A Long-term Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)

Prurigo Nodularis Clinical Trial

Official title:

A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects With Prurigo Nodularis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04204616
• Other study ID #: RD.06.SPR.202699
• Secondary ID: 2019-004294-13
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: January 11, 2021
• Est. completion date: October 26, 2026

Study information

• Verified date: September 2023
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 450
• Est. completion date: October 26, 2026
• Est. primary completion date: October 26, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)
• 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), 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

Related Conditions & MeSH terms

• Neurodermatitis
• Prurigo
• Prurigo Nodularis

Intervention

Drug:
• Nemolizumab
Nemolizumab 30 mg will be administered as subcutaneous (SC) injection.

Locations

Country	Name	City	State
Austria	Galderma Investigational Site	Graz
Austria	Galderma Investigational Site	Linz
Austria	Galderma Investigational Site	Wien
Belgium	Galderma Investigational Site	Brussels
Belgium	Galderma Investigational Site	Ghent
Belgium	Galderma Investigational Site	Jette
Belgium	Galderma Investigational Site	Leuven
Belgium	Galderma Investigational Site	Liège
Canada	Galderma Investigational Site	Calgary	AL
Canada	Galderma Investigational Site	Calgary
Canada	Galderma Investigational Site	London
Canada	Galderma Investigational Site	London	Ontario
Canada	Galderma Investigational Site	Markham
Canada	Galderma Investigational Site	North York	Ontario
Canada	Galderma Investigational Site	Saskatoon	Saskatchewan
Canada	Galderma Investigational Site	Toronto
Denmark	Galderma Investigational Site	Aarhus
Denmark	Galderma Investigational Site	Hellerup
France	Galderma Investigational Site	Bordeaux
France	Galderma Investigational Site	Brest
France	Galderma Investigational Site	Nantes
France	Galderma Investigational Site	Nice
France	Galderma Investigational Site	Paris
France	Galderma Investigational Site	Paris
France	Galderma Investigational Site	Pierre-Bénite
France	Galderma Investigational Site	Rouen
France	Galderma Investigational Site	Saint-Étienne
France	Galderma Investigational Site	Toulouse
France	Galderma Investigational Site	Valence
Germany	Galderma Investigational Site	Aachen
Germany	Galderma Investigational Site	Augsburg
Germany	Galderma Investigational Site	Bad Bentheim
Germany	Galderme Investigational Site	Berlin
Germany	Galderma Investigational Site	Bonn
Germany	Galderma Investigational Site	Darmstadt
Germany	Galderma Investigational Site	Dresden
Germany	Galderma Investigational Site	Düsseldorf
Germany	Galderma Investigational Site	Eppendorf
Germany	Galderma Investigational Site	Göttingen
Germany	Galderma Investigational Site	Halle
Germany	Galderma Investigational Site	Hamburg
Germany	Galderma Investigational Site	Heidelberg
Germany	Galderma Investigational Site	Kiel
Germany	Galderma Investigational Site	Lübeck
Germany	Galderma Investigational Site	Mainz
Germany	Galderma Investigational Site	Münich
Germany	Galderma Investigational Site	Münich
Germany	Galderma Investigational Site	Münster
Germany	Galderma Investigational Site	Tübingen
Hungary	Galderma Investigational Site	Kecskemét
Hungary	Galderma Investigational Site	Szeged
Hungary	Galderma Investigational Site	Szolnok
Italy	Galderma Investigational Site	Catania
Italy	Galderma Investigational Site	Chieti
Italy	Galderma Investigational Site	Genova
Italy	Galderma Investigational Site	L'Aquila
Italy	Galderma Investigational Site	Modena
Italy	Galderma Investigational Site	Napoli
Italy	Galderma Investigational Site	Parma
Italy	Galderma Investigational Site	Perugia
Italy	Galderma Investigational Site	Roma
Italy	Galderma Investigational Site	Roma
Italy	Galderma Investigational Site	Vicenza
Korea, Republic of	Galderma Investigational Site	Gyeonggi-do
Korea, Republic of	Galderma Investigational Site	Seoul
Korea, Republic of	Galderma Investigational Site	Seoul
Korea, Republic of	Galderma Investigational Site	Seoul
Korea, Republic of	Galderma Investigational Site	Seoul
Netherlands	Galderma Investigational Site	Groningen
Netherlands	Galderma Investigational Site	Utrecht
Poland	Galderma Investigational Site	Bydgoszcz
Poland	Galderma Investigational Site	Chorzów
Poland	Galderma Investigational Site	Czestochowa
Poland	Galderma Investigational Site	Gdansk
Poland	Galderma Investigational Site	Gdynia
Poland	Galderma Investigational Site	Katowice
