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

Recruitment Status
ACTIVE, NOT RECRUITING
(See Contacts and Locations)Verified October 2025 by Galderma R&D
Sponsor
Galderma R&D
Information Provided by (Responsible Party)
Galderma R&D
Clinicaltrials.gov Identifier
NCT04204616
Other Study ID Numbers:
RD.06.SPR.202699
First Submitted
December 16, 2019
First Posted
December 18, 2019
Last Update Posted
November 11, 2025
Last Verified
October 2025

ClinicalTrials.gov processed this data on November 2025Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Prurigo Nodularis
Drug: Nemolizumab

Study Design

Study TypeInterventional
Actual Enrollment500 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleA Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects With Prurigo Nodularis
Study Start DateJanuary 10, 2021
Actual Primary Completion Date5mos 2w from now
Actual Study Completion Date5mos 2w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Nemolizumab
Participants weighing less than (\<) 90kilogram (kg) will receive 30 milligram (mg) nemolizumab every 4 weeks (Q4W) and participants weighing greater than or equal to (\>=) 90 kg will receive 60 mg nemolizumab (two 30-mg injections) Q4W.
Drug: Nemolizumab
Nemolizumab 30 mg will be administered as subcutaneous (SC) injection.

Outcome Measures

Primary Outcome Measures
  1. 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.
Secondary Outcome Measures
  1. 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.
  2. 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 \&gt;= 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 &quot;no itch&quot; and 10 being &quot;worst itch imaginable&quot;.
  3. Percentage of Participants with Low Disease Activity State up to Week 184
    Percentage of participants with low disease activity state (that is, IGA less than or equal to \[\&lt;=\]2) up to Week 184 will be reported.
  4. Percentage of Pruriginous Lesions with Excoriations/Crusts up (PAS item 5a) up to Week 184
    Prurigo Activity Score (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.
  5. 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.
  6. 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.
  7. Percentage of Participants with PP NRS <2 up to Week 184
    Percentage of participants with PP NRS \&lt;2 up to Week 184 will be reported. PP NRS is a scale of 0 to 10, with 0 being &quot;no itch&quot; and 10 being &quot;worst itch imaginable&quot;.
  8. 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 &quot;no itch&quot; and 10 being &quot;worst itch imaginable&quot;.
  9. 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 &quot;no itch&quot; and 10 being &quot;worst itch imaginable&quot;.
  10. Percentage of Participants with Average Pruritus (AP) NRS <2 up to Week 52
    Percentage of participants with AP NRS less than (\&lt;) 2 up to Week 52 will be reported. AP NRS has a scale of 0 to 10, with 0 being &quot;no itch&quot; and 10 being &quot;worst itch imaginable&quot;.
  11. Percentage of Participants with an Improvement of >=4 from Baseline in AP NRS up to Week 52
    Percentage of participants with an improvement of \&gt;=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 &quot;no itch&quot; and 10 being &quot;worst itch imaginable&quot;.
  12. 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 &quot;no itch&quot; and 10 being &quot;worst itch imaginable&quot;.
  13. 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 &quot;no itch&quot; and 10 being &quot;worst itch imaginable&quot;.
  14. 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 \&gt;=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 &quot;no sleep loss related to the symptoms of my skin disease (prurigo nodularis)&quot; and 10 being &quot;I did not sleep at all due to the symptoms of my skin disease (prurigo nodularis)&quot;.
  15. 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 &quot;no sleep loss related to the symptoms of my skin disease (prurigo nodularis)&quot; and 10 being &quot;I did not sleep at all due to the symptoms of my skin disease (prurigo nodularis)&quot;.
  16. 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 &quot;no sleep loss related to the symptoms of my skin disease (prurigo nodularis)&quot; and 10 being &quot;I did not sleep at all due to the symptoms of my skin disease (prurigo nodularis)&quot;.
  17. 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.
  18. 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 &quot;no pain&quot; and 10 being &quot;the worst unbearable pain&quot;.
  19. 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.
  20. 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.
  21. 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 \&gt;=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).
  22. 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 &quot;Worst imaginable health state&quot; and 100 being &quot;Best imaginable health state&quot;.
  23. Time to Permanent Study Drug Discontinuation
  24. Time to Rescue Therapy
  25. Percentage of Participants Receiving Any Rescue Treatment by Rescue Treatment

