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An Efficacy and Safety Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis

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ClinicalTrials.gov Identifier: NCT04501666
Recruitment Status : Recruiting
First Posted : August 6, 2020
Last Update Posted : May 2, 2022
Sponsor:
Information provided by (Responsible Party):
Galderma R&D

Tracking Information
First Submitted Date  ICMJE July 30, 2020
First Posted Date  ICMJE August 6, 2020
Last Update Posted Date May 2, 2022
Actual Study Start Date  ICMJE September 11, 2020
Estimated Primary Completion Date September 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 5, 2020)
  • Proportion of Participants with an Improvement of Greater than or Equal to (>=) 4 from Baseline in Peak Pruritus (PP) Numeric Rating Scale (NRS) at Week 16 [ Time Frame: Week 16 ]
    PP NRS is an 11-point scale (0 to10) where 0 is "no itch" and 10 is the "worst itch imaginable".
  • Proportion of Participants with an Investigator Global Assessment (IGA) Success (Defined as an IGA of 0 [Clear] or 1 [Almost clear] and a >= 2-Point Improvement from Baseline) at Week 16 [ Time Frame: Week 16 ]
    IGA is a 5-point scale used by the investigator or trained designee to evaluate the global severity of PN. The Investigator will review the participant's skin and give a score of 0 (Clear), 1 (Almost clear), 2 (Mild), 3 (Moderate), or 4 (Severe).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2020)
  • Number of Participants with Adverse Events, Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs) [ Time Frame: Up to 36 weeks ]
    An AE is defined as any untoward medical occurrence in a clinical study participant administered a medicinal product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not it is related to the medicinal (investigational) product.
  • Proportion of Participants with an Improvement of >= 4 from Baseline in PP NRS at Week 4 [ Time Frame: Week 4 ]
  • Proportion of Participants with PP NRS < 2 at Week 16 [ Time Frame: Week 16 ]
  • Proportion of Participants with an Improvement of >= 4 from Baseline in Sleep Disturbance (SD) NRS at Week 16 [ Time Frame: Week 16 ]
    SD NRS is an 11-point scale (0 to10) where 0 is "no sleep loss" and 10 is "I did not sleep at all".
  • Proportion of Participants with an Improvement of >= 4 from Baseline in SD NRS at Week 4 [ Time Frame: Week 4 ]
  • Proportion of Participants with PP NRS < 2 at Week 4 [ Time Frame: Week 4 ]
  • IGA Success Rate at Each Visit Through Week 24 [ Time Frame: At Each Visit Through Week 24 ]
  • Percentage of Pruriginous Lesions with Excoriations/Crusts ((Prurigo Activity Score [PAS] item 5a) at Each Visit Through Week 24 [ Time Frame: At Each Visit Through Week 24 ]
    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 Healed Prurigo Lesions (PAS item 5b) at Each Visit Through Week 24 [ Time Frame: At Each Visit Through Week 24 ]
    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 lesions have healed.
  • Change from Baseline in Number of Lesions in Representative Area (PAS item 4) at Each Visit Through Week 24 [ Time Frame: Baseline, at each visit through Week 24 ]
    PAS Item 4 is measure of number of lesions in representative area.
  • Proportion of Participants with an Improvement of >= 4 from Baseline in PP NRS Through Week 24 [ Time Frame: Through Week 24 ]
  • Proportion of Participants with PP NRS < 2 Through Week 24 [ Time Frame: Through Week 24 ]
  • Proportion of Participants with PP NRS < 3 Through Week 24 [ Time Frame: Through Week 24 ]
  • Percent Change from Baseline in PP NRS Through Week 24 [ Time Frame: Baseline, through Week 24 ]
  • Absolute Change from Baseline in PP NRS Through Week 24 [ Time Frame: Baseline, through Week 24 ]
  • Proportion of Participants with an Improvement of >= 4 from Baseline in Average Pruritus (AP) NRS Through Week 24 [ Time Frame: Through Week 24 ]
    AP NRS is an 11-point scale (0 to10) where 0 is "no itch" and 10 is the "worst itch imaginable".
  • Proportion of Participants with AP NRS < 2 from Baseline Through Week 24 [ Time Frame: Through Week 24 ]
  • Absolute Change from Baseline in AP NRS Through Week 24 [ Time Frame: Baseline, Through Week 24 ]
  • Percent Change from Baseline in AP NRS Through Week 24 [ Time Frame: Baseline, Through Week 24 ]