Poland	Galderma Investigational Site	Kraków
Poland	Galderma Investigational Site	Lódz
Poland	Galderma Investigational Site	Lódz
Poland	Galderma Investigational Site	Lódz
Poland	Galderma Investigational Site	Lublin
Poland	Galderma Investigational Site	Olsztyn
Poland	Galderma Investigational Site	Ostrowiec Swietokrzyski
Poland	Galderma Investigational Site	Poznan
Poland	Galderma Investigational Site	Rzeszów
Poland	Galderma Investigational Site	Szczecin
Poland	Galderma Investigational Site	Warsaw
Poland	Galderma Investigational Site	Warsaw
Poland	Galderma Investigational Site	Warsaw
Poland	Galderma Investigational Site	Warsaw
Poland	Galderma Investigational Site	Warszawa
Poland	Galderma Investigational Site	Wroclaw
Poland	Galderma Investigational Site	Wroclaw
Poland	Galderma Investigational Site	Wroclaw
Spain	Galderma Investigational Site	Barcelona
Spain	Galderma Investigational Site	Las Palmas De Gran Canaria
Sweden	Galderma Investigational Site	Solna
Switzerland	Galderma Investigational Site	Bern
Switzerland	Galderma Investigational Site	Buochs
Switzerland	Galderma Investigational Site	Lausanne
Switzerland	Galderma Investigational Site	Obbürgen
Switzerland	Galderma Investigational Site	Saint Gallen
Switzerland	Galderma Investigational Site	Weinfelden
United Kingdom	Galderma Investigational Site	Dudley
United Kingdom	Galderma Investigational Site	Glasgow
United Kingdom	Galderma Investigational Site	London
United Kingdom	Galderma Investigational Site	Newcastle Upon Tyne
United States	Galderma Investigational Site	Anderson	South Carolina
United States	Galderma Investigational Site	Ann Arbor	Michigan
United States	Galderma Investigational Galderma Investigational Site	Austin	Texas
United States	Galderma Investigational Site	Aventura	Florida
United States	Galderma Investigational Site	Baltimore	Maryland
United States	Galderma Investigational Site	Birmingham	Alabama
United States	Galderma Investigational Site	Birmingham	Alabama
United States	Galderma Investigational Site	Boston	Massachusetts
United States	Galderma Investigational Galderma Investigational Site	Chicago	Illinois
United States	Galderma Investigational Site	Chicago	Illinois
United States	Galderma Investigational Site	Cincinnati	Ohio
United States	Galderma Investigational Site	Cleveland	Ohio
United States	Galderma Investigational Galderma Investigational Site	Columbus	Georgia
United States	Galderma Investigational Site	Dallas	Texas
United States	Galderma Investigational Site	Delray Beach	Florida
United States	Galderma Investigational Site	Dripping Springs	Texas
United States	Galderma Investigational Site	Dublin	Ohio
United States	Galderma Investigational Site	Fairfax	Virginia
United States	Galderma Investigational Site	Fountain Valley	California
United States	Galderma Investigational Site	Henderson	Nevada
United States	Galderma Investigational Site	High Point	North Carolina
United States	Galderma Investigational Site	Hollywood	Florida
United States	Galderma Investigational Site	Houston	Texas
United States	Galderma Investigational Site	Indianapolis	Indiana
United States	Galderma Investigational Site	Knoxville	Tennessee
United States	Galderma I Galderma Investigational Site	Lake Bluff	Illinois
United States	Galderma Investigational Site	Largo	Florida
United States	Galderma Investigational Site	Los Angeles	California
United States	Galderma Investigational Site	Louisville	Kentucky
United States	Galderma Investigational Site	Lynchburg	Virginia
United States	Galderma Investigational Site	Macon	Georgia
United States	Galderma Investigational Site	Miami	Florida
United States	Galderma Investigational Site	Miami	Florida
United States	Galderma Investigational Site	Morgantown	West Virginia
United States	Galderma Investigational Site	Murfreesboro	Tennessee
United States	Galderma Investigational Galderma Investigational Site	New York	New York
United States	Galderma Investigational Site	New York	New York
United States	Galderma Investigational Site	Newnan	Georgia
United States	Galderma Investigational Site	North Miami Beach	Florida
United States	Galderma Investigational Site	Ormond Beach	Florida
United States	Galderma Investigational Site	Pembroke Pines	Florida
United States	Galderma Investigational Site	Pflugerville	Texas
United States	Galderma Investigational Site	Philadelphia	Pennsylvania
United States	Galderma Investigational Site	Raleigh	North Carolina
United States	Galderma Investigational Site	Saint Joseph	Michigan
United States	Galderma Investigational Site	Saint Joseph	Missouri
United States	Galderma Investigational Site	Saint Louis	Missouri
