Safety and Efficacy of Nemolizumab in PN

NCT03181503 | Completed Phase 2 Results FDA Drug

• 1 other identifier: RD.03.SPR.115828
• Study Type: interventional
• Target: 70
• Locations: 4 countries
• Sites: 16

Brief Summary

The aim of this study is to assess the safety and efficacy of nemolizumab in subjects with prurigo nodularis.

Conditions

Prurigo Nodularis

Outcome Measures

Primary Outcomes (3)

• Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) Score at Week 4 Using Last Observation Carried Forward (LOCF) Approach

  Pruritus NRS is a scale used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. Participants completed the assessment once daily at home in the evening. Participants were asked the following questions in their local language: 1) For average itch intensity: "on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch overall during the previous 24 hours?"; 2) For maximum itch intensity: "on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". Where, higher score indicated worst imaginable itch. Missing values including those who took rescue medication were replaced by LOCF approach.

  Baseline, Week 4

• Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Week 4 Using Multiple Imputation (MI) Method

  Pruritus NRS is a scale used by the participants to report the intensity of their pruritus (itch) during the last 24. Participants completed the assessment once daily at home in the evening. Participants were asked the following questions in their local language: 1) For average itch intensity: "on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch overall during the previous 24 hours?"; 2) For maximum itch intensity: "on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". Where, higher score indicated worst imaginable itch. Multiple imputation generated twenty-five sets of data with missing values imputed from observed data using linear regression.

  Baseline, Week 4

• Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Week 4 Using Observed Data

  Pruritus NRS is a scale used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. Participants completed the assessment once daily at home in the evening. Participants were asked the following questions in their local language: 1) For average itch intensity: "on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch overall during the previous 24 hours?"; 2) For maximum itch intensity: "on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". Where, higher score indicated worst imaginable itch.

  Baseline, Week 4

Secondary Outcomes (13)

• Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach

  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 Using LOCF Approach

  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 Using LOCF Approach

  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 Using LOCF Approach

  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 Using LOCF Approach

  Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants received 3 subcutaneous injections of placebo (matched to nemolizumab) every 4 weeks (Q4W) up to Week 8.

Drug: CD14152 placebo

Nemolizumab 0.5 mg/kg

EXPERIMENTAL

Participants received 3 subcutaneous injections of nemolizumab 0.5 milligram per kilogram (mg/kg) Q4W up to Week 8.

Drug: CD14152 Dose A

Interventions

CD14152 Dose A DRUG

3 subcutaneous injections (every 4 weeks during the 12-week treatment period)

Also known as: Nemolizumab

Nemolizumab 0.5 mg/kg

CD14152 placebo DRUG

3 subcutaneous injections (every 4 weeks during the 12-week treatment period)

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female of at least 18 years at screening
• 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
• 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.
• 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:

You may not qualify if:

• 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
• Unilateral lesions of prurigo (e.g only one arm affected)
• Cutaneous bacterial or viral infection within 1 week before the baseline visit.
• 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,
• 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

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (16)

LKH-Univ. Klinikum Graz

Graz, Austria

Location

Centre-Hospitalier Universitaire (CHU) - Hopital Morvan - Br

Brest, France

Location

CHU de Nice - Hôpital Archet 2

Nice, France

Location

Hopital Saint-Louis - Dermatology

Paris, France

Location

Centre Hospitalier Universitaire De Toulouse

Toulouse, France

Location

Charite - Campus Charite Mitte (CCM) - Dermatologie & Allergologie - Dermatologie & Allergologie

Berlin, Germany

Location

Universitätsklinikum Bonn AöR

Bonn, Germany

Location

Klinikum der Johann-Wolfgang Goethe-Universität

Frankfurt, Germany

Location

Unikl. Schleswig-Holstein - Lübeck

Lübeck, Germany

Location

Universitätsmedizin Mainz

Mainz, Germany

Location

Klinikum Der Universität München - Campus Innenstadt - Dermatologie und Allergologie

München, Germany

Location

Universitätsklinikum Münster

Münster, Germany

Location

Eberhard-Karls Universitaet Tuebingen - Universitaets Hautkl

Tübingen, Germany

Location

Centrum Medyczne DERMED

Lodz, Poland

Location

Dermoklinika Centrum Medyczne s.c. M.Kierstan, J.Narbutt, A.Lesiak

Lodz, Poland

Location

Kliniczny Szpital Wojew. nr 1 im. F.Chopina w Rzeszowie

Rzeszów, Poland

Location

Related Publications (2)

• Kwatra SG, Rodriguez D, Dias-Barbosa C, Budhiarso I, Fofana F, Vernon M, Gabriel S, Piketty C, Puelles J. Validation of the Peak Pruritus Numerical Rating Scale as a Patient-Reported Outcome Measure in Prurigo Nodularis. Dermatol Ther (Heidelb). 2023 Oct;13(10):2403-2416. doi: 10.1007/s13555-023-00999-9. Epub 2023 Aug 24.

  PMID: 37615836 DERIVED

• Stander S, Yosipovitch G, Legat FJ, Lacour JP, Paul C, Narbutt J, Bieber T, Misery L, Wollenberg A, Reich A, Ahmad F, Piketty C. Trial of Nemolizumab in Moderate-to-Severe Prurigo Nodularis. N Engl J Med. 2020 Feb 20;382(8):706-716. doi: 10.1056/NEJMoa1908316.

  PMID: 32074418 DERIVED

MeSH Terms

Interventions

nemolizumab

Results Point of Contact

• Title: Clinical Operations
• Organization: Galderma

Clinical.Studies@galderma.com

(0) 4 93 95 70 70

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2017
• First Posted: June 8, 2017
• Study Start: October 2, 2017
• Primary Completion: September 26, 2018
• Study Completion: September 26, 2018
• Last Updated: February 19, 2020
• Results First Posted: February 19, 2020

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

PL (3); FR (4); DE (8); AU (1)