  • Proportion of Participants with an Improvement of >= 4 from Baseline in SD NRS Through Week 24 [ Time Frame: Through Week 24 ]
  • Absolute Change from Baseline in SD NRS Through Week 24 [ Time Frame: Baseline, through Week 24 ]
  • Percent Change from Baseline in SD NRS Through Week 24 [ Time Frame: Baseline, through Week 24 ]
  • Change from Baseline in Sleep Onset Latency Through Week 24 [ Time Frame: Baseline, through Week 24 ]
  • Change from Baseline in Wakefulness After Sleep Onset (WASO) Through Week 24 [ Time Frame: Baseline, through Week 24 ]
    Change from baseline in WASO, defined as the duration of wakefulness from the onset of persistent sleep. WASO is assessed with 3 questions: 1) How many times did you wake up due to the symptoms of prurigo nodularis (for example itching, burning), not counting the final time you woke up for the day? 2) In total, how long did the awakenings related to the symptoms of prurigo nodularis (for example itching, burning) last and 3) In total, how long did these awakenings related to other things last (for example to drink water, to go to the bathroom).
  • Change from Baseline in Total Awake and Sleep Time Through Week 24 [ Time Frame: Baseline, through Week 24 ]
  • Change from Baseline in Sleep Efficiency Through Week 24 [ Time Frame: Baseline, through Week 24 ]
    The Sleep Efficiency is the ratio of total sleep time to time in bed. This shall be assessed by responses from the following questions from participant's sleep diary: 1) What time did you get into bed? 2) What time did you try to go to sleep? 3) How long did it take you to fall asleep? 4) What time did you wake up for the day? 5) What time did you get out of bed for the day?
  • Change from Baseline in WASO Related to PN Through Week 24 [ Time Frame: Baseline, through Week 24 ]
  • Change from Baseline in Number of WASO Related to PN Through Week 24 [ Time Frame: Baseline, through Week 24 ]
  • Change from Baseline in PN-associated Pain Frequency Through Week 24 [ Time Frame: Baseline, through Week 24 ]
  • Change from Baseline in PN-associated Pain Intensity Through Week 24 [ Time Frame: Baseline, through Week 24 ]
  • Proportion of Participants Reporting low Disease Activity (Clear, Almost clear, or Mild) Based on Patient Global Assessment of Disease (PGAD) at Week 24 [ Time Frame: Week 24 ]
    For the PGAD, participants will be asked to rate their overall impression of their skin disease (prurigo nodularis) severity using a 5-point scale from "0=clear" to "5=severe".
  • Proportion of Participants Satisfied with Study Treatment (Good, Very Good, or Excellent) Based on Patient Global Assessment of Treatment (PGAT) at Week 24 [ Time Frame: Week 24 ]
    The PGAT utilizes a 5-point scale with ratings: poor, fair, good, very good, or excellent, for participants to rate the way they feel their skin disease (prurigo nodularis) is responding to the study treatment.
  • Proportion of Participants with an Improvement of >= 4 in DLQI Through Week 24 [ Time Frame: Through Week 24 ]
    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) and score ranges from 0 to 30. A higher total score indicates a poorer quality of life (QoL).
  • Change from Baseline in DLQI Through Week 24 [ Time Frame: Baseline, through Week 24 ]
  • Change from Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 24 [ Time Frame: Baseline, Week 24 ]
    HADS is a 14-question validated questionnaire completed by the participant for each subscale (i.e. depression and anxiety). Question has a multiple choice answer which is scored between 0 and 3. Questions are identified as relating to anxiety (A) or depression (D) and a summation for each area is performed leading to a total score of 0 to 21 for each area. Scores of 0 to 7 are considered normal, 8 to 10 are borderline, and >= 11 indicates clinical effects.
  • Change from Baseline in EuroQoL 5-Dimension (EQ-5D) at Week 24 [ Time Frame: Baseline, Week 24 ]
    The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).
  • Area Under Curve (AUC) of Nemolizumab in the Serum [ Time Frame: Pre-infusion, Post infusion on Day 29, 57, 85, 113, 169, 225 ]
  • Trough Level (Ctrough) of Nemolizumab in the Serum [ Time Frame: Pre-infusion, Post infusion on Day 29, 57, 85, 113, 169, 225 ]
  • Maximum Serum Concentration (Cmax) of Nemolizumab in Serum [ Time Frame: Pre-infusion, Post infusion on Day 29, 57, 85, 113, 169, 225 ]
