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

Last updated: November 4, 2024
Sponsor: Galderma R&D
Overall Status: Active - Not Recruiting

Phase

3

Condition

Warts

Eczema (Atopic Dermatitis - Pediatric)

Dermatitis, Atopic

Treatment

Nemolizumab

Clinical Study ID

NCT04204616
RD.06.SPR.202699
2019-004294-13
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Participants who may benefit from study participation in the opinion of theinvestigator 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 werepreviously 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 inthe LTE study within 28 days of exiting the durability study (selected countries/selected sites)

  • Female participants of childbearing potential (that is, fertile, following menarcheand until becoming post-menopausal unless permanently sterile) must agree either tobe strictly abstinent throughout the study and for 12 weeks after the last studydrug injection, or to use an adequate and approved method of contraceptionthroughout the study and for 12 weeks after the last study drug injection

  • Participant willing and able to comply with all of the time commitments andprocedural requirements of the clinical study protocol, including periodic weeklyrecordings by the participant using an electronic handheld device provided for thisstudy

  • Understand and sign an informed consent form (ICF) before any investigationalprocedure(s) are performed

Exclusion

Exclusion Criteria:

  • Participants who, during their participation in a prior nemolizumab study,experienced an adverse event (AE) which in the opinion of the investigator couldindicate that continued treatment with nemolizumab may present an unreasonable riskfor the participant

  • Body weight < 30 kg

  • Pregnant women (positive pregnancy test result at screening or baseline visit orre-entry Week R0 visit), breastfeeding women, or women planning a pregnancy duringthe clinical study

  • Any medical or psychological condition that may put the participant at significantrisk according to the investigator's judgment, if he/she participates in theclinical study, or may interfere with study assessments (example, poor venous accessor needle-phobia)

  • Planning or expected to have a major surgical procedure during the clinical study

  • Participants unwilling to refrain from using prohibited medications during theclinical study

  • History of alcohol or substance abuse within 6 months prior to the screening visitor re-entry Week R0 visit

Study Design

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: Nemolizumab
Phase: 3
Study Start date:
January 11, 2021
Estimated Completion Date:
October 26, 2026

Connect with a study center

  • Galderma Investigational Site

    Graz, 8036
    Austria

    Site Not Available

  • Galderma Investigational Site

    Linz, 4020
    Austria

    Site Not Available

  • Galderma Investigational Site

    Wien, 1220
    Austria

    Site Not Available

  • Galderma Investigational Site

    Brussels, 1200
    Belgium

    Site Not Available

  • Galderma Investigational Site

    Ghent, 9000
    Belgium

    Site Not Available

  • Galderma Investigational Site

    Jette, 1090
    Belgium

    Site Not Available

  • Galderma Investigational Site

    Leuven, 3000
    Belgium

    Site Not Available

  • Galderma Investigational Site

    Liège, 4000
    Belgium

    Site Not Available

  • Galderma Investigational Site

    London, Ontario N6A 3H7
    Canada

    Site Not Available

  • Galderma Investigational Site

    North York, Ontario M2M 4J5
    Canada

    Site Not Available

  • Galderma Investigational Site

    Saskatoon, Saskatchewan S7K OH6
    Canada

    Site Not Available

  • Galderma Investigational Site

    Bathurst, M3H 5Y8
    Canada

    Site Not Available

  • Galderma Investigational Site

    Calgary, T2G 1B1
    Canada

    Site Not Available

  • Galderma Investigational Site

    Drummondville, J2B 5L4
    Canada

    Site Not Available

  • Galderma Investigational Site

    Markham, L3P 1X2
    Canada

    Site Not Available

  • Galderma Investigational Site

    Toronto, M3H 5Y8
    Canada

    Site Not Available

  • Galderma Investigational Site

    Aarhus, 8200
    Denmark

    Site Not Available

  • Galderma Investigational Site

    Copenhagen, 2400
    Denmark

    Site Not Available

  • Galderma Investigational Site

    Hellerup, 2900
    Denmark

    Site Not Available

  • Galderma Investigational Site

    Bordeaux, 33000
    France

    Site Not Available

  • Galderma Investigational Site

    Brest, 29200
    France

    Site Not Available

  • Galderma Investigational Site

    Lyon, 69495
    France

    Site Not Available

  • Galderma Investigational Site

    Nantes, 44093
    France

    Site Not Available

  • Galderma Investigational Site

    Nice, 06202
    France

    Site Not Available

  • Galderma Investigational Site

    Paris, 75020
    France

    Site Not Available

  • Galderma Investigational Site

    Pierre-Bénite, 69495
    France

    Site Not Available

  • Galderma Investigational Site

    Quimper, 29107
    France

    Site Not Available

  • Galderma Investigational Site

    Rouen, 76000
    France

    Site Not Available

  • Galderma Investigational Site

    Saint-Étienne, 42055
    France

    Site Not Available

  • Galderma Investigational Site

    Toulouse, 31000
    France

    Site Not Available

  • Galderma Investigational Site

    Valence, 26953
    France

    Site Not Available

  • Galderma Investigational Site

    Aachen, 52074
    Germany

    Site Not Available

  • Galderma Investigational Site

    Augsburg, 86179
    Germany

    Site Not Available

  • Galderma Investigational Site

    Bad Bentheim, 48455
    Germany

    Site Not Available

  • Galderme Investigational Site

    Berlin, 10117
    Germany

    Site Not Available

  • Galderma Investigational Site

    Bonn, 53105
    Germany

    Site Not Available

  • Galderma Investigational Site

    Darmstadt, 64297
    Germany

    Site Not Available

  • Galderma Investigational Site

    Dresden, 01307
    Germany

    Site Not Available

  • Galderma Investigational Site

    Düsseldorf, 40225
    Germany

    Site Not Available

  • Galderma Investigational Site

    Eppendorf, 20246
    Germany

    Site Not Available

  • Galderma Investigational Site

    Göttingen, 37075
    Germany

    Site Not Available

  • Galderma Investigational Site

    Halle, 06120
    Germany

    Site Not Available

  • Galderma Investigational Site

    Hamburg, 20251
    Germany

    Site Not Available

  • Galderma Investigational Site

    Heidelberg, 69115
    Germany

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  • Galderma Investigational Site

    Kiel, 24105
    Germany

    Site Not Available

  • Galderma Investigational Site

    Lübeck, 23538
    Germany

    Site Not Available

  • Galderma Investigational Site

    Mainz, 55131
    Germany

    Site Not Available

  • Galderma Investigational Site

    Münich, 80802
    Germany

    Site Not Available

  • Galderma Investigational Site

    Münster, 48149
    Germany

    Site Not Available

  • Galderma Investigational Site

    Tübingen, 72076
    Germany

    Site Not Available

  • Galderma Investigational Site

    Kecskemét, 6000
    Hungary

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  • Galderma Investigational Site

    Szeged, 6720
    Hungary

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  • Galderma Investigational Site

    Szolnok, 5000
    Hungary

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  • Galderma Investigational Site

    Catania, 95123
    Italy

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  • Galderma Investigational Site

    Chieti, 66100
    Italy

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  • Galderma Investigational Site

    Genova, 16132
    Italy

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  • Galderma Investigational Site

    L'Aquila, 67100
    Italy

    Site Not Available

  • Galderma Investigational Site

    Modena, 41124
    Italy

    Site Not Available

  • Galderma Investigational Site

    Napoli, 80131
    Italy

    Site Not Available

  • Galderma Investigational Site

    Parma, 43126
    Italy

    Site Not Available

  • Galderma Investigational Site

    Perugia, 06129
    Italy

    Site Not Available

  • Galderma Investigational Site

    Roma, 00144
    Italy

    Site Not Available

  • Galderma Investigational Site

    Vicenza, 36100
    Italy

    Site Not Available

  • Galderma Investigational Site

    Gyeonggi-do, 15355
    Korea, Republic of

    Site Not Available

  • Galderma Investigational Site

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • Galderma Investigational Site