United States	Galderma Investigational Site	Salt Lake City	Utah
United States	Galderma Investigational Site	San Diego	California
United States	Galderma Investigational Site	San Diego	California
United States	Galderma Investigational Site	Santa Monica	California
United States	Galderma Investigational Galderma Investigational Site	Springville	Utah
United States	Galderma Investigational Site	Tampa	Florida
United States	Galderma Investigational Site	Topeka	Kansas
United States	Galderma Investigational Site	Washington	District of Columbia
United States	Galderma Investigational Site	Webster	Texas
United States	Galderma Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  Denmark,  France,  Germany,  Hungary,  Italy,  Korea, Republic of,  Netherlands,  Poland,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events (AEs) by Severity	Incidence of AEs including AEs of Special Interest (AESIs), Treatment Emergent AEs (TEAEs) and Serious AEs (SAEs) by severity as mild, moderate or severe will be reported. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with relevant investigational product. SAE is any untoward medical occurrence that at any dose may results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. TEAE is an AE that occurs on or after the first date of study drug(s) administration until the date of last study visit. An AESI is a noteworthy treatment-emergent event for the study drug that should be monitored closely and reported promptly.	Up to 192 weeks
Secondary	Percentage of Participants with an Investigator Global Assessment (IGA) Success up to Week 184	Percentage of participants with an IGA success (defined as IGA of 0 [Clear] or 1 [Almost clear]) up to Week 184 will be reported.	Up to Week 184
Secondary	Percentage of Participants with an Improvement of >=4 from Baseline in Peak Pruritus (PP) Numeric Rating Scale (NRS) up to Week 184	Percentage of participants with an improvement of >= 4 from baseline in PP NRS up to Week 184 will be reported. The PP NRS has a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable".	Baseline up to Week 184
Secondary	Percentage of Participants with Low Disease Activity State up to Week 184	Percentage of participants with low disease activity state (that is, IGA <=2) up to Week 184 will be reported.	Up to Week 184
Secondary	Percentage of Pruriginous Lesions with Excoriations/Crusts up (PAS item 5a) up to Week 184	PAS will include a count of the number of lesions in a representative area and a calculated staging (stage 0 to stage 4) based on the percentage of lesions with excoriations/crusts and healed lesions compared to all lesions. PAS item 5a reflects the current itch/scratch activity. It is used to estimate what percentage of the pruriginous legions show excoriations/crusts. 100 percent (%) = All pruriginous lesions have excoriations/crusts. Percentage of pruriginous lesions with excoriations/crusts (PAS item 5a) up to Week 184 will be reported.	Up to Week 184
Secondary	Percentage of Healed Prurigo Lesions (PAS item 5b) up to Week 184	PAS item 5b item reflects the stage of the prurigo. It is used to estimate what percentage of the pruriginous lesions have healed.100% = all pruriginous lesions have healed. Percentage of healed prurigo lesions (PAS item 5b) up to Week 184 will be reported.	Up to Week 184
Secondary	Change from Baseline in Number of Lesions in Representative Area (PAS item 4) up to Week 184	Change from baseline in number of lesions in representative area (PAS item 4) up to Week 184 will be reported.	Baseline up to Week 184
Secondary	Percentage of Participants with PP NRS <2 up to Week 184	Percentage of participants with PP NRS <2 up to Week 184 will be reported. PP NRS is a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable".	Up to Week 184
Secondary	Percent Change from Baseline in PP NRS up to Week 184	Percent change from baseline in PP NRS up to Week 184 will be reported. PP NRS is a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable".	Baseline up to Week 184
Secondary	Absolute Change from Baseline in PP NRS up to Week 184	Absolute change from baseline in PP NRS up to Week 184 will be reported. PP NRS is a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable".	Baseline up to Week 184
Secondary	Percentage of Participants with Average Pruritus (AP) NRS <2 up to Week 52	Percentage of participants with AP NRS less than (<) 2 up to Week 52 will be reported. AP NRS has a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable".	Up to Week 52
