Clinical trial NCT04501679: A Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Subjects With Prurigo Nodularis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prurigo Nodularis
Keywords: Prurigo
Neurodermatitis
Pruritus
Skin diseases
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2020-08-06
Enrollment: 274
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 primary objective was 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.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of PN for at least 6 months with: Pruriginous nodular lesions on upper limbs, trunk, and/or lower limbs, at least 20 nodules on the entire body with a bilateral distribution and Investigator Global Assessment (IGA) score more than equal to (\>=) 3 (based on the IGA scale ranging from 0 to 4, in which 3 was moderate and 4 is severe) at both the screening and baseline visits
* Severe pruritus was defined as follows on the PP NRS:

  1. At the screening visit (Visit 1): PP NRS score was \>= 7.0 for the 24-hour period immediately preceding the screening visit.
  2. At the baseline visit (Visit 2): Mean of the daily intensity of the PP NRS score was \>= 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 adequate and approved method of contraception throughout the study and for 12 weeks after the last study drug injection

Exclusion Criteria:

* Body weight less than \< 30 kg
* Chronic pruritus resulting from another active condition other than PN, such as but not limited to scabies, lichen simplex chronicus, psoriasis, atopic dermatitis, contact dermatitis, acne, folliculitis, lichen planus, habitual picking/excoriation disorder, sporotrichosis, bullous autoimmune disease, end-stage renal disease, or cholestatic liver disease (example \[eg\] primary biliary cirrhosis) or diabetes mellitus or thyroid disease that is not adequately treated, as per standard of care
* 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
* Neuropathic and psychogenic pruritus such as but not limited to notalgia paresthetica, brachioradial pruritus, small fiber neuropathy, skin picking syndrome, or delusional parasitosis
* Requiring rescue therapy for PN during the screening period or expected to require rescue therapy within 4 weeks following the baseline visit
* 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

