Prurigo NodularisPhase 2NCT06366750
A Study of Barzolvolimab in Patients With Prurigo Nodularis
A Phase 2 study testing barzolvolimab in people with Prurigo Nodularis, run by Celldex Therapeutics at 72 sites in 6 countries.
Trial summary
The purpose of this study is to assess the efficacy and safety of barzolvolimab in adults with prurigo nodularis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prurigo Nodularis
- What is being tested?
- barzolvolimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 72 sitesin 6 countries
- Study dates
- 12 Apr 2024to Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females, ≥18 years of age.
- Diagnosis of Prurigo Nodularis by a dermatologist at least 3 months prior to Screening with:
- At least 20 PN nodules with bilateral distribution on both arms and/or both legs and/or both sides of the trunk at screening.
- An Investigators Global Assessment for stage of chronic nodular prurigo (IGA-CNPG-S) score for PN ≥ 3 at screening and Baseline (Day 1).
- 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.
- Documented history of inadequate response to prescription topical medications or for whom topical medications are medically inadvisable.
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- Willing to apply a topical moisturizer (emollient) once or twice a day throughout the study.
- 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.
- Willing and able to complete a daily symptom electronic diary for the duration of the study and adhere to the study visit schedule.
Who cannot join
- PN due to neuropathy, psychiatric disorders or medications.
- Unilateral PN lesions limited to small area on one side of the body (e.g., only one arm affected).
- Active unstable pruritic skin conditions in addition to PN.
- Documented atopic dermatitis (moderate to severe) within 6 months before the start of screening.
- Females who are pregnant or nursing.
- Known hepatitis B or hepatitis C infection or active COVID-19 infection.
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- 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.
- History of anaphylaxis.
- Prior receipt of barzolvolimab
- There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
Trial locations and contacts
72 sites in 6 countries.
72 sites in 6 countries
United States37 sites
University of New Mexico Department of Dermatology
Albuquerque, New Mexico, 87102
Emory University
Atlanta, Georgia, 30322
Total Dermatology
Birmingham, Alabama, 35203
Cahaba Dermatology Skin Health Center
Birmingham, Alabama, 35244
Treasure Valley Medical Research
Boise, Idaho, 83706
Equity Medical
Bowling Green, Kentucky, 42104
Encore Medical Research Boynton Beach
Boynton Beach, Florida, 33436
Apex Clinical Research Center - Canton
Canton, Ohio, 44718
MetroMed Clinical Trials
Chicago, Illinois, 60614
UC Health Physicians Office Dermatology
Cincinnati, Ohio, 45219
DS Research of Southern Indiana, LLC
Clarksville, Indiana, 47129
Columbia Dermatology and Aesthetics
Columbia, South Carolina, 29212
Centricity Research
Columbus, Georgia, 31904
Dermatology Treatment and Research Center
Dallas, Texas, 75230
Center for Dermatology Clinical Research, Inc
Fremont, California, 94538
Biobrilliance Medical Research Center
Hialeah, Florida, 33106
Encore Medical Research
Hollywood, Florida, 33024
DS Research of Kentucky, LLC
Louisville, Kentucky, 40241
Life Arc Research Centers Corp
Miami, Florida, 33126
University of Miami
Miami, Florida, 33134
International Clinical Research - Tennessee LLC
Murfreesboro, Tennessee, 37130
Equity Medical
New York, New York, 10023
Profound Research LLC
Oceanside, California, 92056
Skin Specialists PC
Omaha, Nebraska, 68144
Paddington Testing, PO
Philadelphia, Pennsylvania, 01913
Empire Clinical Research
Pomona, California, 91767
Medisearch, LLC
Saint Joseph, Missouri, 64506
University of California San Francisco
San Francisco, California, 94115
University of California, San Francisco
San Francisco, California, 94115
Dermatology Institute & Skin Care Center
Santa Monica, California, 90404
Investigate MD, LLC
Scottsdale, Arizona, 85255
Scottsdale Clinical Trials
Scottsdale, Arizona, 85260
Advanced Clinical Research Institute
Tampa, Florida, 33607
Revival Research Institute, LLC
Troy, Michigan, 48084
Center for Clinical Studies
Webster, Texas, 77598
Focus Clinical Research
West Hills, California, 91307
Encore Medical Research of Weston
Weston, Florida, 33331
Poland11 sites
FutureMeds Gdynia
Gdynia
Centrum Medyczne Pratia Katowice
Katowice
Gyncentrum sp. z o.o.
