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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-510279-80-00 | Other Identifier | EU CT |
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The purpose of this study is to assess the efficacy and safety of barzolvolimab in adults with prurigo nodularis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Placebo | Placebo Comparator | Matching placebo subcutaneous administration every 4 weeks, starting on Week 4, to Week 24. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| barzolvolimab | Biological | subcutaneous administration |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | From Day 1 (first dose) to Day 85 (week 12) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From Day 1 (first dose) to Week 4 |
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Key Inclusion Criteria:
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.
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.
Key Exclusion Criteria
There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Total Dermatology | Birmingham | Alabama | 35203 | United States | ||
| Cahaba Dermatology Skin Health Center |
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| Matching Placebo | Other | subcutaneous administration |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | From Day 1 (first dose) to Day 281 (last follow-up visit) |
| Birmingham |
| Alabama |
| 35244 |
| United States |
| Investigate MD, LLC | Scottsdale | Arizona | 85255 | United States |
| Scottsdale Clinical Trials | Scottsdale | Arizona | 85260 | United States |
| Center for Dermatology Clinical Research, Inc | Fremont | California | 94538 | United States |
| Profound Research LLC | Oceanside | California | 92056 | United States |
| Empire Clinical Research | Pomona | California | 91767 | United States |
| University of California San Francisco | San Francisco | California | 94115 | United States |
| University of California, San Francisco | San Francisco | California | 94115 | United States |
| Dermatology Institute & Skin Care Center | Santa Monica | California | 90404 | United States |
| Focus Clinical Research | West Hills | California | 91307 | United States |
| Encore Medical Research Boynton Beach | Boynton Beach | Florida | 33436 | United States |
| Biobrilliance Medical Research Center | Hialeah | Florida | 33106 | United States |
| Encore Medical Research | Hollywood | Florida | 33024 | United States |
| Life Arc Research Centers Corp | Miami | Florida | 33126 | United States |
| University of Miami | Miami | Florida | 33134 | United States |
| Advanced Clinical Research Institute | Tampa | Florida | 33607 | United States |
| Encore Medical Research of Weston | Weston | Florida | 33331 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Centricity Research | Columbus | Georgia | 31904 | United States |
| Treasure Valley Medical Research | Boise | Idaho | 83706 | United States |
| MetroMed Clinical Trials | Chicago | Illinois | 60614 | United States |
| DS Research of Southern Indiana, LLC | Clarksville | Indiana | 47129 | United States |
| Equity Medical | Bowling Green | Kentucky | 42104 | United States |
| DS Research of Kentucky, LLC | Louisville | Kentucky | 40241 | United States |
| Revival Research Institute, LLC | Troy | Michigan | 48084 | United States |
| Medisearch, LLC | Saint Joseph | Missouri | 64506 | United States |
| Skin Specialists PC | Omaha | Nebraska | 68144 | United States |
| University of New Mexico Department of Dermatology | Albuquerque | New Mexico | 87102 | United States |
| Equity Medical | New York | New York | 10023 | United States |
| Apex Clinical Research Center - Canton | Canton | Ohio | 44718 | United States |
| UC Health Physicians Office Dermatology | Cincinnati | Ohio | 45219 | United States |
| Paddington Testing, PO | Philadelphia | Pennsylvania | 01913 | United States |
| Columbia Dermatology and Aesthetics | Columbia | South Carolina | 29212 | United States |
| International Clinical Research - Tennessee LLC | Murfreesboro | Tennessee | 37130 | United States |
| Dermatology Treatment and Research Center | Dallas | Texas | 75230 | United States |
| Center for Clinical Studies | Webster | Texas | 77598 | United States |
| Stratica Dermatology | Edmonton | Alberta | Canada |
| SimcoDerm Medical and Surgical Dermatology Center | Barrie | Ontario | Canada |
| Kingsway Clinical Research | Etobicoke | Ontario | Canada |
| Guelph Dermatology Research | Guelph | Ontario | Canada |
| Derm Effects | London | Ontario | Canada |
| North York Research Inc | Toronto | Ontario | Canada |
| Special Hospital Medico | Rijeka | Croatia |
| University Hospital Center - Rijeka | Rijeka | Croatia |
| Solmed Clinic | Zagreb | Croatia |
| Universitätsklinikum Augsburg | Augsburg | Germany |
| Fachklinik Bad Bentheim, Klinisches Studienzentrum | Bad Bentheim | Germany |
| Institut für Allergieforschung (IFA),Charité - Universitätsmedizin Berlin | Berlin | Germany |
| Katholisches Klinikum Bochum | Bochum | Germany |
| Universitätsklinikum Erlangen - Hautklinik | Erlangen | Germany |
| Universitätsklinikum RWTH Aachen- Dermatology | Frankfurt | 52074 | Germany |
| Universtätsklinikum Frankfurt, Klinik für Dermatologie, Venerologie und | Frankfurt | Germany |
| University Hospital Heidelberg | Heidelberg | Germany |
| Universitätsklinikum Münster (UKM) | Münster | Germany |
| Universitätsklinikum Tübingen - Hautklinik | Tübingen | Germany |
| Centrum Nowoczesnych Terapii "Dobry Lekarz" | Krakow | Małopolska | Poland |
| FutureMeds Gdynia | Gdynia | Poland |
| Centrum Medyczne Pratia Katowice | Katowice | Poland |
| Gyncentrum sp. z o.o. | Katowice | Poland |
| Pratia MCM Krakόw | Krakow | Poland |
| LUXDERM Specjalistyczny Gabinet | Lublin | Poland |
| Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie | Rzeszów | Poland |
| Clinical /research group Z.o.o. | Warsaw | Poland |
| Gyncentrum sp. z o.o., NZOZ Gyncentrum - Oddział Warszawa | Warsaw | Poland |
| Klinika Ambroziak Dermatologia | Warsaw | Poland |
| DERMACEUM Centrum Badan | Wroclaw | Poland |
| Complexo Hospitalario Universitario de Santiago de Compostela | A Coruña | Spain |
| Hospital General Universitario Dr Balmis, ISABIAL | Alicante | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Spain |
| FutureMeds - Madrid | Madrid | Spain |
| FutureMeds - Sevilla | Seville | Spain |