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A Long-term Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04204616
Recruitment Status : Not yet recruiting
First Posted : December 19, 2019
Last Update Posted : August 5, 2020
Sponsor:
Information provided by (Responsible Party):
Galderma R&D

Tracking Information
First Submitted Date  ICMJE December 17, 2019
First Posted Date  ICMJE December 19, 2019
Last Update Posted Date August 5, 2020
Estimated Study Start Date  ICMJE September 11, 2020
Estimated Primary Completion Date August 5, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2019)
Incidence of Adverse Events by Severity [ Time Frame: Up to 64 weeks ]
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. An assessment of severity grade will be made by investigator as follow: mild (an AE that is easily tolerated by the participant, causes minimal discomfort, and does not interfere with everyday activities), moderate (An AE that is sufficiently discomforting to interfere with normal everyday activities; intervention may be needed) and severe (an AE that prevents normal everyday activities; treatment or other intervention usually needed).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2020)
  • Percentage of Participants with an Investigator Global Assessment (IGA) Success up to Week 52 [ Time Frame: Up to Week 52 ]
    Percentage of participants with an IGA success (defined as IGA of 0 [Clear] or 1 [Almost clear]) up to Week 52 will be reported.
  • Percentage of Participants with an Improvement of >=4 from Baseline in Peak Pruritus (PP) Numeric Rating Scale (NRS) up to Week 52 [ Time Frame: Baseline up to Week 52 ]
    Percentage of participants with an improvement of >= 4 from baseline in PP NRS up to Week 52 will be reported. The PP NRS has a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable".
  • Percentage of Participants with Low Disease Activity State up to Week 52 [ Time Frame: Up to Week 52 ]
    Percentage of participants with low disease activity state (that is, IGA <=2) up to Week 52 will be reported.
  • Percentage of Pruriginous Lesions with Excoriations/Crusts up (PAS item 5a) up to Week 52 [ Time Frame: Up to Week 52 ]
    PAS will include a count of the number of lesions in a representative area and a calculated staging (stage 0 to stage 4) based on the percentage of lesions with excoriations/crusts and healed lesions compared to all lesions. PAS item 5a reflects the current itch/scratch activity. It is used to estimate what percentage of the pruriginous legions show excoriations/crusts. 100 percent (%) = All pruriginous lesions have excoriations/crusts. Percentage of pruriginous lesions with excoriations/crusts (PAS item 5a) up to Week 52 will be reported.
  • Percentage of Healed Prurigo Lesions (PAS item 5b) up to Week 52 [ Time Frame: Up to Week 52 ]
    PAS item 5b item reflects the stage of the prurigo. It is used to estimate what percentage of the pruriginous lesions have healed.100% = all pruriginous leasions have healed. Percentage of healed prurigo lesions (PAS item 5b) up to Week 52 will be reported.
  • Change from Baseline in Number of Lesions in Representative Area (PAS item 4) up to Week 52 [ Time Frame: Baseline up to Week 52 ]
    Change from baseline in number of lesions in representative area (PAS item 4) up to Week 52 will be reported.
  • Percentage of Participants with PP NRS <2 up to Week 52 [ Time Frame: Up to Week 52 ]
    Percentage of participants with PP NRS <2 up to Week 52 will be reported. PP NRS is a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable".
  • Percent Change from Baseline in PP NRS up to Week 52 [ Time Frame: Baseline up to Week 52 ]
    Percent change from baseline in PP NRS up to Week 52 will be reported.
  • Absolute Change from Baseline in PP NRS up to Week 52 [ Time Frame: Baseline up to Week 52 ]
    Absolute change from baseline in PP NRS up to Week 52 will be reported.
  • Percentage of Participants with Average Pruritus (AP) NRS <2 up to Week 52 [ Time Frame: Up to Week 52 ]
    Percentage of participants with AP NRS less than (<) 2 up to Week 52 will be reported. AP NRS has a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable".
  • Percentage of Participants with an Improvement of >=4 from Baseline in AP NRS up to Week 52 [ Time Frame: Up to Week 52 ]
    Percentage of participants with an improvement of >=4 from baseline in AP NRS up to Week 52 will be reported.
  • Percent Change from Baseline in AP NRS up to Week 52 [ Time Frame: Up to Week 52 ]
    Percent change from baseline in AP NRS up to Week 52 will be reported.