    Groningen, 9700
    Netherlands

    Site Not Available

  • Galderma Investigational Site

    Utrecht, 3508
    Netherlands

    Site Not Available

  • Galderma Investigational Site

    Bydgoszcz, 85-065
    Poland

    Site Not Available

  • Galderma Investigational Site

    Chorzów, 41-500
    Poland

    Site Not Available

  • Galderma Investigational Site

    Częstochowa, 42-202
    Poland

    Site Not Available

  • Galderma Investigational Site

    Gdańsk, 80-382
    Poland

    Site Not Available

  • Galderma Investigational Site

    Gdynia, 81-537
    Poland

    Site Not Available

  • Galderma Investigational Site

    Katowice, 40-040
    Poland

    Site Not Available

  • Galderma Investigational Site

    Kraków, 31-559
    Poland

    Site Not Available

  • Galderma Investigational Site

    Lublin, 20-081
    Poland

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  • Galderma Investigational Site

    Olsztyn, 10-900
    Poland

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  • Galderma Investigational Site

    Ostrowiec Świętokrzyski, 27-400
    Poland

    Site Not Available

  • Galderma Investigational Site

    Poznań, 60-702
    Poland

    Site Not Available

  • Galderma Investigational Site

    Rzeszów, 35-055
    Poland

    Site Not Available

  • Galderma Investigational Site

    Szczecin, 71-434
    Poland

    Site Not Available

  • Galderma Investigational Site

    Warsaw, 02-758
    Poland

    Site Not Available

  • Galderma Investigational Site

    Warszawa, 01-192
    Poland

    Site Not Available

  • Galderma Investigational Site

    Wrocław, 50-566
    Poland

    Site Not Available

  • Galderma Investigational Site

    Łódź, 90-127
    Poland

    Site Not Available

  • Galderma Investigational Site

    Barcelona, 08041
    Spain

    Site Not Available

  • Galderma Investigational Site

    Las Palmas De Gran Canaria, 35019
    Spain

    Site Not Available

  • Galderma Investigational Site

    Solna, 17176
    Sweden

    Site Not Available

  • Galderma Investigational Site

    Stockholm, 11883
    Sweden

    Site Not Available

  • Galderma Investigational Site

    Bern, 3010
    Switzerland

    Site Not Available

  • Galderma Investigational Site

    Buochs, 6374
    Switzerland

    Site Not Available

  • Galderma Investigational Site

    Lausanne, 1011
    Switzerland

    Site Not Available

  • Galderma Investigational Site

    Obbürgen, 6363
    Switzerland

    Site Not Available

  • Galderma Investigational Site

    Saint Gallen, 9007
    Switzerland

    Site Not Available

  • Galderma Investigational Site

    Weinfelden, 8570
    Switzerland

    Site Not Available

  • Galderma Investigational Site

    Dudley, DY1 2HQ
    United Kingdom

    Site Not Available

  • Galderma Investigational Site

    Glasgow, G3 8SJ
    United Kingdom

    Site Not Available

  • Galderma Investigational Site

    London, SE1 9RT
    United Kingdom

    Site Not Available

  • Galderma Investigational Site

    Newcastle Upon Tyne, NE1 4LP
    United Kingdom

    Site Not Available

  • Galderma Investigational Site

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Galderma Investigational Site

    Scottsdale, Arizona 85258
    United States

    Site Not Available

  • Galderma Investigational Site

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Galderma Investigational Site

    Los Angeles, California 90045
    United States

    Site Not Available

  • Galderma Investigational Site

    San Diego, California 92130
    United States

    Site Not Available

  • Galderma Investigational Site

    Santa Monica, California 94404
    United States

    Site Not Available

  • Galderma Investigational Site

    Washington, District of Columbia 20037
    United States

    Site Not Available

  • Galderma Investigational Site

    Aventura, Florida 33180
    United States

    Site Not Available

  • Galderma Investigational Site

    Delray Beach, Florida 33484
    United States

    Site Not Available

  • Galderma Investigational Site

    Gainesville, Florida 32606
    United States

    Site Not Available

  • Galderma Investigational Site

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Galderma Investigational Site

