Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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.
Phase
Phase 1
Funding Agency/Sponsor
Industry
Disease
Other
Enrollment Eligibility
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.