Katowice
Centrum Nowoczesnych Terapii "Dobry Lekarz"
Krakow, Małopolska
Pratia MCM Krakόw
Krakow
LUXDERM Specjalistyczny Gabinet
Lublin
Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie
Rzeszów
Clinical /research group Z.o.o.
Warsaw
Gyncentrum sp. z o.o., NZOZ Gyncentrum - Oddział Warszawa
Warsaw
Klinika Ambroziak Dermatologia
Warsaw
DERMACEUM Centrum Badan
Wroclaw
Germany10 sites
Universitätsklinikum Augsburg
Augsburg
Fachklinik Bad Bentheim, Klinisches Studienzentrum
Bad Bentheim
Institut für Allergieforschung (IFA),Charité - Universitätsmedizin Berlin
Berlin
Katholisches Klinikum Bochum
Bochum
Universitätsklinikum Erlangen - Hautklinik
Erlangen
Universitätsklinikum RWTH Aachen- Dermatology
Frankfurt, 52074
Universtätsklinikum Frankfurt, Klinik für Dermatologie, Venerologie und
Frankfurt
University Hospital Heidelberg
Heidelberg
Universitätsklinikum Münster (UKM)
Münster
Universitätsklinikum Tübingen - Hautklinik
Tübingen
Canada6 sites
SimcoDerm Medical and Surgical Dermatology Center
Barrie, Ontario
Stratica Dermatology
Edmonton, Alberta
Kingsway Clinical Research
Etobicoke, Ontario
Guelph Dermatology Research
Guelph, Ontario
Derm Effects
London, Ontario
North York Research Inc
Toronto, Ontario
Spain5 sites
Complexo Hospitalario Universitario de Santiago de Compostela
A Coruña
Hospital General Universitario Dr Balmis, ISABIAL
Alicante
Hospital de la Santa Creu i Sant Pau
Barcelona
FutureMeds - Madrid
Madrid
FutureMeds - Sevilla
Seville
Croatia3 sites
Special Hospital Medico
Rijeka
University Hospital Center - Rijeka
Rijeka
Solmed Clinic
Zagreb
About this study
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
The purpose of this study is to assess the efficacy and safety of barzolvolimab in adults with prurigo nodularis.
Read the 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.
Following the completion of the treatment period, participants may enter an open label extension portion of the study if they are eligible.
- Conditions
- Prurigo Nodularis
- Being tested
- barzolvolimab, Matching Placebo
- Keywords
- barzolvolimab, PN, CDX-0159
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
barzolvolimabBiological
subcutaneous administration
Matching PlaceboOther
subcutaneous administration
| Study group | Role | What they receive |
|---|---|---|
| Barzolvolimab 450 mg, then 150 mg Q4W | Experimental | 450 mg subcutaneous administration loading dose on Day 1 followed by 150 mg subcutaneous administration every 4 weeks, starting on Week 4, to Week 24. Receives: Biological: barzolvolimab |
| Barzolvolimab 450 mg, then 300 mg Q4W | Experimental | 450 mg subcutaneous administration loading dose on Day 1 followed by 300 mg subcutaneous administration every 4 weeks, starting on Week 4, to Week 24. Receives: Biological: barzolvolimab |
| Placebo | Placebo comparator | Matching placebo subcutaneous administration every 4 weeks, starting on Week 4, to Week 24. Receives: Other: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with improvement in Worst Itch Numeric Rating Scale (WI-NRS) by ≥ 4 from baseline to Week 12.
WI-NRS is a validated measure of itch severity. Participants are asked daily to rate the intensity of their worst pruritis (itch) over the past 24 hours using an 11-point scale ranging from 0= no itch to 10= worst imaginable itch. Higher scores indicate more severity.
Measured: From Day 1 (first dose) to Day 85 (week 12)
Secondary outcomes (24)
Proportion of participants with improvement in WI-NRS by ≥ 4 from baseline to Week 4.
WI-NRS is a validated measure of itch severity. Participants are asked daily to rate the intensity of their worst pruritis (itch) over the past 24 hours using an 11-point scale ranging from 0= no itch to 10= worst imaginable itch. Higher scores indicate more severity.
Measured: From Day 1 (first dose) to Week 4
Proportion of participants with improvement in WI-NRS by ≥ 4 from baseline to Week 24.
WI-NRS is a validated measure of itch severity. Participants are asked daily to rate the intensity of their worst pruritis (itch) over the past 24 hours using an 11-point scale ranging from 0= no itch to 10= worst imaginable itch. Higher scores indicate more severity.