    Largo, Florida 33770
    United States

    Site Not Available

  • Galderma Investigational Site

    Miami, Florida 33125
    United States

    Site Not Available

  • Galderma Investigational Site

    North Miami Beach, Florida 33162
    United States

    Site Not Available

  • Galderma Investigational Site

    Ormond Beach, Florida 32174
    United States

    Site Not Available

  • Galderma Investigational Site

    Pembroke Pines, Florida 33028
    United States

    Site Not Available

  • Galderma Investigational Site

    Tampa, Florida 33607
    United States

    Site Not Available

  • Galderma Investigational Galderma Investigational Site

    Columbus, Georgia 31904
    United States

    Site Not Available

  • Galderma Investigational Site

    Macon, Georgia 31217
    United States

    Site Not Available

  • Galderma Investigational Site

    Newnan, Georgia 30263
    United States

    Site Not Available

  • Galderma Investigational Galderma Investigational Site

    Chicago, Illinois 60613
    United States

    Site Not Available

  • Galderma Investigational Site

    Chicago, Illinois 60602
    United States

    Site Not Available

  • Galderma I Galderma Investigational Site

    Lake Bluff, Illinois 60044
    United States

    Site Not Available

  • Galderma Investigational Site

    Indianapolis, Indiana 46250
    United States

    Site Not Available

  • Galderma Investigational Site

    Topeka, Kansas 66614
    United States

    Site Not Available

  • Galderma Investigational Site

    Louisville, Kentucky 40241
    United States

    Site Not Available

  • Galderma Investigational Site

    Baltimore, Maryland 21231
    United States

    Site Not Available

  • Galderma Investigational Site

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • Galderma Investigational Site

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Galderma Investigational Site

    Saint Joseph, Michigan 49085
    United States

    Site Not Available

  • Galderma Investigational Site

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Galderma Investigational Site

    Henderson, Nevada 89052
    United States

    Site Not Available

  • Galderma Investigational Site

    Lebanon, New Hampshire 03766
    United States

    Site Not Available

  • Galderma Investigational Site

    West Orange, New Jersey 07052
    United States

    Site Not Available

  • Galderma Investigational Galderma Investigational Site

    New York, New York 10065
    United States

    Site Not Available

  • Galderma Investigational Site

    New York, New York 10021
    United States

    Site Not Available

  • Galderma Investigational Site

    High Point, North Carolina 27262
    United States

    Site Not Available

  • Galderma Investigational Site

    Raleigh, North Carolina 27617
    United States

    Site Not Available

  • Galderma Investigational Site

    Winston-Salem, North Carolina 27104
    United States

    Site Not Available

  • Galderma Investigational Site

    Cincinnati, Ohio 45627
    United States

    Site Not Available

  • Galderma Investigational Site

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Galderma Investigational Site

    Dublin, Ohio 43016
    United States

    Site Not Available

  • Galderma Investigational Site

    Philadelphia, Pennsylvania 19103
    United States

    Site Not Available

  • Galderma Investigational Site

    Anderson, South Carolina 29621
    United States

    Site Not Available

  • Galderma Investigational Site

    Knoxville, Tennessee 37909
    United States

    Site Not Available

  • Galderma Investigational Site

    Murfreesboro, Tennessee 37130
    United States

    Site Not Available

  • Galderma Investigational Galderma Investigational Site

    Austin, Texas 78738
    United States

    Site Not Available

  • Galderma Investigational Site

    Dallas, Texas 75230
    United States

    Site Not Available

  • Galderma Investigational Site

    Dripping Springs, Texas 78620
    United States

    Site Not Available

  • Galderma Investigational Site

    Houston, Texas 77401
    United States

    Site Not Available

  • Galderma Investigational Site

    Pflugerville, Texas 78660
    United States

    Site Not Available

  • Galderma Investigational Site

    Webster, Texas 77004
    United States

    Site Not Available

  • Galderma Investigational Site

    Salt Lake City, Utah 84117
    United States

    Site Not Available

  • Galderma Investigational Galderma Investigational Site

    Springville, Utah 84663
    United States

    Site Not Available

  • Galderma Investigational Site

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Galderma Investigational Site

    Lynchburg, Virginia 24501
    United States

    Site Not Available

  • Galderma Investigational Site

    Morgantown, West Virginia 26505
    United States

    Site Not Available

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