Clinical trial NCT04204616: A Long-term Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)
Official title: A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects With Prurigo Nodularis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Prurigo Nodularis
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2019-12-19
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to assess the long-term safety of nemolizumab (CD14152) in participants with prurigo nodularis (PN).


Eligibility criteria: Inclusion Criteria:

* Participants who may benefit from study participation in the opinion of the investigator and participated in a prior nemolizumab study for PN including: (a). Participants who completed the treatment period in a phase 3 pivotal study (NCT04501666 or NCT04501679) and enroll within 56 days OR (b). Participants who were previously randomized in the nemolizumab phase 2a PN study (NCT03181503) OR (c). Participants who completed through Week 24 of the phase 3b durability study (NCT05052983) or who exit the study due to relapse may be eligible to re-enter in the LTE study within 28 days of exiting the durability study (selected countries/ selected sites)
* Female participants of childbearing potential (that is, fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree either to be strictly abstinent throughout the study and for 12 weeks after the last study drug injection, or to use an adequate and approved method of contraception throughout the study and for 12 weeks after the last study drug injection
* Participant willing and able to comply with all of the time commitments and procedural requirements of the clinical study protocol, including periodic weekly recordings by the participant using an electronic handheld device provided for this study
* Understand and sign an informed consent form (ICF) before any investigational procedure(s) are performed

Exclusion Criteria:

* Participants who, during their participation in a prior nemolizumab study, experienced an adverse event (AE) which in the opinion of the investigator could indicate that continued treatment with nemolizumab may present an unreasonable risk for the participant
* Body weight \< 30 kg
* Pregnant women (positive pregnancy test result at screening or baseline visit or re-entry Week R0 visit), breastfeeding women, or women planning a pregnancy during the clinical study
* Any medical or psychological condition that may put the participant at significant risk according to the investigator's judgment, if he/she participates in the clinical study, or may interfere with study assessments (example, poor venous access or needle-phobia)
* Planning or expected to have a major surgical procedure during the clinical study
* Participants unwilling to refrain from using prohibited medications during the clinical study
* History of alcohol or substance abuse within 6 months prior to the screening visit or re-entry Week R0 visit