  • Absolute Change from Baseline in AP NRS up to Week 52 [ Time Frame: Up to Week 52 ]
    Absolute change from baseline in AP NRS up to Week 52 will be reported.
  • Percentage of Participants with an Improvement of >=4 from Baseline in Sleep Disturbance (SD) NRS up to Week 52 [ Time Frame: Up to Week 52 ]
    Percentage of participants with an improvement of >=4 from baseline in Sleep Disturbance (SD) NRS up to Week 52 will be reported. SD NRS has a scale of 0 to 10, with 0 being "no sleep loss related to the symptoms of my skin disease (prurigo nodularis)" and 10 being "I did not sleep at all due to the symptoms of my skin disease (prurigo nodularis)".
  • Percent Change from Baseline in SD NRS up to Week 52 [ Time Frame: Up to Week 52 ]
    Percent change from baseline in SD NRS up to Week 52 will be reported.
  • Absolute Change from Baseline in SD NRS up to Week 52 [ Time Frame: Up to Week 52 ]
    Absolute change from baseline in SD NRS up to Week 52 will be reported.
  • Change from Baseline in Prurigo Nodularis (PN)-associated Pain Frequency up to Week 52 [ Time Frame: Baseline up to Week 52 ]
    Change from baseline in PN-associated pain frequency up to Week 52 will be reported. The pain frequency will be assessed on a scale of 0 to 5 where 0 = never, 1 = less than once a week, 2 = 1-2 days a week, 3 = 3-4 days a week, and 4 = 5-6 days a week.
  • Change from Baseline in PN-associated Pain Intensity up to Week 52 [ Time Frame: Baseline up to Week 52 ]
    Change from baseline in PN-associated pain intensity up to Week 52 will be reported. The pain intensity will be assessed on a scale of 0 to 10, with 0 being "no pain" and 10 being "the worst unbearable pain".
  • Percentage of Participants Reporting low Disease Activity Based on Patient Global Assessment of Disease (PGAD) up to Week 52 [ Time Frame: Up to Week 52 ]
    Percentage of participants reporting low disease activity (clear, almost clear, or mild) based on Patient Global Assessment of Disease (PGAD) up to Week 52 to be reported.
  • Percentage of Participants Satisfied with Study Treatment Based on Patient Global Assessment of Treatment (PGAT) up to Week 52 [ Time Frame: Up to Week 52 ]
    Percentage of participants satisfied with study treatment (good, very good, or excellent) based on Patient Global Assessment of Treatment (PGAT) up to Week 52 will be reported.
  • Percentage of Participants with an Improvement of >=4 from Baseline in Dermatology Life Quality Index (DLQI) up to Week 52 [ Time Frame: Baseline up to Week 52 ]
    Percentage of participants with an improvement of >=4 from baseline in Dermatology Life Quality Index (DLQI) up to Week 52 will be reported. The DLQI is a validated 10-item questionnaire covering domains including symptoms/feelings, daily activities, leisure, work/school, personal relationships, and treatment. The participant will rate each question ranging from 0 (not at all) to 3 (very much). A higher total score indicates a poorer quality of life (QoL).
  • Change from Baseline in EuroQoL 5-Dimension (EQ-5D) up to Week 52 [ Time Frame: Baseline up to Week 52 ]
    Change from baseline in EuroQoL 5-Dimension (EQ-5D) up to Week 52 will be reported. The EQ-5D instrument is a validated questionnaire, completed by the participant that consists of 2 parts. The first part consists of 5 multiple choice QoL questions and the second is a 100 point Visual Analog Scale (VAS) with 0 being "Worst imaginable health state" and 100 being "Best imaginable health state".
Original Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2019)
  • Percentage of Participants with an Investigator Global Assessment (IGA) Success Each Visit up to Week 52 [ Time Frame: Up to Week 52 ]
    Percentage of participants with an IGA success (defined as IGA of 0 [Clear] or 1 [Almost clear] and a greater than or equal to [>=] 2-point improvement from baseline) at each visit up to Week 52 will be reported.
  • Percentage of Participants with an Improvement of >=4 from Baseline in Peak Pruritus (PP) Numeric Rating Scale (NRS) up to Week 52 [ Time Frame: Baseline up to Week 52 ]
    Percentage of participants with an improvement of >= 4 from baseline in PP NRS up to Week 52 will be reported. The PP NRS has a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable".