Measured: From Day 1 (first dose) to Week 24
Proportion of participants with improvement in WI-NRS by ≥ 4 from baseline to Day 169 (week 24).
WI-NRS is a validated measure of itch severity. Participants are asked daily to rate the intensity of their worst pruritis (itch) over the past 24 hours using an 11-point scale ranging from 0= no itch to 10= worst imaginable itch. Higher scores indicate more severity.
Measured: From Day 1 (first dose) to Day 169 (week 24)
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.
The IGA-CNPG-S is an instrument used to assess the overall number of PN lesions at a given timepoint, as determined by the investigator. It consists of a 5-point scale ranging from 0 to 4 where 0= clear, 1= almost clear, 2= mild, 3= moderate, and 4= severe. Higher scores indicate severe PN. In this outcome measure, percentage of participants with an IGA-CNPG-S score of either 0 or 1 at Weeks 4, 12 and 24 will be reported.
Measured: From Day 1 (first dose) to Day 169 (week 24)
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.
WI-NRS is a validated measure of itch severity. Participants are asked daily to rate the intensity of their worst pruritis (itch) over the past 24 hours using an 11-point scale ranging from 0 = no itch to 10 =worst imaginable itch. Higher scores indicate more severity.
The Investigator Global Assessment for stage of chronic nodular prurigo (IGA-CNPG-S) is an instrument used to assess the overall number of PN lesions at a given timepoint, as determined by the investigator. It consists of a 5-point scale ranging from 0 to 4 where 0= clear, 1= almost clear, 2= mild, 3= moderate, and 4= severe. Higher scores indicate severe PN.
Percentage of participants who achieve both an improvement in WI-NRS and an improvement in IGA-CNPG-S will be reported in this outcome.
Measured: From Day 1 (first dose) to Day 169 (week 24)
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.
The IGA-CPG-A is an instrument used to assess the overall activity of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0-4 where 0= clear (0% lesions showing excoriations/crusts), 1= almost clear (1-10% lesions showing excoriations/crusts), 2= Mild (11-25% lesions showing excoriations/crusts), 3= moderate (26-75% lesions showing excoriations/crusts), 4= severe (76-100% lesions showing excoriations/crusts). Higher scores indicate severe PN. In this outcome measure, percentage of participants with an IGA-CPG-A score of either 0 (clear) or 1 (almost clear) at Weeks 4,12 and 24 will be reported.
Measured: From Day 1 (first dose) to Day 169 (week 24)
Absolute change from baseline in WI-NRS at Weeks 4, 12 and 24.
WI-NRS is a validated measure of itch severity. Participants are asked daily to rate the intensity of their worst pruritis (itch) over the past 24 hours using an 11-point scale ranging from 0= no itch to 10= worst imaginable itch. Higher scores indicate more severity.
Measured: From Day 1 (first dose) to Day 169 (week 24)
Percentage change from baseline in WI-NRS at Weeks 4, 12 and 24.
WI-NRS is a validated measure of itch severity. Participants are asked daily to rate the intensity of their worst pruritis (itch) over the past 24 hours using an 11-point scale ranging from 0= no itch to 10= worst imaginable itch. Higher scores indicate more severity.
Measured: From Day 1 (first dose) to Day 169 (week 24)
Absolute change from baseline in Sleep Quality Numerical Rating Scale (SQ-NRS) at Weeks 4, 12 and 24.
SQ-NRS is an assessment where participants rate their sleep during the past 24 hours as a score ranging from 0= best possible sleep to 10= worst possible sleep. Higher scores indicate more severity.
Measured: From Day 1 (first dose) to Day 169 (week 24)
Percentage change from baseline in SQ-NRS at Weeks 4, 12 and 24.
SQ-NRS is an assessment where participants rate their sleep during the past 24 hours as a score ranging from 0= best possible sleep to 10= worst possible sleep. Higher scores indicate more severity.
Measured: From Day 1 (first dose) to Day 169 (week 24)
Absolute change from baseline in Worst Pain Numerical Rating Scale (WP-NRS) at Weeks 4, 12 and 24.
WP-NRS is used to measure skin pain intensity. Participants are asked to rate their worst pain during the past 24 hours as a score ranging from 0= no pain to 10= worst imaginable pain. Higher scores indicate more severity.
Measured: From Day 1 (first dose) to Day 169 (week 24)
Percentage change from baseline in WP-NRS at Weeks 4, 12 and 24.
Worst Pain Numerical Rating Scale (WP-NRS) is used to measure skin pain intensity. Participants are asked to rate their worst pain during the past 24 hours as a score ranging from 0= no pain to 10= worst imaginable pain. Higher scores indicate more severity.
Measured: From Day 1 (first dose) to Day 169 (week 24)
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.
PROMIS Fatigue-SF Daily is an assessment where participants rate their fatigue on a daily basis by responding to 7 questions. Each question is based on a 5-point scale ranging from 1= never to 5= always.
Measured: From Day 1 (first dose) to Day 169 (week 24)
Percentage change from baseline in PROMIS Fatigue-SF Daily at Weeks 4, 12 and 24.
Patient-Reported Outcomes Measurement Information System Fatigue - Short Form 7b Daily (PROMIS Fatigue-SF Daily) is an assessment where participants rate their fatigue on a daily basis by responding to 7 questions. Each question is based on a 5-point scale ranging from 1= never to 5= always.
Measured: From Day 1 (first dose) to Day 169 (week 24)
Absolute change from baseline in Dermatology Life Quality Index (DLQI) at Weeks 4, 12 and 24.
The DLQI is a self-administered, dermatology-specific quality of life (QoL) questionnaire that consists of 10 questions concerning participants' perception of the impact of their skin disease on different aspects of their QoL (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment) over the previous week. The DLQI score ranges from 0= no effect on the participant's life to 30= extremely large effect on the participant's life.
Measured: From Day 1 (first dose) to Day 169 (week 24)
Percentage change from baseline in Dermatology Life Quality Index (DLQI) at Weeks 4, 12 and 24.
The DLQI is a self-administered, dermatology-specific quality of life (QoL) questionnaire that consists of 10 questions concerning participants' perception of the impact of their skin disease on different aspects of their QoL (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment) over the previous week. The DLQI score ranges from 0= no effect on the participant's life to 30= extremely large effect on the participant's life.
Measured: From Day 1 (first dose) to Day 169 (week 24)
Proportion of participants with WI-NRS score < 2 at Weeks 4, 12 and 24.
WI-NRS is a validated measure of itch severity. Participants are asked daily to rate the intensity of their worst pruritis (itch) over the past 24 hours using an 11-point scale ranging from 0 = no itch to 10 = worst imaginable itch. Higher scores indicate more severity. In this outcome measure, the proportion of participants with an improvement (reduction) in WI-NRS to a score of < 2 at Weeks 4, 12 and 24, will be reported.
Measured: From Day 1 (first dose) to Day 169 (week 24)
Proportion of participants with improvement in SQ-NRS by ≥ 4 from baseline to Week 4, 12 and 24.
Sleep Quality Numerical Rating Scale (SQ-NRS) is an assessment where participants rate their sleep during the past 24 hours as a score ranging from 0 = best possible sleep to 10 = worst possible sleep. Higher scores indicate more severity.
Measured: From Day 1 (first dose) to Day 169 (week 24)
Proportion of participants with improvement in WP-NRS by ≥ 4 from baseline to Weeks 4, 12 and 24.
Worst Pain Numerical Rating Scale (WP-NRS) is used to measure skin pain intensity. Participants are asked to rate their worst pain during the past 24 hours as a score ranging from 0 = no pain to 10 = worst imaginable pain. Higher scores indicate more severity.
Measured: From Day 1 (first dose) to Day 169 (week 24)
Proportion of participants with improvement of ≥ 4 in DLQI from baseline to Weeks 4, 12 and 24.
The DLQI is a self-administered, dermatology-specific quality of life (QoL) questionnaire that consists of 10 questions concerning participants' perception of the impact of their skin disease on different aspects of their QoL (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment) over the previous week. The DLQI score ranges from 0= no effect on the participant's life to 30= extremely large effect on the participant's life. Proportion of participants with improvement in DLQI scores of ≥ 4 points from baseline to Weeks 4,12 and 24 will be reported.
Measured: From Day 1 (first dose) to Day 169 (week 24)
Proportion of participants achieving DLQI score of 0 or 1 at Weeks 4, 12 and 24.
The DLQI is a self-administered, dermatology-specific quality of life (QoL) questionnaire that consists of 10 questions concerning participants' perception of the impact of their skin disease on different aspects of their QoL (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment) over the previous week. The DLQI score ranges from 0= no effect on the participant's life to 30= extremely large effect on the participant's life. Proportion of participants achieving DLQI scores of 0 or 1 at Weeks 4,12 and 24 will be reported.
