Clinical trial NCT04501666: 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: 286
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.
* Participant was willing and able to comply with all of the time commitments and procedural requirements of the clinical study protocol, including daily diary recordings by the participant using an electronic handheld device provided for this study.

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 \[e.g.\] primary biliary cirrhosis) or diabetes mellitus or thyroid disease that is not adequately treated, as per standard of care.
* Unilateral lesions of prurigo (e.g., only one arm affected).
* History of or current confounding skin condition (e.g., 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 (e.g., 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 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 (24 weeks)
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
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Galderma Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Galderma Investigational Site
state: Alabama
city: Los Angeles
country: United States
facility: Galderma Investigational Site
state: California
city: Sacramento
country: United States
facility: Galderma Investigational Site
state: California
city: San Diego
country: United States
facility: Galderma Investigational Site
state: California
city: San Diego
country: United States
facility: Galderma Investigational Site
state: California
city: Santa Monica
country: United States
facility: Galderma Investigational Site
state: California
city: Delray Beach
country: United States
facility: Galderma Investigational Site
state: Florida
city: Hollywood
country: United States
facility: Galderma Investigational Site
state: Florida
city: Largo
country: United States
facility: Galderma Investigational Site
state: Florida
city: Miami
country: United States
facility: Galderma Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: Galderma Investigational Site
state: Florida
city: Tampa
country: United States
facility: Galderma Investigational Site
state: Florida
city: Columbus
country: United States
facility: Galderma Investigational Site
state: Georgia
city: Macon
country: United States
facility: Galderma Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Galderma Investigational Site
state: Illinois
city: Lake Bluff
country: United States
facility: Galderma Investigational Site
state: Illinois
city: Topeka
country: United States
facility: Galderma Investigational Site
state: Kansas
city: Baltimore
country: United States
facility: Galderma Investigational Site
state: Maryland
city: Ann Arbor
country: United States
facility: Galderma Investigational Site
state: Michigan
city: Saint Joseph
country: United States
facility: Galderma Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: Galderma Investigational Site
state: Missouri
city: New York
country: United States
facility: Galderma Investigational Site
state: New York
city: High Point
country: United States
facility: Galderma Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Galderma Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: Galderma Investigational Site
state: Ohio
city: Norman
country: United States
facility: Galderma Investigational Site
state: Oklahoma
city: Philadelphia
country: United States
facility: Galderma Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Galderma Investigational Site
state: Pennsylvania
city: Johnston
country: United States
facility: Galderma Investigational Site
state: Rhode Island
city: Providence
country: United States
facility: Galderma Investigational Site
state: Rhode Island
city: Knoxville
country: United States
facility: Galderma Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Galderma Investigational Site
state: Texas
city: Bellaire
country: United States
facility: Galderma Investigational Site
state: Texas
city: Laredo
country: United States
facility: Galderma Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Galderma Investigational Site
state: Utah
city: Springville
country: United States
facility: Galderma Investigational Site
state: Utah
city: Fairfax
country: United States
facility: Galderma Investigational Site
state: Virginia
city: Graz
country: Austria
facility: Galderma Investigational Site
city: Linz
country: Austria
facility: Galderma Investigational Site
city: Wien
country: Austria
facility: Galderma Investigational Site
city: Calgary
country: Canada
facility: Galderma Investigational Site
state: AL
city: London
country: Canada
facility: Galderma Investigational Site
state: Ontario
city: Saskatoon
country: Canada
facility: Galderma Investigational Site
state: Saskatchewan
city: Aarhus
country: Denmark
facility: Galderma Investigational Site
city: Hellerup
country: Denmark
facility: Galderma Investigational Site
city: Aachen
country: Germany
facility: Galderma Investigational Site
city: Augsburg
country: Germany
facility: Galderma Investigational Site
city: Bad Bentheim
country: Germany
facility: Galderma Investigational Site
city: Berlin
country: Germany
facility: Galderma Investigational Site
city: Bonn
country: Germany
facility: Galderma Investigational Site
city: Darmstadt
country: Germany
facility: Galderma Investigational Site
city: Dresden
country: Germany
facility: Galderma Investigational Site
city: Düsseldorf
country: Germany
facility: Galderma Investigational Site
city: Eppendorf
country: Germany
facility: Galderma Investigational Site
city: Erlangen
country: Germany
facility: Galderma Investigational Site
city: Göttingen
country: Germany
facility: Galderma Investigational Site
city: Halle
country: Germany
facility: Galderma Investigational Site
city: Hamburg
country: Germany
facility: Galderma Investigational Site
city: Heidelberg
country: Germany
facility: Galderma Investigational Site
city: Kiel
country: Germany
facility: Galderma Investigational Site
city: Lübeck
country: Germany
facility: Galderma Investigational Site
city: Mainz
country: Germany
facility: Galderma Investigational Site
city: Münich
country: Germany
facility: Galderma Investigational Site
city: Münich
country: Germany
facility: Galderma Investigational Site
city: Münster
country: Germany
facility: Galderma Investigational Site
city: Oldenburg
country: Germany
facility: Galderma Investigational Site
city: Tübingen
country: Germany
facility: Galderma Investigational Site
city: Würzburg
country: Germany
facility: Galderma Investigational Site
city: Budapest
country: Hungary
facility: Galderma Investigational Site
city: Gyula
country: Hungary
facility: Galderma Investigational Site
city: Kecskemét
country: Hungary
facility: Galderma Investigational Site
city: Szeged
country: Hungary
facility: Galderma Investigational Site
city: Szolnok
country: Hungary
facility: Galderma Investigational Site
city: Zalaegerszeg
country: Hungary
facility: Galderma Investigational Site
city: Catania
country: Italy
facility: Galderma Investigational Site
city: Chieti
country: Italy
facility: Galderma Investigational Site
city: Genova
country: Italy
facility: Galderma Investigational Site
city: L'Aquila
country: Italy
facility: Galderma Investigational Site
city: Modena
country: Italy
facility: Galderma Investigational Site
city: Napoli
country: Italy
facility: Galderma Investigational Site
city: Parma
country: Italy
facility: Galderma Investigational Site
city: Perugia
country: Italy
facility: Galderma Investigational Site
city: Roma
country: Italy
facility: Galderma Investigational Site
city: Roma
country: Italy
facility: Galderma Investigational Site
city: Vicenza
country: Italy
facility: Galderma Investigational Site
city: Czestochowa
country: Poland
facility: Galderma Investigational Site
city: Gdańsk
country: Poland
facility: Galderma Investigational Site
city: Gdynia
country: Poland
facility: Galderma Investigational Site
city: Katowice
country: Poland
facility: Galderma Investigational Site
city: Poznań
country: Poland
facility: Galderma Investigational Site
city: Rzeszów
country: Poland
facility: Galderma Investigational Site
city: Warszawa
country: Poland
facility: Galderma Investigational Site
city: Wrocław
country: Poland
facility: Galderma Investigational Site
city: Łódź
country: Poland
facility: Galderma Investigational Site
city: Solna
country: Sweden
facility: Galderma Investigational Site
city: Dudley
country: United Kingdom
facility: Galderma Investigational Site
city: Glasgow
country: United Kingdom
facility: Galderma Investigational Site
city: London
country: United Kingdom
facility: Galderma Investigational Site
city: Newcastle Upon Tyne
country: United Kingdom
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.