Clinical trial NCT06366750: A Study of Barzolvolimab in Patients With Prurigo Nodularis
Official title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab (CDX-0159) in Patients With Prurigo Nodularis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Prurigo Nodularis
Keywords: barzolvolimab
PN
CDX-0159
Lead sponsor: Celldex Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-04-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy and safety of barzolvolimab in adults with prurigo nodularis.

Detailed description: The purpose of this study is to assess the efficacy and safety of barzolvolimab (CDX-0159) in adults with prurigo nodularis.

There is a screening period of approximately 28 days, a 24-week double-blind treatment period and a 16-week follow-up period after treatment. Participants will be randomly assigned on a 1:1:1 ratio to receive barzolvolimab (CDX-0159) by subcutaneous injections of 150 mg every 4 weeks (Q4W) after an initial loading dose of 450 mg, 300 mg Q4W after an initial loading dose of 450 mg, or placebo Q4W.

Eligibility criteria: Key Inclusion Criteria:

1. Males and females, ≥18 years of age.
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 for stage of chronic nodular prurigo (IGA-CNPG-S) 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) once or twice a day 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 PN lesions limited to small area on one side of the body (e.g., only one arm affected).
3. Active unstable pruritic skin conditions in addition to PN.
4. Documented atopic dermatitis (moderate to severe) within 6 months before the start of screening.
5. Females who are pregnant or nursing.
6. Known hepatitis B or hepatitis C infection or active COVID-19 infection.
7. 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.
8. History of anaphylaxis.
9. Prior receipt of barzolvolimab