Measured: From Day 1 (first dose) to Day 169 (week 24)
Absolute change from baseline in PGIS, PGIS-SD, PGIC and PGIC-SD.
Patient Global Impression of Severity of Disease (PGIS) is an assessment where participants rate the severity in their PN. Patient Global Impression of Severity of Sleep Disturbance (PGIS-SD) is an assessment where participants rate the severity of their sleep disturbance. PGIS and PGIS-SD are gauged on a scale ranging from 0= none to 4= very severe.
Patient Global Impression of Change of Disease (PGIC) is an assessment where participants rate the change in their PN. Patient Global Impression of Change of Sleep Disturbance (PGIC-SD) is an assessment where the participants rate the change in their sleep disturbance. PGIC and PGIC-SD are gauged on a scale of 1= Much better to 5= Much worse. Participants will be asked to provide this rating in comparison to just before the participant starts taking study treatment.
Measured: From Day 1 (first dose) to Day 169 (week 24)
Percentage change from baseline in PGIS, PGIS-SD, PGIC and PGIC-SD at Weeks 4, 12 and 24.
PGIS is an assessment where participants rate the change in their PN. PGIS-SD is an assessment where participants rate the severity of their sleep disturbance. PGIS and PGIS-SD are gauged on a scale ranging from 0= none to 4= very severe.
PGIC is an assessment where participants rate the change of their PN. PGIC-SD is an assessment where the participants rate the change in their sleep disturbance. PGIC and PGIC-SD are gauged on a scale of 1= Much better to 5= Much worse. Participants will be asked to provide this rating in comparison to just before the participant starts taking study treatment.
Measured: From Day 1 (first dose) to Day 169 (week 24)
Number of participants with Treatment-Emergent Adverse Events (TEAEs) throughout the study.
An adverse event (AE) is any untoward medical occurrence in a participant administered study treatment and does not have to have a causal relationship with the treatment. TEAEs are defined as AEs that develop, worsen or become serious during the treatment- emergent (TE) period from the first investigational medicinal product (IMP) administration to the last IMP administration.
Measured: From Day 1 (first dose) to Day 281 (last follow-up visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start12 Apr 2024
- Primary completion17 Mar 2026
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prurigo NodularisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celldex Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06366750
- Sponsor's protocol ID
- CDX0159-10
- Other IDs
- 2023-510279-80-00, 2023
- Status last verified
- Jul 2026
- First submitted
- 27 Mar 2024
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06366750
- Acronym / sponsor ID
- CDX0159-10
- Conditions
- Prurigo Nodularis
- Keywords
- barzolvolimab, PN, CDX-0159
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Celldex TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 12 Apr 2024 (actual)
- Primary completion
- 17 Mar 2026 (actual)
- Study completion
- Mar 2027 (estimated)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Following the completion of the treatment period, participants may enter an open label extension portion of the study if they are eligible.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Barzolvolimab 450 mg, then 150 mg Q4W | Experimental | Biological: barzolvolimab450 mg subcutaneous administration loading dose on Day 1 followed by 150 mg subcutaneous administration every 4 weeks, starting on Week 4, to Week 24. |
| Barzolvolimab 450 mg, then 300 mg Q4W | Experimental | Biological: barzolvolimab450 mg subcutaneous administration loading dose on Day 1 followed by 300 mg subcutaneous administration every 4 weeks, starting on Week 4, to Week 24. |
| Placebo | Placebo comparator | Other: Matching PlaceboMatching placebo subcutaneous administration every 4 weeks, starting on Week 4, to Week 24. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males and females, ≥18 years of age.
- Diagnosis of Prurigo Nodularis by a dermatologist at least 3 months prior to Screening with:
- 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.
- Documented history of inadequate response to prescription topical medications or for whom topical medications are medically inadvisable.
- Willing to apply a topical moisturizer (emollient) once or twice a day throughout the study.
Key exclusion criteria (10 listed)
- PN due to neuropathy, psychiatric disorders or medications.
- Unilateral PN lesions limited to small area on one side of the body (e.g., only one arm affected).
- Active unstable pruritic skin conditions in addition to PN.
- Documented atopic dermatitis (moderate to severe) within 6 months before the start of screening.
- Females who are pregnant or nursing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| barzolvolimabsubcutaneous administration | Biological | Barzolvolimab 450 mg, then 150 mg Q4W, Barzolvolimab 450 mg, then 300 mg Q4W |
| Matching Placebosubcutaneous administration | Other | Placebo |
Primary outcome
Proportion of participants with improvement in Worst Itch Numeric Rating Scale (WI-NRS) by ≥ 4 from baseline to Week 12.