Primary outcomes:
measure: Number of Participants With an Improvement of Greater Than or Equal to (>=) 4 From Baseline in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16
timeFrame: Baseline, Week 16
measure: Number of Participants With an Investigator Global Assessment (IGA) Success at Week 16
timeFrame: Baseline, Week 16
Secondary outcomes:
measure: Number of Participants With an Improvement of >= 4 From Baseline in Weekly Average PP NRS at Week 4
timeFrame: Baseline, Week 4
measure: Number of Participants With PP NRS < 2 at Week 16
timeFrame: Week 16
measure: Number of Participants With an Improvement of >=4 From Baseline in Sleep Disturbance Numeric Rating Scale (SD NRS) at Week 16
timeFrame: Baseline, Week 16
measure: Number of Participants With an Improvement of >=4 From Baseline in SD NRS at Week 4
timeFrame: Baseline, Week 4
measure: Number of Participants With PP NRS < 2 at Week 4
timeFrame: Week 4
measure: Number of Participants With Adverse Events, Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs)
timeFrame: From baseline up to end of treatment period (16 Weeks)
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: Galderma Investigational Site
state: California
city: San Diego
country: United States
facility: Galderma Investigational Site
state: California
city: Washington
country: United States
facility: Galderma Investigational Site
state: District of Columbia
city: Aventura
country: United States
facility: Galderma Investigational Site
state: Florida
city: Miami
country: United States
facility: Galderma Investigational Site
state: Florida
city: North Miami Beach
country: United States
facility: Galderma Investigational Site
state: Florida
city: Ormond Beach
country: United States
facility: Galderma Investigational Site
state: Florida
city: Chicago
country: United States
facility: Galderma Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: Galderma Investigational Site
state: Indiana
city: Louisville
country: United States
facility: Galderma Investigational Site
state: Kentucky
city: Boston
country: United States
facility: Galderma Investigational Site
state: Massachusetts
city: Saint Joseph
country: United States
facility: Galderma Investigational Site
state: Michigan
city: New York
country: United States
facility: Galderma Investigational Site
state: New York
city: Cincinnati
country: United States
facility: Galderma Investigational Site
state: Ohio
city: Dublin
country: United States
facility: Galderma Investigational Site
state: Ohio
city: Anderson
country: United States
facility: Galderma Investigational Site
state: South Carolina
city: Murfreesboro
country: United States
facility: Galderma Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Galderma Investigational Site
state: Texas
city: Dripping Springs
country: United States
facility: Galderma Investigational Site
state: Texas
city: Pflugerville
country: United States
facility: Galderma Investigational Site
state: Texas
city: Webster
country: United States
facility: Galderma Investigational Site
state: Texas
city: Morgantown
country: United States
facility: Galderma Investigational Site
state: West Virginia
city: Brussel
country: Belgium
facility: Galderma Investigational Site
city: Ghent
country: Belgium
facility: Galderma Investigational Site
city: Jette
country: Belgium
facility: Galderma Investigational Site
city: Leuven
country: Belgium
facility: Galderma Investigational Site
city: Liège
country: Belgium
facility: Galderma Investigational Site
city: North York
country: Canada
facility: Galderma Investigational Site
state: Ontario
city: Bathurst
country: Canada
facility: Galderma Investigational Site
city: Calgary
country: Canada
facility: Galderma Investigational Site
city: London
country: Canada
facility: Galderma Investigational Site
city: Markham
country: Canada
facility: Galderma Investigational Site
city: Bordeaux
country: France
facility: Galderma Investigational Site
city: Brest
country: France
facility: Galderma Investigational Site
city: Lille
country: France
facility: Galderma Investigational Site
city: Nantes
country: France
facility: Galderma Investigational Site
city: Nice
country: France
facility: Galderma Investigational Site
city: Paris
country: France
facility: Galderma Investigational Site
city: Paris
country: France
facility: Galderma Investigational Site
city: Pierre-Bénite
country: France
facility: Galderma Investigational Site
city: Rouen
country: France
facility: Galderma Investigational Site
city: Saint-Étienne
country: France
facility: Galderma Investigational Site
city: Toulouse
country: France
facility: Galderma Investigational Site
city: Valence
country: France
facility: Galderma Investigational Site
city: Gyeonggi-do
country: Korea, Republic of
facility: Galderma Investigational Site
city: Seoul
country: Korea, Republic of
facility: Galderma Investigational Site
city: Seoul
country: Korea, Republic of
facility: Galderma Investigational Site
city: Seoul
country: Korea, Republic of
facility: Galderma Investigational Site
city: Seoul
country: Korea, Republic of
facility: Galderma Investigational Site
city: Groningen
country: Netherlands
facility: Galderma Investigational Site
city: Utrecht
country: Netherlands
facility: Galderma Investigational Site
city: Bydgoszcz
country: Poland
facility: Galderma Investigational Site
city: Chorzów
country: Poland
facility: Galderma Investigational Site
city: Kraków
country: Poland
facility: Galderma Investigational Site
city: Lublin
country: Poland
facility: Galderma Investigational Site
city: Olsztyn
country: Poland
facility: Galderma Investigational Site
city: Ostrowiec Świętokrzyski
country: Poland
facility: Galderma Investigational Site
city: Rzeszów
country: Poland
facility: Galderma Investigational Site
city: Szczecin
country: Poland
facility: Galderma Investigational Site
city: Warsaw
country: Poland
facility: Galderma Investigational Site
city: Warsaw
country: Poland
facility: Galderma Investigational Site
city: Warsaw
country: Poland
facility: Galderma Investigational Site
city: Warsaw
country: Poland
facility: Galderma Investigational Site
city: Wrocław
country: Poland
facility: Galderma Investigational Site
city: Wrocław
country: Poland
facility: Galderma Investigational Site
city: Łódź
country: Poland
facility: Galderma Investigational Site
city: Łódź
country: Poland
facility: Galderma Investigational Site
city: Barcelona
country: Spain
facility: Galderma Investigational Site
city: Las Palmas De Gran Canaria
country: Spain
facility: Galderma Investigational Site
city: Bern
country: Switzerland
facility: Galderma Investigational Site
city: Buochs
country: Switzerland
facility: Galderma Investigational Site
city: Lausanne
country: Switzerland
facility: Galderma Investigational Site
city: Saint Gallen
country: Switzerland
facility: Galderma Investigational Site
city: Weinfelden
country: Switzerland
facility: Galderma Investigational Site
Study officials:
References:
citation: Kwatra SG, Yosipovitch G, Legat FJ, Reich A, Paul C, Simon D, Naldi L, Lynde C, De Bruin-Weller MS, Nahm WK, Sauder M, Gharib R, Barbarot S, Szepietowski JC, Conrad C, Fleischer A, Laquer VT, Misery L, Serra-Baldrich E, Lapeere H, Ahmad F, Jabbar Lopez ZK, Piketty C, Stander S; OLYMPIA 2 Investigators. Phase 3 Trial of Nemolizumab in Patients with Prurigo Nodularis. N Engl J Med. 2023 Oct 26;389(17):1579-1589. doi: 10.1056/NEJMoa2301333.