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsGalderma R&D
Locations
Galderma Investigational Site | Birmingham Alabama, United States, 35233Galderma Investigational Site | Birmingham Alabama, United States, 35244Galderma Investigational Site | Fountain Valley California, United States, 92708Galderma Investigational Site | Los Angeles California, United States, 90045Galderma Investigational Site | San Diego California, United States, 92123Galderma Investigational Site | San Diego California, United States, 92130Galderma Investigational Site | Santa Monica California, United States, 94404Galderma Investigational Site | Washington D.C. District of Columbia, United States, 20037Galderma Investigational Site | Aventura Florida, United States, 33180Galderma Investigational Site | Delray Beach Florida, United States, 33484Galderma Investigational Site | Hollywood Florida, United States, 33021Galderma Investigational Site | Largo Florida, United States, 33770Galderma Investigational Site | Miami Florida, United States, 33125Galderma Investigational Site | Miami Florida, United States, 33136Galderma Investigational Site | North Miami Beach Florida, United States, 33162Galderma Investigational Site | Ormond Beach Florida, United States, 32174Galderma Investigational Site | Pembroke Pines Florida, United States, 33028Galderma Investigational Site | Tampa Florida, United States, 33607Galderma Investigational Galderma Investigational Site | Columbus Georgia, United States, 31904Galderma Investigational Site | Macon Georgia, United States, 31217Galderma Investigational Site | Newnan Georgia, United States, 30263Galderma Investigational Site | Chicago Illinois, United States, 60602Galderma Investigational Galderma Investigational Site | Chicago Illinois, United States, 60613Galderma I Galderma Investigational Site | Lake Bluff Illinois, United States, 60044Galderma Investigational Site | Indianapolis Indiana, United States, 46250Galderma Investigational Site | Topeka Kansas, United States, 66614Galderma Investigational Site | Louisville Kentucky, United States, 40241Galderma Investigational Site | Baltimore Maryland, United States, 21231Galderma Investigational Site | Boston Massachusetts, United States, 02111Galderma Investigational Site | Ann Arbor Michigan, United States, 48109Galderma Investigational Site | Saint Joseph Michigan, United States, 49085Galderma Investigational Site | Saint Joseph Missouri, United States, 64506Galderma Investigational Site | St Louis Missouri, United States, 63110Galderma Investigational Site | Henderson Nevada, United States, 89052Galderma Investigational Site | New York New York, United States, 10021Galderma Investigational Galderma Investigational Site | New York New York, United States, 10065Galderma Investigational Site | High Point North Carolina, United States, 27262Galderma Investigational Site | Raleigh North Carolina, United States, 27617Galderma Investigational Site | Winston-Salem North Carolina, United States, 27104Galderma Investigational Site | Cincinnati Ohio, United States, 45627Galderma Investigational Site | Cleveland Ohio, United States, 44106Galderma Investigational Site | Dublin Ohio, United States, 43016Galderma Investigational Site | Philadelphia Pennsylvania, United States, 19103Galderma Investigational Site | Anderson South Carolina, United States, 29621Galderma Investigational Site | Knoxville Tennessee, United States, 37909Galderma Investigational Site | Murfreesboro Tennessee, United States, 37130Galderma Investigational Galderma Investigational Site | Austin Texas, United States, 78738Galderma Investigational Site | Dallas Texas, United States, 75230Galderma Investigational Site | Dripping Springs Texas, United States, 78620Galderma Investigational Site | Houston Texas, United States, 77401Galderma Investigational Site | Pflugerville Texas, United States, 78660Galderma Investigational Site | Webster Texas, United States, 77004Galderma Investigational Site | Salt Lake City Utah, United States, 84117Galderma Investigational Galderma Investigational Site | Springville Utah, United States, 84663Galderma Investigational Site | Fairfax Virginia, United States, 22031Galderma Investigational Site | Lynchburg Virginia, United States, 24501Galderma Investigational Site | Morgantown West Virginia, United States, 26505Galderma Investigational Site | Graz , Austria, 8036Galderma Investigational Site | Linz , Austria, 4020Galderma Investigational Site | Vienna , Austria, 1220Galderma Investigational Site | Brussels , Belgium, 1200Galderma Investigational Site | Ghent , Belgium, 9000Galderma Investigational Site | Jette , Belgium, 1090Galderma Investigational Site | Leuven , Belgium, 3000Galderma Investigational Site | Liège , Belgium, 4000Galderma Investigational Site | Calgary AL, Canada, T3E OB2Galderma Investigational Site | London Ontario, Canada, N6A 3H7Galderma Investigational Site | North York Ontario, Canada, M2M 4J5Galderma Investigational Site | Saskatoon Saskatchewan, Canada, S7K OH6Galderma Investigational Site | Calgary , Canada, T2G 1B1Galderma Investigational Site | London , Canada, N6H 5L5Galderma Investigational Site | Markham , Canada, L3P 1X2Galderma