Time frame: From Day 1 (first dose) to Day 85 (week 12)
WI-NRS is a validated measure of itch severity. Participants are asked daily to rate the intensity of their worst pruritis (itch) over the past 24 hours using an 11-point scale ranging from 0= no itch to 10= worst imaginable itch. Higher scores indicate more severity.
24 secondary outcomes
Proportion of participants with improvement in WI-NRS by ≥ 4 from baseline to Week 4.
Time frame: From Day 1 (first dose) to Week 4
Proportion of participants with improvement in WI-NRS by ≥ 4 from baseline to Week 24.
Time frame: From Day 1 (first dose) to Week 24
Proportion of participants with improvement in WI-NRS by ≥ 4 from baseline to Day 169 (week 24).
Time frame: From Day 1 (first dose) to Day 169 (week 24)
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.
Time frame: From Day 1 (first dose) to Day 169 (week 24)
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.
Time frame: From Day 1 (first dose) to Day 169 (week 24)
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.
Time frame: From Day 1 (first dose) to Day 169 (week 24)
Absolute change from baseline in WI-NRS at Weeks 4, 12 and 24.
Time frame: From Day 1 (first dose) to Day 169 (week 24)
Percentage change from baseline in WI-NRS at Weeks 4, 12 and 24.
Time frame: From Day 1 (first dose) to Day 169 (week 24)
Absolute change from baseline in Sleep Quality Numerical Rating Scale (SQ-NRS) at Weeks 4, 12 and 24.
Time frame: From Day 1 (first dose) to Day 169 (week 24)
Percentage change from baseline in SQ-NRS at Weeks 4, 12 and 24.
Time frame: From Day 1 (first dose) to Day 169 (week 24)
Absolute change from baseline in Worst Pain Numerical Rating Scale (WP-NRS) at Weeks 4, 12 and 24.
Time frame: From Day 1 (first dose) to Day 169 (week 24)
Percentage change from baseline in WP-NRS at Weeks 4, 12 and 24.
Time frame: From Day 1 (first dose) to Day 169 (week 24)
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.
Time frame: From Day 1 (first dose) to Day 169 (week 24)
Percentage change from baseline in PROMIS Fatigue-SF Daily at Weeks 4, 12 and 24.
Time frame: From Day 1 (first dose) to Day 169 (week 24)
Absolute change from baseline in Dermatology Life Quality Index (DLQI) at Weeks 4, 12 and 24.
Time frame: From Day 1 (first dose) to Day 169 (week 24)
Percentage change from baseline in Dermatology Life Quality Index (DLQI) at Weeks 4, 12 and 24.
Time frame: From Day 1 (first dose) to Day 169 (week 24)
Proportion of participants with WI-NRS score < 2 at Weeks 4, 12 and 24.
Time frame: From Day 1 (first dose) to Day 169 (week 24)
Proportion of participants with improvement in SQ-NRS by ≥ 4 from baseline to Week 4, 12 and 24.
Time frame: From Day 1 (first dose) to Day 169 (week 24)
Proportion of participants with improvement in WP-NRS by ≥ 4 from baseline to Weeks 4, 12 and 24.
Time frame: From Day 1 (first dose) to Day 169 (week 24)
Proportion of participants with improvement of ≥ 4 in DLQI from baseline to Weeks 4, 12 and 24.
Time frame: From Day 1 (first dose) to Day 169 (week 24)
Proportion of participants achieving DLQI score of 0 or 1 at Weeks 4, 12 and 24.
Time frame: From Day 1 (first dose) to Day 169 (week 24)
Absolute change from baseline in PGIS, PGIS-SD, PGIC and PGIC-SD.
Time frame: From Day 1 (first dose) to Day 169 (week 24)
Percentage change from baseline in PGIS, PGIS-SD, PGIC and PGIC-SD at Weeks 4, 12 and 24.
Time frame: From Day 1 (first dose) to Day 169 (week 24)
Number of participants with Treatment-Emergent Adverse Events (TEAEs) throughout the study.
Time frame: From Day 1 (first dose) to Day 281 (last follow-up visit)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
72 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing barzolvolimab in people with Prurigo Nodularis, run by Celldex Therapeutics at 72 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 72 sites in United States, Poland, Germany, Canada, Spain and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with improvement in Worst Itch Numeric Rating Scale (WI-NRS) by ≥ 4 from baseline to Week 12. (time frame: From Day 1 (first dose) to Day 85 (week 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.