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

Primary outcomes:
measure: Proportion of participants with improvement in Worst Itch Numeric Rating Scale (WI-NRS) by ≥ 4 from baseline to Week 12.
timeFrame: From Day 1 (first dose) to Day 85 (week 12)
Secondary outcomes:
measure: Proportion of participants with improvement in WI-NRS by ≥ 4 from baseline to Week 4.
timeFrame: From Day 1 (first dose) to Week 4
measure: Proportion of participants with improvement in WI-NRS by ≥ 4 from baseline to Week 24.
timeFrame: From Day 1 (first dose) to Week 24
measure: Proportion of participants with improvement in WI-NRS by ≥ 4 from baseline to Day 169 (week 24).
timeFrame: From Day 1 (first dose) to Day 169 (week 24)
measure: Proportion of participants with Investigator Global Assessment for stage of chronic nodular prurigo score (IGA-CNPG-S) of 0 or 1 at Weeks 4, 12 and 24.
timeFrame: From Day 1 (first dose) to Day 169 (week 24)
measure: Proportion of participants with improvement in both WI-NRS by ≥ 4 from baseline and IGA-CNPG-S score of 0 or 1 at Weeks 4, 12 and 24.
timeFrame: From Day 1 (first dose) to Day 169 (week 24)
measure: Proportion of participants with Investigator Global Assessment for activity of chronic prurigo (IGA-CPG-A) score of 0 or 1 at Weeks 4, 12 and 24.
timeFrame: From Day 1 (first dose) to Day 169 (week 24)
measure: Absolute change from baseline in WI-NRS at Weeks 4, 12 and 24.
timeFrame: From Day 1 (first dose) to Day 169 (week 24)
measure: Percentage change from baseline in WI-NRS at Weeks 4, 12 and 24.
timeFrame: From Day 1 (first dose) to Day 169 (week 24)
measure: Absolute change from baseline in Sleep Quality Numerical Rating Scale (SQ-NRS) at Weeks 4, 12 and 24.
timeFrame: From Day 1 (first dose) to Day 169 (week 24)
measure: Percentage change from baseline in SQ-NRS at Weeks 4, 12 and 24.
timeFrame: From Day 1 (first dose) to Day 169 (week 24)
measure: Absolute change from baseline in Worst Pain Numerical Rating Scale (WP-NRS) at Weeks 4, 12 and 24.
timeFrame: From Day 1 (first dose) to Day 169 (week 24)
measure: Percentage change from baseline in WP-NRS at Weeks 4, 12 and 24.
timeFrame: From Day 1 (first dose) to Day 169 (week 24)
measure: Absolute change from baseline in Patient-Reported Outcomes Measurement Information System Fatigue - Short Form 7b Daily (PROMIS Fatigue-SF Daily) at Weeks 4, 12 and 24.
timeFrame: From Day 1 (first dose) to Day 169 (week 24)
measure: Percentage change from baseline in PROMIS Fatigue-SF Daily at Weeks 4, 12 and 24.
timeFrame: From Day 1 (first dose) to Day 169 (week 24)
measure: Absolute change from baseline in Dermatology Life Quality Index (DLQI) at Weeks 4, 12 and 24.
timeFrame: From Day 1 (first dose) to Day 169 (week 24)
measure: Percentage change from baseline in Dermatology Life Quality Index (DLQI) at Weeks 4, 12 and 24.
timeFrame: From Day 1 (first dose) to Day 169 (week 24)
measure: Proportion of participants with WI-NRS score < 2 at Weeks 4, 12 and 24.
timeFrame: From Day 1 (first dose) to Day 169 (week 24)
measure: Proportion of participants with improvement in SQ-NRS by ≥ 4 from baseline to Week 4, 12 and 24.
timeFrame: From Day 1 (first dose) to Day 169 (week 24)
measure: Proportion of participants with improvement in WP-NRS by ≥ 4 from baseline to Weeks 4, 12 and 24.
timeFrame: From Day 1 (first dose) to Day 169 (week 24)
measure: Proportion of participants with improvement of ≥ 4 in DLQI from baseline to Weeks 4, 12 and 24.
timeFrame: From Day 1 (first dose) to Day 169 (week 24)
measure: Proportion of participants achieving DLQI score of 0 or 1 at Weeks 4, 12 and 24.
timeFrame: From Day 1 (first dose) to Day 169 (week 24)
measure: Absolute change from baseline in PGIS, PGIS-SD, PGIC and PGIC-SD.
timeFrame: From Day 1 (first dose) to Day 169 (week 24)
measure: Percentage change from baseline in PGIS, PGIS-SD, PGIC and PGIC-SD at Weeks 4, 12 and 24.
timeFrame: From Day 1 (first dose) to Day 169 (week 24)
measure: Number of participants with Treatment-Emergent Adverse Events (TEAEs) throughout the study.
timeFrame: From Day 1 (first dose) to Day 281 (last follow-up visit)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Dermatology
state: Alabama
city: Scottsdale
country: United States
facility: Investigate MD, LLC
state: Arizona
city: Scottsdale
country: United States
facility: Scottsdale Clinical Trials
state: Arizona
city: Rogers
country: United States
facility: Northwest Arkansas Clinical Trials Center
state: Arkansas
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research, Inc
state: California
city: Oceanside
country: United States
facility: Profound Research LLC
state: California
city: Pomona
country: United States
facility: Empire Clinical Research
state: California
city: Santa Monica
country: United States
facility: Dermatology Institute & Skin Care Center
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Tampa
country: United States
facility: Advanced Clinical Research Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Columbus
country: United States
facility: Centricity Research
state: Georgia
city: Boise
country: United States
facility: Treasure Valley Medical Research
state: Idaho
city: Chicago
country: United States
facility: MetroMed Clinical Trials
state: Illinois
city: Clarksville
country: United States
facility: DS Research of Southern Indiana, LLC
state: Indiana
city: Louisville
country: United States
facility: DS Research of Kentucky, LLC
state: Kentucky
city: Quincy
country: United States
facility: Beacon Clinical Research, LLC
state: Massachusetts
city: Troy
country: United States
facility: Revival Research Institute, LLC
state: Michigan
city: Saint Joseph
country: United States
facility: Medisearch, LLC
state: Missouri
city: Omaha
country: United States
facility: Skin Specialists PC
state: Nebraska
city: Albuquerque
country: United States
facility: University of New Mexico Department of Dermatology
state: New Mexico
city: Cincinnati
country: United States
facility: UC Health Physicians Office Dermatology
state: Ohio
city: Philadelphia
country: United States
facility: Paddington Testing, PO
state: Pennsylvania
city: Columbia
country: United States
facility: Columbia Dermatology and Aesthetics
state: South Carolina
city: Webster
country: United States
facility: Center for Clinical Studies
state: Texas
city: Morgantown
country: United States
facility: West Virginia Research Institute
state: West Virginia
city: Edmonton
country: Canada
facility: Stratica Dermatology
state: Alberta
city: Barrie
country: Canada
facility: SimcoDerm Medical and Surgical Dermatology Center
state: Ontario
city: Etobicoke
country: Canada
facility: Kingsway Clinical Research
state: Ontario
city: Guelph
country: Canada
facility: Guelph Dermatology Research
state: Ontario
city: London
country: Canada
facility: Derm Effects
state: Ontario
city: Toronto
country: Canada
facility: North York Research Inc
state: Ontario
city: Toronto
country: Canada
facility: Toronto Research Centre
state: Ontario
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim, Klinisches Studienzentrum
city: Berlin
country: Germany
facility: Institut für Allergieforschung (IFA),Charité - Universitätsmedizin Berlin
city: Bochum
country: Germany
facility: Katholisches Klinikum Bochum
city: Frankfurt
country: Germany
facility: Universitätsklinikum RWTH Aachen- Dermatology
city: Frankfurt
country: Germany
facility: Universtätsklinikum Frankfurt, Klinik für Dermatologie, Venerologie und
city: Münster
country: Germany
facility: Universitätsklinikum Münster (UKM)
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen - Hautklinik
city: Kraków
country: Poland
facility: Centrum Nowoczesnych Terapii "Dobry Lekarz"
state: Małopolska
city: Katowice
country: Poland
facility: Gyncentrum sp. z o.o.
city: Kraków
country: Poland
facility: Pratia MCM Krakόw
city: Lublin
country: Poland
facility: LUXDERM Specjalistyczny Gabinet
city: Rzeszów
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie
city: Warsaw
country: Poland
facility: Clinical /research group Z.o.o.
city: Warszawa
country: Poland
facility: Klinika Ambroziak Dermatologia
city: Wroclaw
country: Poland
facility: DERMACEUM Centrum Badan
city: A Coruña
country: Spain
facility: Complexo Hospitalario Universitario de Santiago de Compostela
city: Alicante
country: Spain
facility: Hospital General Universitario Dr Balmis, ISABIAL
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre, Madrid
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
Study officials:
References: