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Safety and Efficacy of Nemolizumab in 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03181503
Recruitment Status : Completed
First Posted : June 8, 2017
Last Update Posted : September 27, 2019
Sponsor:
Information provided by (Responsible Party):
Galderma R&D

Tracking Information
First Submitted Date  ICMJE June 7, 2017
First Posted Date  ICMJE June 8, 2017
Last Update Posted Date September 27, 2019
Actual Study Start Date  ICMJE October 2, 2017
Actual Primary Completion Date September 26, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2019)
Percent Change in Peak Pruritus Numeric Rating Scale (NRS) Score [ Time Frame: Baseline, Week 4 ]
Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) Score at Week 4
Original Primary Outcome Measures  ICMJE
 (submitted: June 7, 2017)
Percent change in NRS [ Time Frame: From baseline to week 04 ]
Change History Complete list of historical versions of study NCT03181503 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2019)
  • Percent Change in Peak Pruritus Numeric Rating Scale Score [ Time Frame: Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18 ]
    Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit
  • Absolute Change in Peak Pruritus Numeric Rating Scale Score [ Time Frame: Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18 ]
    Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit
  • Percent Change in Average Pruritus Numeric Rating Scale Score [ Time Frame: Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18 ]
    Percent Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit
  • Absolute Change in Average Pruritus Numeric Rating Scale Score [ Time Frame: Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18 ]
    Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit
  • Percent Change inPeak of Pruritus Verbal Rating Scale (VRS) Score [ Time Frame: Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18 ]
    Percent Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale (VRS) Score at Each Visit
  • Absolute Change in Peak of Pruritus Verbal Rating Scale Score [ Time Frame: Baseline, Weeks 1, 2, 4, 8, 12,16 and 18 ]
    Absolute Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale Score at Each Visit
  • Percent Change in Average Pruritus Verbal Rating Scale Score [ Time Frame: Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18 ]
    Percent Change From Baseline in Weekly Average of the Average Pruritus Verbal Rating Scale Score at Each Visit
  • Absolute Change in Average Verbal Rating Scale Score [ Time Frame: Baseline, Weeks 1, 2, 4, 8, 12,16 and 18 ]
    Absolute Change From Baseline in Weekly Average of the Average Verbal Rating Scale Score at Each Visit
  • Dynamic Pruritus Score (DPS) at 24, 48, and 72 Hours After First Injection and Before Second Injection (Week 4) [ Time Frame: After 24, 48, 72 hours of first Injection and before second injection (Week 4) ]
    The 9-point DPS is a dynamic scale used by participants to evaluate the change of their pruritus compared with an earlier time point. The scale ranges from 0 (strongly worsened pruritus) to 8 ([almost] no pruritus anymore), including intermediate marks for slightly improved/worsened, moderately improved/worsened, and rather improved/worsened. Participants recorded their DPS score 24, 48 and 72 hours after the first injection at baseline and at week 4 before the second injection.
  • Percent Change From Baseline in Prurigo Activity Score (PAS) Item 5 (Number of Lesions) at Week 12 [ Time Frame: Baseline, Week 12 ]
    PAS includes 7-descriptive items; 1) lesions type (papules nodules/plaques/umbilicated ulcers/ulcers/hypo-/hyperpigmented maculae); 2) number (prurigo lesions on whole body); 3) distribution (disseminated/localized [only 1/2 areas affected]/neither of them); 4) affected areas (forearm/upper arm/lower and upper leg/trunk/head); 5) number of prurigo lesions in selected area; 6) activity (prurigo lesions with excoriations/crusts and healed prurigo lesions compared to all prurigo lesions) and 7) front and back, areas of marked monitor lesions to recognize on next visit
  • Number of Participants With Prurigo Activity Score (PAS) Item 6 (Excoriation/Crusts and Healed Lesions Stages) at Each Visit [ Time Frame: Baseline, Weeks 4, 8, 12 and 18 ]
    PAS includes 7-descriptive items; 1) lesions type (papules nodules/plaques/umbilicated ulcers/ulcers/hypo-/hyperpigmented maculae); 2) number (prurigo lesions on whole body); 3) distribution (disseminated/localized [only 1/2 areas affected]/neither of them); 4) affected areas (forearm/upper arm/lower and upper leg/trunk/head); 5) number of prurigo lesions in selected area; 6) activity (prurigo lesions with excoriations/crusts and healed prurigo lesions compared to all prurigo lesions) and 7) front and back, areas of marked monitor lesions to recognize on next visit. Item 6 has 0-4 stages where each stage represents percentage of prurigo lesions with excoriations/crusts and healed prurigo lesions compared to all prurigo lesions: excoriations/crusts lesions; stage 0=0%, 1=1-25%, 2=26-50%, 3=51-75%, 4=76-100%; for healed lesions; stage 0=100%, 1=75-99%, 2=50-74%, 3=25-49%, 4=0-24%.
  • Investigator Global Assessment (IGA) Score at Each Visit [ Time Frame: Baseline, Weeks 4, 8, 12 and 18 ]
    IGA is a 5-point scale used to evaluate the severity of the disease ranging from 0 to 4 where, 0 = clear, 1= almost clear, 2 = mild, 3 = moderate and 4 severe. IGA corresponds to the overall assessment of the severity of prurigo including presence of crust and nodules or skin bleeding. Higher score indicates greater severity of disease.
  • Percentage of Participants Achieving Investigator Global Assessment Success (Defined as IGA= 0 [Clear] or IGA = 1 [Almost Clear] With Two-point Improvement From Baseline) at Week 12 [ Time Frame: Week 12 ]
    IGA is a 5-point scale to evaluate the severity of the disease ranging from 0 to 4 where, 0 = clear, 1= almost clear, 2 = mild, 3 = moderate and 4 severe. IGA corresponds to the overall assessment of the severity of prurigo including presence of crust and nodules or skin bleeding. Higher score indicates greater severity of disease.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Nemolizumab in PN
Official Title  ICMJE A Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects With Prurigo Nodularis (PN)
Brief Summary The aim of this study is to assess the safety and efficacy of nemolizumab in subjects with purigo nodularis.
Detailed Description This is a randomized, placebo-controlled, double-blinded, parallel group, multicenter study to evaluate the safety and efficacy of nemolizumab over a 12-week treatment period in patients suffering from purigo nodularis compared to its placebo.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Prurigo Nodularis
Intervention  ICMJE
  • Drug: CD14152 Dose A
    3 subcutaneous injections (every 4 weeks during the 12-week treatment period)
    Other Name: Nemolizumab
  • Drug: CD14152 placebo
    3 subcutaneous injections (every 4 weeks during the 12-week treatment period)
    Other Name: Placebo
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Participants received 3 subcutaneous injections of placebo (matched to nemolizumab) every 4 weeks (Q4W) up to Week 8.
    Intervention: Drug: CD14152 placebo
  • Experimental: Nemolizumab 0.5 mg/kg
    Participants received 3 subcutaneous injections of nemolizumab 0.5 milligram per kilogram (mg/kg) Q4W up to Week 8.
    Intervention: Drug: CD14152 Dose A
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 Completed
Actual Enrollment  ICMJE
 (submitted: September 25, 2019)
70
Original Estimated Enrollment  ICMJE
 (submitted: June 7, 2017)
100
Actual Study Completion Date  ICMJE September 26, 2018
Actual Primary Completion Date September 26, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female of at least 18 years at screening
  2. Clinical diagnosis of PN for at least 6 months with:

    • Prurigo lesions on upper limbs with or without lesions on the trunk or lower limbs
    • At least 20 nodules on the entire body with a bilateral distribution
  3. Severe pruritus defined as follows on a Numerical Rating Scale (NRS)

    • At the Screening visit 1: Mean of the worst daily intensity of the NRS score is ≥ 7 over the previous 3 days
    • At the Baseline visit: Mean of the worst daily intensity of the NRS score is ≥ 7 over the previous week; NOTE: NRS score should be measured on at least 5 days during the week preceding the baseline visit.
  4. Female subjects must fulfill one of the criteria below:

    • Female subjects of non-childbearing potential (postmenopausal [absence of menstrual bleeding for 1 year prior to screening, without any other medical reason], hysterectomy or bilateral oophorectomy);
    • Female subjects of childbearing potential who agree to a true abstinence (when in line with the preferred and usual lifestyle of the subject), or to use an effective method of contraception throughout the clinical trial and for 120 days after the last study drug administration:

Exclusion Criteria:

  1. Chronic pruritus resulting from another condition than PN such as scabies, insect bite, lichen simplex chronicus, psoriasis, acne, folliculitis, habitual picking, lymphomatoid papulosis, chronic actinic dermatitis, dermatitis herpetiformis, sporotrichosis, bullous disease
  2. Unilateral lesions of prurigo (e.g only one arm affected)
  3. Cutaneous bacterial or viral infection within 1 week before the baseline visit.
  4. Infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics or antifungals within 1 week before the screening visit, or during the screening period, unless completely resolved at the screening/ baseline visits respectively,
  5. Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results and/or put the subject at Chronic pruritus resulting from another condition than PN such as scabies, insect bite, lichen simplex chronicus, psoriasis, acne, folliculitis, habitual picking, lymphomatoid papulosis, chronic actinic dermatitis, dermatitis herpetiformis, sporotrichosis, bullous disease
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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   France,   Germany,   Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03181503
Other Study ID Numbers  ICMJE RD.03.SPR.115828
Has Data Monitoring Committee No
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
Plan to Share IPD: No
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 September 2019

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