Investigational Site | Toronto , Canada, M3H 5Y8Galderma Investigational Site | Aarhus , Denmark, 8200Galderma Investigational Site | Hellerup , Denmark, 2900Galderma Investigational Site | Bordeaux , France, 33000Galderma Investigational Site | Brest , France, 29200Galderma Investigational Site | Nantes , France, 44093Galderma Investigational Site | Nice , France, 06202Galderma Investigational Site | Paris , France, 75020Galderma Investigational Site | Paris , France, 75475Galderma Investigational Site | Pierre-Bénite , France, 69495Galderma Investigational Site | Rouen , France, 76000Galderma Investigational Site | Saint-Etienne , France, 42055Galderma Investigational Site | Toulouse , France, 31000Galderma Investigational Site | Valence , France, 26953Galderma Investigational Site | Aachen , Germany, 52074Galderma Investigational Site | Augsburg , Germany, 86179Galderma Investigational Site | Bad Bentheim , Germany, 48455Galderme Investigational Site | Berlin , Germany, 10117Galderma Investigational Site | Bonn , Germany, 53105Galderma Investigational Site | Darmstadt , Germany, 64297Galderma Investigational Site | Dresden , Germany, 01307Galderma Investigational Site | Düsseldorf , Germany, 40225Galderma Investigational Site | Eppendorf , Germany, 20246Galderma Investigational Site | Göttingen , Germany, 37075Galderma Investigational Site | Halle , Germany, 06120Galderma Investigational Site | Hamburg , Germany, 20251Galderma Investigational Site | Heidelberg , Germany, 69115Galderma Investigational Site | Kiel , Germany, 24105Galderma Investigational Site | Lübeck , Germany, 23538Galderma Investigational Site | Mainz , Germany, 55131Galderma Investigational Site | Münich , Germany, 80337Galderma Investigational Site | Münich , Germany, 80802Galderma Investigational Site | Münster , Germany, 48149Galderma Investigational Site | Tübingen , Germany, 72076Galderma Investigational Site | Kecskemét , Hungary, 6000Galderma Investigational Site | Szeged , Hungary, 6720Galderma Investigational Site | Szolnok , Hungary, 5000Galderma Investigational Site | Catania , Italy, 95123Galderma Investigational Site | Chieti , Italy, 66100Galderma Investigational Site | Genova , Italy, 16132Galderma Investigational Site | L’Aquila , Italy, 67100Galderma Investigational Site | Modena , Italy, 41124Galderma Investigational Site | Naples , Italy, 80131Galderma Investigational Site | Parma , Italy, 43126Galderma Investigational Site | Perugia , Italy, 06129Galderma Investigational Site | Roma , Italy, 00144Galderma Investigational Site | Roma , Italy, 00168Galderma Investigational Site | Vicenza , Italy, 36100Galderma Investigational Site | Groningen , Netherlands, 9700Galderma Investigational Site | Utrecht , Netherlands, 3508Galderma Investigational Site | Bydgoszcz , Poland, 85-065Galderma Investigational Site | Chorzów , Poland, 41-500Galderma Investigational Site | Częstochowa , Poland, 42-202Galderma Investigational Site | Gdansk , Poland, 80-382Galderma Investigational Site | Gdynia , Poland, 81-537Galderma Investigational Site | Katowice , Poland, 40-040Galderma Investigational Site | Krakow , Poland, 31-559Galderma Investigational Site | Lodz , Poland, 90-127Galderma Investigational Site | Lodz , Poland, 90-265Galderma Investigational Site | Lodz , Poland, 90-436Galderma Investigational Site | Lublin , Poland, 20-081Galderma Investigational Site | Olsztyn , Poland, 10-900Galderma Investigational Site | Ostrowiec Świętokrzyski , Poland, 27-400Galderma Investigational Site | Poznan , Poland, 60-702Galderma Investigational Site | Rzeszów , Poland, 35-055Galderma Investigational Site | Szczecin , Poland, 71-434Galderma Investigational Site | Warsaw , Poland, 01-192Galderma Investigational Site | Warsaw , Poland, 01-518Galderma Investigational Site | Warsaw , Poland, 01-817Galderma Investigational Site | Warsaw , Poland, 02-507Galderma Investigational Site | Warsaw , Poland, 02-758Galderma Investigational Site | Wroclaw , Poland, 50-381Galderma Investigational Site | Wroclaw , Poland, 50-566Galderma Investigational Site | Wroclaw , Poland, 51-318Galderma Investigational Site | Gyeonggi-do , South Korea, 15355Galderma Investigational Site | Seoul , South Korea, 02841Galderma Investigational Site | Seoul , South Korea, 03722Galderma Investigational Site | Seoul , South Korea, 04763Galderma Investigational Site | Seoul , South Korea, 07441Galderma Investigational Site | Barcelona , Spain, 08041Galderma Investigational Site | Las Palmas de Gran Canaria , Spain, 35019Galderma Investigational Site | Solna , Sweden, 17176Galderma Investigational Site | Bern , Switzerland, 3010Galderma Investigational Site | Buochs , Switzerland, 6374Galderma Investigational Site | Lausanne , Switzerland, 1011Galderma Investigational Site | Obbürgen , Switzerland, 6363Galderma Investigational Site | Sankt Gallen , Switzerland, 9007Galderma Investigational Site | Weinfelden , Switzerland, 8570Galderma Investigational Site | Dudley , United Kingdom, DY1 2HQGalderma Investigational Site | Glasgow , United Kingdom, G3 8SJGalderma Investigational Site | London , United Kingdom, SE1 9RTGalderma Investigational Site | Newcastle upon Tyne , United Kingdom, NE1 4LP