Secondary	Percentage of Participants with an Improvement of >=4 from Baseline in AP NRS up to Week 52	Percentage of participants with an improvement of >=4 from baseline in AP NRS up to Week 52 will be reported. AP NRS has a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable".	Up to Week 52
Secondary	Percent Change from Baseline in AP NRS up to Week 52	Percent change from baseline in AP NRS up to Week 52 will be reported. AP NRS has a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable".	Up to Week 52
Secondary	Absolute Change from Baseline in AP NRS up to Week 52	Absolute change from baseline in AP NRS up to Week 52 will be reported. AP NRS has a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable".	Up to Week 52
Secondary	Percentage of Participants with an Improvement of >=4 from Baseline in Sleep Disturbance (SD) NRS up to Week 184	Percentage of participants with an improvement of >=4 from baseline in Sleep Disturbance (SD) NRS up to Week 184 will be reported. SD NRS has a scale of 0 to 10, with 0 being "no sleep loss related to the symptoms of my skin disease (prurigo nodularis)" and 10 being "I did not sleep at all due to the symptoms of my skin disease (prurigo nodularis)".	Up to Week 184
Secondary	Percent Change from Baseline in SD NRS up to Week 184	Percent change from baseline in SD NRS up to Week 184 will be reported. SD NRS has a scale of 0 to 10, with 0 being "no sleep loss related to the symptoms of my skin disease (prurigo nodularis)" and 10 being "I did not sleep at all due to the symptoms of my skin disease (prurigo nodularis)".	Up to Week 184
Secondary	Absolute Change from Baseline in SD NRS up to Week 184	Absolute change from baseline in SD NRS up to Week 184 will be reported. SD NRS has a scale of 0 to 10, with 0 being "no sleep loss related to the symptoms of my skin disease (prurigo nodularis)" and 10 being "I did not sleep at all due to the symptoms of my skin disease (prurigo nodularis)".	Up to Week 184
Secondary	Change from Baseline in Prurigo Nodularis (PN)-associated Pain Frequency up to Week 184	Change from baseline in PN-associated pain frequency up to Week 184 will be reported. The pain frequency will be assessed on a scale of 0 to 5 where 0 = never, 1 = less than once a week, 2 = 1-2 days a week, 3 = 3-4 days a week, and 4 = 5-6 days a week.	Baseline up to Week 184
Secondary	Change from Baseline in PN-associated Pain Intensity up to Week 184	Change from baseline in PN-associated pain intensity up to Week 184 will be reported. The pain intensity will be assessed on a scale of 0 to 10, with 0 being "no pain" and 10 being "the worst unbearable pain".	Baseline up to Week 184
Secondary	Percentage of Participants Reporting low Disease Activity Based on Patient Global Assessment of Disease (PGAD) up to Week 52	Percentage of participants reporting low disease activity (clear, almost clear, or mild) based on Patient Global Assessment of Disease (PGAD) up to Week 52 to be reported.	Up to Week 52
Secondary	Percentage of Participants Satisfied with Study Treatment Based on Patient Global Assessment of Treatment (PGAT) up to Week 52	Percentage of participants satisfied with study treatment (good, very good, or excellent) based on Patient Global Assessment of Treatment (PGAT) up to Week 52 will be reported.	Up to Week 52
Secondary	Percentage of Participants with a Change of >=4 from Baseline in Dermatology Life Quality Index (DLQI) up to Week 184	Percentage of participants with a change of >=4 from baseline in Dermatology Life Quality Index (DLQI) up to Week 184 will be reported. The DLQI is a validated 10-item questionnaire covering domains including symptoms/feelings, daily activities, leisure, work/school, personal relationships, and treatment. The participant will rate each question ranging from 0 (not at all) to 3 (very much). A higher total score indicates a poorer quality of life (QoL).	Baseline up to Week 184
Secondary	Change from Baseline in EuroQoL 5-Dimension (EQ-5D) up to Week 184	Change from baseline in EuroQoL 5-Dimension (EQ-5D) up to Week 184 will be reported. The EQ-5D instrument is a validated questionnaire, completed by the participant that consists of 2 parts. The first part consists of 5 multiple choice QoL questions and the second is a 100 point Visual Analog Scale (VAS) with 0 being "Worst imaginable health state" and 100 being "Best imaginable health state".	Baseline up to Week 184
Secondary	Time to Permanent Study Drug Discontinuation		Baseline to 184 weeks
Secondary	Time to Rescue Therapy		Baseline to 184 weeks
Secondary	Percentage of Participants Receiving Any Rescue Treatment by Rescue Treatment		Baseline up to 184 weeks