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

July 17, 2023 updated by: Celldex Therapeutics

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Charite 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
From Day 1 (first dose) to Day 169 (last follow-up visit)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
From Day 1 (before first dose) to Day 169 (last follow-up visit)
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
From Day 1 (first dose) to Day 169 (last follow-up visit)
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
From Day 1 (first dose) to Day 169 (last follow-up visit)
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
From Day 1 (first dose) to Day 169 (last follow-up visit)
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
Day 1 (first dose) to Day 169 (last follow up visit)
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
From Day 1 (before first dose) to Day 169 (last follow-up visit)
Pharmacodynamic evaluation
Time Frame: From Day 1 (before first dose) to Day 169 (last follow-up visit)
The effect of CDX-0159 on tryptase
From Day 1 (before first dose) to Day 169 (last follow-up visit)
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
From Day 1 (before dosing) to Day 169 (last follow-up visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Celldex Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 24, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 17, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 17, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 31, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 4, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 19, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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