Clinical trial NCT03181503: Safety and Efficacy of Nemolizumab in PN
Official title: A Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects With Prurigo Nodularis (PN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prurigo Nodularis
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2017-06-08
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to assess the safety and efficacy of nemolizumab in subjects with prurigo 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 prurigo nodularis compared to its placebo.

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: Baseline, Week 4
measure: Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Week 4 Using Multiple Imputation (MI) Method
timeFrame: Baseline, Week 4
measure: Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Week 4 Using Observed Data
timeFrame: Baseline, Week 4
Secondary outcomes:
measure: Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach
timeFrame: Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18
measure: Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach
timeFrame: Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18
measure: Percent Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach
timeFrame: Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18
measure: Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach
timeFrame: Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18
measure: Percent Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale (VRS) Score at Each Visit Using LOCF Approach
timeFrame: Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18
measure: Absolute Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach
timeFrame: Baseline, Weeks 1, 2, 4, 8, 12,16 and 18
measure: Percent Change From Baseline in Weekly Average of the Average Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach
timeFrame: Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18
measure: Absolute Change From Baseline in Weekly Average of the Average Verbal Rating Scale Score at Each Visit Using LOCF Approach
timeFrame: Baseline, Weeks 1, 2, 4, 8, 12,16 and 18
measure: Dynamic Pruritus Score (DPS) at 24, 48, and 72 Hours After First Injection and Before Second Injection (Week 4)
timeFrame: After 24, 48, 72 hours of first Injection and before second injection (Week 4)
measure: Prurigo Activity Score (PAS) Item 5: Overall Number of Prurigo Lesions at Week 12
timeFrame: Baseline, Week 12
measure: Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit
timeFrame: Day 1 (Baseline), Weeks 4, 8, 12 and 18
measure: Investigator Global Assessment (IGA) Score at Each Visit
timeFrame: Day 1 (Baseline), Weeks 4, 8, 12 and 18
measure: 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
timeFrame: Week 12
Other outcomes:
Locations:
city: Graz
country: Austria
facility: LKH-Univ. Klinikum Graz
city: Brest
country: France
facility: Centre-Hospitalier Universitaire (CHU) - Hopital Morvan - Br
city: Nice
country: France
facility: CHU de Nice - Hôpital Archet 2
city: Paris
country: France
facility: Hopital Saint-Louis - Dermatology
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire De Toulouse
city: Berlin
country: Germany
facility: Charite - Campus Charite Mitte (CCM) - Dermatologie & Allergologie - Dermatologie & Allergologie
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn AöR
city: Frankfurt
country: Germany
facility: Klinikum der Johann-Wolfgang Goethe-Universität
city: Lubeck
country: Germany
facility: Unikl. Schleswig-Holstein - Lübeck
city: Mainz
country: Germany
facility: Universitätsmedizin Mainz
city: München
country: Germany
facility: Klinikum Der Universität München - Campus Innenstadt - Dermatologie und Allergologie
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Tuebingen
country: Germany
facility: Eberhard-Karls Universitaet Tuebingen - Universitaets Hautkl
city: Rzeszów
country: Poland
facility: Kliniczny Szpital Wojew. nr 1 im. F.Chopina w Rzeszowie
city: Łódź
country: Poland
facility: Centrum Medyczne DERMED
city: Łódź
country: Poland
facility: Dermoklinika Centrum Medyczne s.c. M.Kierstan, J.Narbutt, A.Lesiak
Study officials:
References:
citation: 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.