  • Half-Life (t1/2) of Nemolizumab in Serum [ Time Frame: Pre-infusion, Post infusion on Day 29, 57, 85, 113, 169, 225 ]
  • Observed Ctrough of Nemolizumab in Serum [ Time Frame: Pre-infusion, Post infusion on Day 29, 57, 85, 113, 169, 225 ]
  • Number of Participants with Positive Anti-drug antibody (ADA) for Nemolizumab [ Time Frame: Baseline, Day 57, Day 113, Day 169/Early Termination ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Efficacy and Safety Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Subjects With Prurigo Nodularis
Brief Summary The primary objective is to assess the efficacy of nemolizumab (CD14152) compared to placebo in participants greater than or equal to (>=) 18 years of age with prurigo nodularis (PN) after a 16 week treatment period.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Prurigo Nodularis
Intervention  ICMJE
  • Drug: Nemolizumab 30 mg
    Participants will receive either 30 mg or 60 mg dose of nemolizumab as SC injection.
  • Drug: Placebo
    Participants will receive matching placebo as SC injection.
Study Arms  ICMJE
  • Experimental: Nemolizumab 30 milligram (mg)
    Participants weighing less than (<) 90 kilogram (kg) will receive two subcutaneous (SC) injections of 30 milligrams (mg) nemolizumab (60 mg loading dose) at baseline then one SC injection once for every 4 weeks (Q4W) and participants >= 90 kg will receive two SC injections of 60 mg nemolizumab at baseline (no loading dose) and two SC injections Q4W up to 24 weeks.
    Intervention: Drug: Nemolizumab 30 mg
  • Placebo Comparator: Placebo
    Participants weighing < 90 kg will receive matching placebo of two SC injections at baseline, then one SC injection Q4W and participants weighing >= 90 kg will receive matching placebo of two SC injections at baseline, then two SC injections Q4W up to 24 weeks.
    Intervention: Drug: Placebo
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 5, 2020)
270
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2022
Estimated Primary Completion Date September 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinical diagnosis of PN for at least 6 months with: (a) Pruriginous nodular lesions on upper limbs, trunk, and/or lower limbs; (b) At least 20 nodules on the entire body with a bilateral distribution; (c) Investigator Global Assessment (IGA) score >= 3 (based on the IGA scale ranging from 0 to 4, in which 3 is moderate and 4 is severe) at both the screening and baseline visits
  • Severe pruritus defined as follows on the PP NRS: (a) at the screening visit (Visit 1): PP NRS score is >= 7.0 for the 24-hour period immediately preceding the screening visit; (b) at the baseline visit (Visit 2): Mean of the daily intensity of the PP NRS score is >= 7.0 over the previous week
  • Female participants of childbearing potential (that is [i.e,], fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree to use at least 1 effective and approved method of contraception throughout the study and for 12 weeks after the last study drug injection
  • Participant is willing and able to comply with all of the time commitments and procedural requirements of the clinical study protocol, including daily diary recordings by the participant using an electronic handheld device provided for this study

Exclusion Criteria:

  • Body weight < 30 kilogram (kg)
  • Unilateral lesions of prurigo (eg, only one arm affected)
  • History of or current confounding skin condition (eg, Netherton syndrome, cutaneous T-cell lymphoma [mycosis fungoides or Sezary syndrome], chronic actinic dermatitis, dermatitis herpetiformis)
  • Participants with a current medical history of chronic obstructive pulmonary disease and/or chronic bronchitis
  • Positive serology results (hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb], hepatitis C (HCV) antibody with positive confirmatory test for HCV (eg, polymerase chain reaction [PCR]), or human immunodeficiency virus antibody) at 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
Listed Location Countries  ICMJE Austria,   Canada,   Denmark,   Germany,   Hungary,   Italy,   Poland,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04501666
Other Study ID Numbers  ICMJE RD.06.SPR.202685
2019-004293-25 ( 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 November 2021

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