  • Percentage of Participants with Low Disease Activity State at Each Visit up to Week 52 [ Time Frame: Up to Week 52 ]
    Percentage of participants with low disease activity state (that is, IGA <=2) at each visit up to Week 52 will be reported.
  • Percentage of Participants with Prurigo Nodularis Activity (PN-A) Success at Each Visit up to Week 52 [ Time Frame: Up to Week 52 ]
    Percentage of participants with PN-A success (defined as score of 0 [Clear] or 1 [Almost clear]) at each visit up to Week 52 will be reported.
  • Percentage of Participants with Prurigo Nodularis Stage (PN-S) Success at Each Visit up to Week 52 [ Time Frame: Up to Week 52 ]
    Percentage of participants with PN-S success (defined as score of 0 [Clear] or 1 [Almost clear]) at each visit up to Week 52 will be reported.
  • Percentage of Pruriginous Lesions with Excoriations/Crusts at Each Visit up to Week 52 [ Time Frame: Up to Week 52 ]
    Percentage of pruriginous lesions with excoriations/crusts at each visit up to Week 52 will be reported.
  • Percentage of Healed Prurigo Lesions at Each Visit up to Week 52 [ Time Frame: Up to Week 52 ]
    Percentage of healed prurigo lesions at each visit up to Week 52 will be reported.
  • Change from Baseline in Number of Lesions in Representative Area at Each Visit up to Week 52 [ Time Frame: Baseline up to Week 52 ]
    Change from baseline in number of lesions in representative area at each visit up to Week 52 will be reported.
  • Percentage of Participants with PP NRS <2 up to Week 52 [ Time Frame: Up to Week 52 ]
    Percentage of participants with PP NRS <2 up to Week 52 will be reported. PP NRS is a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable".
  • Percent Change from Baseline in PP NRS up to Week 52 [ Time Frame: Baseline up to Week 52 ]
    Percent change from baseline in PP NRS up to Week 52 will be reported.
  • Percentage of Participants with Average Pruritus (AP) NRS <2 up to Week 52 [ Time Frame: Up to Week 52 ]
    Percentage of participants with AP NRS less than (<) 2 up to Week 52 will be reported. AP NRS has a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable".
  • Percentage of Participants with an Improvement of >=4 from Baseline in AP NRS up to Week 52 [ Time Frame: Up to Week 52 ]
    Percentage of participants with an improvement of >=4 from baseline in AP NRS up to Week 52 will be reported.
  • Percent Change from Baseline in AP NRS up to Week 52 [ Time Frame: Up to Week 52 ]
    Percent change from baseline in AP NRS up to Week 52 will be reported.
  • Percentage of Participants with an Improvement of >=4 from Baseline in Sleep Disturbance (SD) NRS up to Week 52 [ Time Frame: Up to Week 52 ]
    Percentage of participants with an improvement of >=4 from baseline in Sleep Disturbance (SD) NRS up to Week 52 will be reported. SD NRS has a scale of 0 to 10, with 0 being "no sleep loss related to the symptoms of my skin disease (prurigo nodularis)" and 10 being "I did not sleep at all due to the symptoms of my skin disease (prurigo nodularis)".
  • Percent Change from Baseline in SD NRS up to Week 52 [ Time Frame: Up to Week 52 ]
    Percent change from baseline in SD NRS up to Week 52 will be reported.
  • Change from Baseline in Prurigo Nodularis (PN)-associated Pain Frequency up to Week 52 [ Time Frame: Baseline up to Week 52 ]
    Change from baseline in PN-associated pain frequency up to Week 52 will be reported. The pain frequency will be assessed on a scale of 0 to 5 where 0 = never, 1 = less than once a week, 2 = 1-2 days a week, 3 = 3-4 days a week, and 4 = 5-6 days a week.
  • Change from Baseline in PN-associated Pain Intensity up to Week 52 [ Time Frame: Baseline up to Week 52 ]
    Change from baseline in PN-associated pain intensity up to Week 52 will be reported. The pain intensity will be assessed on a scale of 0 to 10, with 0 being "no pain" and 10 being "the worst unbearable pain".
  • Percentage of Participants Reporting low Disease Activity Based on Patient Global Assessment of Disease (PGAD) at Each Visit up to Week 52 [ Time Frame: Up to Week 52 ]
    Percentage of participants reporting low disease activity (clear, almost clear, or mild) based on Patient Global Assessment of Disease (PGAD) at each visit up to Week 52 to be reported.
  • Percentage of Participants Satisfied with Study Treatment Based on Patient Global Assessment of Treatment (PGAT) at Each Visit up to Week 52 [ Time Frame: Up to Week 52 ]
    Percentage of participants satisfied with study treatment (good, very good, or excellent) based on Patient Global Assessment of Treatment (PGAT) at each visit up to Week 52 will be reported.
  • Change from Baseline in Dermatology Life Quality Index (DLQI) up to Week 52 [ Time Frame: Baseline up to Week 52 ]
    Change from baseline in Dermatology Life Quality Index (DLQI) up to Week 52 will be reported. The DLQI is a validated 10-item questionnaire covering domains including symptoms/feelings, daily activities, leisure, work/school, personal relationships, and treatment. The participant will rate each question ranging from 0 (not at all) to 3 (very much). A higher total score indicates a poorer quality of life (QoL).
  • Change from Baseline in EuroQoL 5-Dimension (EQ-5D) up to Week 52 [ Time Frame: Baseline up to Week 52 ]
    Change from baseline in EuroQoL 5-Dimension (EQ-5D) up to Week 52 will be reported. The EQ-5D instrument is a validated questionnaire, completed by the participant that consists of 2 parts. The first part consists of 5 multiple choice QoL questions and the second is a 100 point Visual Analog Scale (VAS) with 0 being "Worst imaginable health state" and 100 being "Best imaginable health state".
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Long-term Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)
Official Title  ICMJE A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects With Prurigo Nodularis
Brief Summary The primary purpose of this study is to assess the long-term safety of nemolizumab (CD14152) in participants with prurigo nodularis (PN).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prurigo Nodularis
Intervention  ICMJE Drug: Nemolizumab
Nemolizumab 30 mg will be administered as SC injection.
Other Name: CD14152
Study Arms  ICMJE Experimental: Nemolizumab
Nemolizumab administered via subcutaneous injection (SC)
Intervention: Drug: Nemolizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 3, 2020)
400
Original Estimated Enrollment  ICMJE
 (submitted: December 17, 2019)
353
Estimated Study Completion Date  ICMJE September 30, 2022
Estimated Primary Completion Date August 5, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participants who may benefit from study participation in the opinion of the investigator and participated in a prior nemolizumab study for PN including: (a). Participants who completed the treatment period in a phase 3 pivotal study (RD.06.SPR.202685 or RD.06.SPR.203065) and enroll within 56 days OR (b).Participants who were previously randomized in the nemolizumab phase 2a PN study (RD.03.SPR.115828)
  • Female participants of childbearing potential (that is, fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree either to be strictly abstinent throughout the study and for 12 weeks after the last study drug injection, or to use an adequate and approved method of contraception throughout the study and for 12 weeks after the last study drug injection
  • Participant willing and able to comply with all of the time commitments and procedural requirements of the clinical study protocol, including periodic weekly recordings by the participant using an electronic handheld device provided for this study
  • Understand and sign an informed consent form (ICF) before any investigational procedure(s) are performed

Exclusion Criteria:

  • Participants who, during their participation in a prior nemolizumab study, experienced an adverse event (AE) which in the opinion of the investigator could indicate that continued treatment with nemolizumab may present an unreasonable risk for the participant
  • Pregnant women (positive pregnancy test result at screening or baseline visit), breastfeeding women, or women planning a pregnancy during the clinical study
  • Any medical or psychological condition that may put the participant at significant risk according to the investigator's judgment, if he/she participates in the clinical study, or may interfere with study assessments (example, poor venous access or needle-phobia)
  • Planning or expected to have a major surgical procedure during the clinical study
  • Participants unwilling to refrain from using prohibited medications during the clinical study
  • History of alcohol or substance abuse within 6 months prior to the screening visit
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Galderma Research & Development 817-961-5000 clinical.studies@galderma.com
Contact: Jami Smith, Senior Clinical Project Manager 817-961-5000 clinical.studies@galderma.com
Listed Location Countries  ICMJE Austria,   Belgium,   Canada,   Denmark,   France,   Germany,   Hungary,   Italy,   Korea, Republic of,   Netherlands,   Poland,   Spain,   Sweden,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04204616
Other Study ID Numbers  ICMJE RD.06.SPR.202699
2019-004294-13 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Galderma R&D
Study Sponsor  ICMJE Galderma R&D
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Galderma R&D
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP