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Safety and Efficacy of Nemolizumab in PN

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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

Brief Summary:
The aim of this study is to assess the safety and efficacy of nemolizumab in subjects with purigo nodularis.

Condition or disease Intervention/treatment Phase
Prurigo Nodularis Drug: CD14152 Dose A Drug: CD14152 placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects With Prurigo Nodularis (PN)
Actual Study Start Date : October 2, 2017
Actual Primary Completion Date : September 26, 2018
Actual Study Completion Date : September 26, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Participants received 3 subcutaneous injections of placebo (matched to nemolizumab) every 4 weeks (Q4W) up to Week 8.
Drug: CD14152 placebo
3 subcutaneous injections (every 4 weeks during the 12-week treatment period)
Other Name: 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.
Drug: CD14152 Dose A
3 subcutaneous injections (every 4 weeks during the 12-week treatment period)
Other Name: Nemolizumab




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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.

  10. 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

  11. 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%.

  12. 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.

  13. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03181503


Locations
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Austria
LKH-Univ. Klinikum Graz
Graz, Austria
France
Centre-Hospitalier Universitaire (CHU) - Hopital Morvan - Br
Brest, France
CHU de Nice - Hôpital Archet 2
Nice, France
Hopital Saint-Louis - Dermatology
Paris, France
Centre Hospitalier Universitaire De Toulouse
Toulouse, France
Germany
Charite - Campus Charite Mitte (CCM) - Dermatologie & Allergologie - Dermatologie & Allergologie
Berlin, Germany
Universitätsklinikum Bonn AöR
Bonn, Germany
Klinikum der Johann-Wolfgang Goethe-Universität
Frankfurt, Germany
Unikl. Schleswig-Holstein - Lübeck
Lubeck, Germany
Universitätsmedizin Mainz
Mainz, Germany
Klinikum Der Universität München - Campus Innenstadt - Dermatologie und Allergologie
München, Germany
Universitätsklinikum Münster
Münster, Germany
Eberhard-Karls Universitaet Tuebingen - Universitaets Hautkl
Tuebingen, Germany
Poland
Kliniczny Szpital Wojew. nr 1 im. F.Chopina w Rzeszowie
Rzeszów, Poland
Centrum Medyczne DERMED
Łódź, Poland
Dermoklinika Centrum Medyczne s.c. M.Kierstan, J.Narbutt, A.Lesiak
Łódź, Poland
Sponsors and Collaborators
Galderma R&D

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Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT03181503     History of Changes
Other Study ID Numbers: RD.03.SPR.115828
First Posted: June 8, 2017    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prurigo
Skin Diseases