Clinical trial NCT04944862: A Study of CDX-0159 in Patients With Prurigo Nodularis
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Single Dose Study to Assess the Safety, Pharmacokinetics, and Clinical Effect of CDX-0159 in Patients With Prurigo Nodularis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prurigo Nodularis
Keywords: CDX-0159
barzolvolimab
Lead sponsor: Celldex Therapeutics
Sponsor class: INDUSTRY
First posted: 2021-06-30
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to explore the safety, clinical effect, pharmacodynamics, and pharmacokinetics of CDX-0159 (barzolvolimab) in patients with Prurigo Nodularis.

Detailed description: The purpose of the study is to explore the safety, clinical effect, pharmacodynamics, and pharmacokinetics of CDX-0159 (barzolvolimab) in patients with Prurigo Nodularis.

There is a screening period of up to 2 weeks, an 8-week double-blind treatment period and a 16-week follow-up period after treatment. Patients will receive one dose of CDX-0159 (barzolvolimab) or placebo.

Eligibility criteria: Key Inclusion Criteria:

1. Males and females, 18 - 75 years old.
2. Diagnosis of Prurigo Nodularis by a dermatologist at least 3 months prior to Screening with:

   1. At least 20 PN nodules with bilateral distribution on both arms and/or both legs and/or both sides of the trunk at screening.
   2. An Investigators Global Assessment (IGA) score for PN ≥ 3 at screening and Baseline (Day 1).
3. Severe itch, defined as the mean of the daily worst itch NRS (WI-NRS) score of ≥ 7 during the 7-day period immediately prior to initiation of study treatment.
4. Documented history of inadequate response to prescription topical medications or for whom topical medications are medically inadvisable.
5. Willing to apply a topical moisturizer (emollient) twice daily throughout the study.
6. 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.
7. 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. PN due to neuropathy, psychiatric disorders or medications.
2. Unilateral lesions of prurigo (eg, only one arm affected)
3. Active unstable pruritic skin conditions in addition to PN.
4. Women who are pregnant or nursing.
5. Known hepatitis B or hepatitis C infection or active COVID-19 infection
6. Vaccination with a live vaccine within 2 months prior to study drug administration (subjects must agree to avoid vaccination during the study and for four months thereafter). NOTE: Inactivated vaccines are allowed such as seasonal influenza for injection. COVID-19 vaccination is allowed.
7. History of anaphylaxis.

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

Primary outcomes:
measure: Safety and tolerability as assessed by the incidence and severity of adverse events
timeFrame: From Day 1 (first dose) to Day 169 (last follow-up visit)
Secondary outcomes:
measure: Pharmacokinetic evaluation
timeFrame: From Day 1 (before first dose) to Day 169 (last follow-up visit)
measure: Clinical effect of CDX-0159 on pruritus
timeFrame: From Day 1 (first dose) to Day 57 (week 8)
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Desert Sky Dermatology
state: Arizona
city: Miami
country: United States
facility: University of Miami, Dermatology Clinical Trials Unit
state: Florida
city: Troy
country: United States
facility: Revival Research Institute, LLC
state: Michigan
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: New York
country: United States
facility: Markowitz Medical/Optiskin
state: New York
city: Norman
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Houston
country: United States
facility: Center for Clinical Studies, LTD.LLP
state: Texas
city: Berlin
country: Germany
facility: Charité Centrum für Innere Medizin und Dermatologie, Institute of Allergology (IFA)
city: Bochum
country: Germany
facility: Katholisches Klinikum Bochum gGmbH, Dermatologische Studienambulanz
city: Dresden
country: Germany
facility: Universitatsklinikum Carl Gustav Carus Dresden, Klinik und Poliklinik fur Dermatologie
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt Klinik für Dermatologie, Venerologie und Allergologie Klinische Forschung
city: Mainz
country: Germany
facility: Universitätsklinikum Erlangen Hautklinik
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz Hautklinik, Clinical Research Center
city: Münster
country: Germany
facility: Universitaetsklinikum Muenster (UKM) - Klinik für Hautkrankheiten
city: Krosno
country: Poland
facility: MT Medic Specjalistyczna Praktyka Lekarska
city: Wrocław
country: Poland
facility: Centrum Medyczne Ginemedica
city: Łódź
country: Poland
facility: IP Clinic Sp. z o.o.
Study officials:
References: