actual): September 4, 2020

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 17, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: CDX-0159
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Disease Attributes; Skin Diseases, Vascular; Hypersensitivity; Chronic Disease; Urticaria; Chronic Urticaria
• Other Study ID Numbers: CDX0159-02; 2020-005426-29 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No