Primary outcomes:
measure: Incidence of Adverse Events (AEs) by Severity
timeFrame: Up to 192 weeks
Secondary outcomes:
measure: Percentage of Participants with an Investigator Global Assessment (IGA) Success up to Week 184
timeFrame: Up to Week 184
measure: Percentage of Participants with an Improvement of >=4 from Baseline in Peak Pruritus (PP) Numeric Rating Scale (NRS) up to Week 184
timeFrame: Baseline up to Week 184
measure: Percentage of Participants with Low Disease Activity State up to Week 184
timeFrame: Up to Week 184
measure: Percentage of Pruriginous Lesions with Excoriations/Crusts up (PAS item 5a) up to Week 184
timeFrame: Up to Week 184
measure: Percentage of Healed Prurigo Lesions (PAS item 5b) up to Week 184
timeFrame: Up to Week 184
measure: Change from Baseline in Number of Lesions in Representative Area (PAS item 4) up to Week 184
timeFrame: Baseline up to Week 184
measure: Percentage of Participants with PP NRS <2 up to Week 184
timeFrame: Up to Week 184
measure: Percent Change from Baseline in PP NRS up to Week 184
timeFrame: Baseline up to Week 184
measure: Absolute Change from Baseline in PP NRS up to Week 184
timeFrame: Baseline up to Week 184
measure: Percentage of Participants with Average Pruritus (AP) NRS <2 up to Week 52
timeFrame: Up to Week 52
measure: Percentage of Participants with an Improvement of >=4 from Baseline in AP NRS up to Week 52
timeFrame: Up to Week 52
measure: Percent Change from Baseline in AP NRS up to Week 52
timeFrame: Up to Week 52
measure: Absolute Change from Baseline in AP NRS up to Week 52
timeFrame: Up to Week 52
measure: Percentage of Participants with an Improvement of >=4 from Baseline in Sleep Disturbance (SD) NRS up to Week 184
timeFrame: Up to Week 184
measure: Percent Change from Baseline in SD NRS up to Week 184
timeFrame: Up to Week 184
measure: Absolute Change from Baseline in SD NRS up to Week 184
timeFrame: Up to Week 184
measure: Change from Baseline in Prurigo Nodularis (PN)-associated Pain Frequency up to Week 184
timeFrame: Baseline up to Week 184
measure: Change from Baseline in PN-associated Pain Intensity up to Week 184
timeFrame: Baseline up to Week 184
measure: Percentage of Participants Reporting low Disease Activity Based on Patient Global Assessment of Disease (PGAD) up to Week 52
timeFrame: Up to Week 52
measure: Percentage of Participants Satisfied with Study Treatment Based on Patient Global Assessment of Treatment (PGAT) up to Week 52
timeFrame: Up to Week 52
measure: Percentage of Participants with a Change of >=4 from Baseline in Dermatology Life Quality Index (DLQI) up to Week 184
timeFrame: Baseline up to Week 184
measure: Change from Baseline in EuroQoL 5-Dimension (EQ-5D) up to Week 184
timeFrame: Baseline up to Week 184
measure: Time to Permanent Study Drug Discontinuation
timeFrame: Baseline to 184 weeks
measure: Time to Rescue Therapy
timeFrame: Baseline to 184 weeks
measure: Percentage of Participants Receiving Any Rescue Treatment by Rescue Treatment
timeFrame: Baseline up to 184 weeks
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: Fountain Valley
country: United States
facility: Galderma Investigational Site
state: California
city: Los Angeles
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: Washington
country: United States
facility: Galderma Investigational Site
state: District of Columbia
city: Aventura
country: United States
facility: Galderma Investigational Site
state: Florida
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: 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: 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 Galderma Investigational Site
state: Georgia
city: Macon
country: United States
facility: Galderma Investigational Site
state: Georgia
city: Newnan
country: United States
facility: Galderma Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Galderma Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Galderma Investigational Galderma Investigational Site
state: Illinois
city: Lake Bluff
country: United States
facility: Galderma I Galderma Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: Galderma Investigational Site
state: Indiana
city: Topeka
country: United States
facility: Galderma Investigational Site
state: Kansas
city: Louisville
country: United States
facility: Galderma Investigational Site
state: Kentucky
city: Baltimore
country: United States
facility: Galderma Investigational Site
state: Maryland
city: Boston
country: United States
facility: Galderma Investigational Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Galderma Investigational Site
state: Michigan
city: Saint Joseph
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: Henderson
country: United States
facility: Galderma Investigational Site
state: Nevada
city: New York
country: United States
facility: Galderma Investigational Site
state: New York
city: New York
country: United States
facility: Galderma Investigational 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: Winston-Salem
country: United States
facility: Galderma Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Galderma Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: Galderma Investigational Site
state: Ohio
city: Dublin
country: United States
facility: Galderma Investigational Site
state: Ohio
city: Philadelphia
country: United States
facility: Galderma Investigational Site
state: Pennsylvania
city: Anderson
country: United States
facility: Galderma Investigational Site
state: South Carolina
city: Knoxville
country: United States
facility: Galderma Investigational Site
state: Tennessee
city: Murfreesboro
country: United States
facility: Galderma Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Galderma Investigational Galderma Investigational Site
state: Texas
city: Dallas
country: United States
facility: Galderma Investigational Site
state: Texas
city: Dripping Springs
country: United States
facility: Galderma Investigational Site
state: Texas
city: Houston
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: Salt Lake City
country: United States
facility: Galderma Investigational Site
state: Utah
city: Springville
country: United States
facility: Galderma Investigational Galderma Investigational Site
state: Utah
city: Fairfax
country: United States
facility: Galderma Investigational Site
state: Virginia
city: Lynchburg
country: United States
facility: Galderma Investigational Site
state: Virginia
city: Morgantown
country: United States
facility: Galderma Investigational Site
state: West 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: Brussels
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: Calgary
country: Canada
facility: Galderma Investigational Site
state: AL
city: London
country: Canada
facility: Galderma Investigational Site
state: Ontario
city: North York
country: Canada
facility: Galderma Investigational Site
state: Ontario
city: Saskatoon
country: Canada
facility: Galderma Investigational Site
state: Saskatchewan
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: Toronto
country: Canada
facility: Galderma Investigational Site
city: Aarhus
country: Denmark
facility: Galderma Investigational Site
city: Hellerup
country: Denmark
facility: Galderma Investigational Site
city: Bordeaux
country: France
facility: Galderma Investigational Site
city: Brest
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: 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: Galderme 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: 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: Tübingen
country: Germany
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: 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: 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: Częstochowa
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: 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: Poznań
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: Warszawa
country: Poland
facility: Galderma Investigational Site
city: Wrocław
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: 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: Solna
country: Sweden
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: Obbürgen
country: Switzerland
facility: Galderma Investigational Site
city: Saint Gallen
country: Switzerland
facility: Galderma Investigational Site
city: Weinfelden
country: Switzerland
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: