Prurigo NodularisPhase 3NCT04204616

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

A Phase 3 study testing Nemolizumab in people with Prurigo Nodularis, run by Galderma R&D at 164 sites in 16 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Prurigo Nodularis
What is being tested?: Nemolizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 500 participants
Where: 164 sitesin 16 countries
Study dates: 11 Jan 2021to 26 Oct 2026
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

164 sites in 16 countries.

Country

City, postcode or hospital

164 sites in 16 countries

United States57 sites

Galderma Investigational Site
Anderson, South Carolina, 29621
Galderma Investigational Site
Ann Arbor, Michigan, 48109
Galderma Investigational Galderma Investigational Site
Austin, Texas, 78738
Galderma Investigational Site
Aventura, Florida, 33180
Galderma Investigational Site
Baltimore, Maryland, 21231
Galderma Investigational Site
Birmingham, Alabama, 35233
Galderma Investigational Site
Birmingham, Alabama, 35244
Galderma Investigational Site
Boston, Massachusetts, 02111
Galderma Investigational Site
Chicago, Illinois, 60602
Galderma Investigational Galderma Investigational Site
Chicago, Illinois, 60613
Galderma Investigational Site
Cincinnati, Ohio, 45627
Galderma Investigational Site
Cleveland, Ohio, 44106
Galderma Investigational Galderma Investigational Site
Columbus, Georgia, 31904
Galderma Investigational Site
Dallas, Texas, 75230
Galderma Investigational Site
Delray Beach, Florida, 33484
Galderma Investigational Site
Dripping Springs, Texas, 78620
Galderma Investigational Site
Dublin, Ohio, 43016
Galderma Investigational Site
Fairfax, Virginia, 22031
Galderma Investigational Site
Fountain Valley, California, 92708
Galderma Investigational Site
Henderson, Nevada, 89052
Galderma Investigational Site
High Point, North Carolina, 27262
Galderma Investigational Site
Hollywood, Florida, 33021
Galderma Investigational Site
Houston, Texas, 77401
Galderma Investigational Site
Indianapolis, Indiana, 46250
Galderma Investigational Site
Knoxville, Tennessee, 37909
Galderma I Galderma Investigational Site
Lake Bluff, Illinois, 60044
Galderma Investigational Site
Largo, Florida, 33770
Galderma Investigational Site
Los Angeles, California, 90045
Galderma Investigational Site
Louisville, Kentucky, 40241
Galderma Investigational Site
Lynchburg, Virginia, 24501
Galderma Investigational Site
Macon, Georgia, 31217
Galderma Investigational Site
Miami, Florida, 33125
Galderma Investigational Site
Miami, Florida, 33136
Galderma Investigational Site
Morgantown, West Virginia, 26505
Galderma Investigational Site
Murfreesboro, Tennessee, 37130
Galderma Investigational Site
New York, New York, 10021
Galderma Investigational Galderma Investigational Site
New York, New York, 10065
Galderma Investigational Site
Newnan, Georgia, 30263
Galderma Investigational Site
North Miami Beach, Florida, 33162
Galderma Investigational Site
Ormond Beach, Florida, 32174
Galderma Investigational Site
Pembroke Pines, Florida, 33028
Galderma Investigational Site
Pflugerville, Texas, 78660
Galderma Investigational Site
Philadelphia, Pennsylvania, 19103
Galderma Investigational Site
Raleigh, North Carolina, 27617
Galderma Investigational Site
Saint Joseph, Michigan, 49085
Galderma Investigational Site
Saint Joseph, Missouri, 64506
Galderma Investigational Site
Salt Lake City, Utah, 84117
Galderma Investigational Site
San Diego, California, 92123
Galderma Investigational Site
San Diego, California, 92130
Galderma Investigational Site
Santa Monica, California, 94404
Galderma Investigational Galderma Investigational Site
Springville, Utah, 84663
Galderma Investigational Site
St Louis, Missouri, 63110
Galderma Investigational Site
Tampa, Florida, 33607
Galderma Investigational Site
Topeka, Kansas, 66614
Galderma Investigational Site
Washington D.C., District of Columbia, 20037
Galderma Investigational Site
Webster, Texas, 77004
Galderma Investigational Site
Winston-Salem, North Carolina, 27104

Other trials in United States

Poland24 sites

Galderma Investigational Site
Bydgoszcz, 85-065
Galderma Investigational Site
Chorzów, 41-500
Galderma Investigational Site
Częstochowa, 42-202
Galderma Investigational Site
Gdansk, 80-382
Galderma Investigational Site
Gdynia, 81-537
Galderma Investigational Site
Katowice, 40-040
Galderma Investigational Site
Krakow, 31-559
Galderma Investigational Site
Lodz, 90-127
Galderma Investigational Site
Lodz, 90-265
Galderma Investigational Site
Lodz, 90-436
Galderma Investigational Site
Lublin, 20-081
Galderma Investigational Site
Olsztyn, 10-900
Galderma Investigational Site
Ostrowiec Świętokrzyski, 27-400
Galderma Investigational Site
Poznan, 60-702
Galderma Investigational Site
Rzeszów, 35-055
Galderma Investigational Site
Szczecin, 71-434
Galderma Investigational Site
Warsaw, 01-192
Galderma Investigational Site
Warsaw, 01-518
Galderma Investigational Site
Warsaw, 01-817
Galderma Investigational Site
Warsaw, 02-507
Galderma Investigational Site
Warsaw, 02-758
Galderma Investigational Site
Wroclaw, 50-381
Galderma Investigational Site
Wroclaw, 50-566
Galderma Investigational Site
Wroclaw, 51-318

Other trials in Poland

Germany20 sites

Galderma Investigational Site
Aachen, 52074
Galderma Investigational Site
Augsburg, 86179
Galderma Investigational Site
Bad Bentheim, 48455
Galderme Investigational Site
Berlin, 10117
Galderma Investigational Site
Bonn, 53105
Galderma Investigational Site
Darmstadt, 64297
Galderma Investigational Site
Dresden, 01307
Galderma Investigational Site
Düsseldorf, 40225
Galderma Investigational Site
Eppendorf, 20246
Galderma Investigational Site
Göttingen, 37075
Galderma Investigational Site
Halle, 06120
Galderma Investigational Site
Hamburg, 20251
Galderma Investigational Site
Heidelberg, 69115
Galderma Investigational Site
Kiel, 24105
Galderma Investigational Site
Lübeck, 23538
Galderma Investigational Site
Mainz, 55131
Galderma Investigational Site
Münich, 80337
Galderma Investigational Site
Münich, 80802
Galderma Investigational Site
Münster, 48149
Galderma Investigational Site
Tübingen, 72076

Other trials in Germany

France11 sites

Galderma Investigational Site
Bordeaux, 33000
Galderma Investigational Site
Brest, 29200
Galderma Investigational Site
Nantes, 44093
Galderma Investigational Site
Nice, 06202
Galderma Investigational Site
Paris, 75020
Galderma Investigational Site
Paris, 75475
Galderma Investigational Site
Pierre-Bénite, 69495
Galderma Investigational Site
Rouen, 76000
Galderma Investigational Site
Saint-Etienne, 42055
Galderma Investigational Site
Toulouse, 31000
Galderma Investigational Site
Valence, 26953

Other trials in France

Italy11 sites

Galderma Investigational Site
Catania, 95123
Galderma Investigational Site
Chieti, 66100
Galderma Investigational Site
Genova, 16132
Galderma Investigational Site
L’Aquila, 67100
Galderma Investigational Site
Modena, 41124
Galderma Investigational Site
Naples, 80131
Galderma Investigational Site
Parma, 43126
Galderma Investigational Site
Perugia, 06129
Galderma Investigational Site
Roma, 00144
Galderma Investigational Site
Roma, 00168
Galderma Investigational Site
Vicenza, 36100

Other trials in Italy

Canada8 sites

Galderma Investigational Site
Calgary, AL, T3E OB2
Galderma Investigational Site
Calgary, T2G 1B1
Galderma Investigational Site
London, Ontario, N6A 3H7
Galderma Investigational Site
London, N6H 5L5
Galderma Investigational Site
Markham, L3P 1X2
Galderma Investigational Site
North York, Ontario, M2M 4J5
Galderma Investigational Site
Saskatoon, Saskatchewan, S7K OH6
Galderma Investigational Site
Toronto, M3H 5Y8

Other trials in Canada

Switzerland6 sites

Galderma Investigational Site
Bern, 3010
Galderma Investigational Site
Buochs, 6374
Galderma Investigational Site
Lausanne, 1011
Galderma Investigational Site
Obbürgen, 6363
Galderma Investigational Site
Sankt Gallen, 9007
Galderma Investigational Site
Weinfelden, 8570

Other trials in Switzerland

Belgium5 sites

Galderma Investigational Site
Brussels, 1200
Galderma Investigational Site
Ghent, 9000
Galderma Investigational Site
Jette, 1090
Galderma Investigational Site
Leuven, 3000
Galderma Investigational Site
Liège, 4000

Other trials in Belgium

South Korea5 sites

Galderma Investigational Site
Gyeonggi-do, 15355
Galderma Investigational Site
Seoul, 02841
Galderma Investigational Site
Seoul, 03722
Galderma Investigational Site
Seoul, 04763
Galderma Investigational Site
Seoul, 07441

Other trials in South Korea

United Kingdom4 sites

Galderma Investigational Site
Dudley, DY1 2HQ
Galderma Investigational Site
Glasgow, G3 8SJ
Galderma Investigational Site
London, SE1 9RT
Galderma Investigational Site
Newcastle upon Tyne, NE1 4LP

Other trials in United Kingdom

Austria3 sites

Galderma Investigational Site
Graz, 8036
Galderma Investigational Site
Linz, 4020
Galderma Investigational Site
Vienna, 1220

Other trials in Austria

Hungary3 sites

Galderma Investigational Site
Kecskemét, 6000
Galderma Investigational Site
Szeged, 6720
Galderma Investigational Site
Szolnok, 5000

Other trials in Hungary

Denmark2 sites

Galderma Investigational Site
Aarhus, 8200
Galderma Investigational Site
Hellerup, 2900

Other trials in Denmark

Netherlands2 sites

Galderma Investigational Site
Groningen, 9700
Galderma Investigational Site
Utrecht, 3508

Other trials in Netherlands

Spain2 sites

Galderma Investigational Site
Barcelona, 08041
Galderma Investigational Site
Las Palmas de Gran Canaria, 35019

Other trials in Spain

Sweden1 site

Galderma Investigational Site
Solna, 17176

Other trials in Sweden

About this study

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

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

Conditions: Prurigo Nodularis
Being tested: Nemolizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NemolizumabDrug
Also called CD14152
Nemolizumab 30 mg will be administered as subcutaneous (SC) injection.

Study groups in NCT04204616
Study group	Role	What they receive
Nemolizumab	Experimental	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. Receives: Drug: Nemolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to 192 weeks

Secondary outcomes (25)

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.
Measured: Up to Week 184
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".
Measured: Baseline up to Week 184
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 [<=]2) up to Week 184 will be reported.
Measured: Up to Week 184
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.
Measured: Up to Week 184
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.
Measured: Up to Week 184
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.
Measured: Baseline up to Week 184
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".
Measured: Up to Week 184
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".
Measured: Baseline up to Week 184
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".
Measured: Baseline up to Week 184
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".
Measured: Up to Week 52
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".
Measured: Up to Week 52
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".
Measured: Up to Week 52
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".
Measured: Up to Week 52
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)".
Measured: Up to Week 184
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)".
Measured: Up to Week 184
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)".
Measured: Up to Week 184
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.
Measured: Baseline up to Week 184
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".
Measured: Baseline up to Week 184
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.
Measured: Up to Week 52
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.
Measured: Up to Week 52
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).
Measured: Baseline up to Week 184
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".
Measured: Baseline up to Week 184
Time to Permanent Study Drug Discontinuation
Measured: Baseline to 184 weeks
Time to Rescue Therapy
Measured: Baseline to 184 weeks
Percentage of Participants Receiving Any Rescue Treatment by Rescue Treatment
Measured: Baseline up to 184 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jan 202126 Oct 2026

First posted19 Dec 2019
Study start11 Jan 2021
Primary completion26 Oct 2026 (estimated)
Study completion26 Oct 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Prurigo NodularisStudies of the same condition, open and under way.
More trials run by Galderma R&DThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 500 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04204616
Sponsor's protocol ID: RD.06.SPR.202699
Other IDs: 2019-004294-13, 2019
Status last verified: Nov 2025
First submitted: 17 Dec 2019
Last updated: 12 Nov 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Legat FJ, Kwatra SG, Reich A, Boulinguez S, Tsianakas A, Sauder M, Barbarot S, Szepietowski JC, Conrad C, Pink AE, Weisshaar E, Misery L, Metz M, Laquer VT, Sivamani RK, Yosipovitch G, Thaci D, Skov L, Chen X, Noda A, Jabbar-Lopez ZK, Piketty C, Stander S. Nemolizumab in prurigo nodularis up to 100 weeks: OLYMPIA LTE interim analysis. J Eur Acad Dermatol Venereol. 2026 Jul;40(7):1195-1207. doi: 10.1111/jdv.70266. Epub 2025 Dec 17.
PubMed 41405008

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Study to Evaluate the Efficacy and Safety of AK139 in Patients With Prurigo Nodularis.
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A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥6 Months to <18 Years of Age With Prurigo Nodularis
Prurigo Nodularis
RecruitingPhase 2
Study of the Efficacy and Safety of ICP-332 in Participants With Prurigo Nodularis
Prurigo Nodularis (PN)
RecruitingObservational study
Real-world Experience on Using Nemolizumab in the Treatment of Moderate-to- Severe Prurigo Nodularis in Adults
Prurigo Nodularis
Not yet recruitingPhase 2
Efficacy and Speed of Response of Lebrikizumab in High-Burden Prurigo Nodularis Patients
Prurigo Nodularis (PN)

All Prurigo Nodularis trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects With Prurigo Nodularis
ClinicalTrials.gov ID: NCT04204616
Acronym / sponsor ID: RD.06.SPR.202699
Conditions: Prurigo Nodularis
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 500 participants (estimated)
Lead sponsor: Galderma R&DIndustry (pharma, biotech, devices)
Study start: 11 Jan 2021 (actual)
Primary completion: 26 Oct 2026 (estimated)
Study completion: 26 Oct 2026 (estimated)
First posted: 19 Dec 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Nemolizumab	Experimental	Drug: NemolizumabParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NemolizumabAlso: CD14152Nemolizumab 30 mg will be administered as subcutaneous (SC) injection.	Drug	Nemolizumab

Primary outcome

Incidence of Adverse Events (AEs) by Severity
Time frame: Up to 192 weeks
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.

25 secondary outcomes

Percentage of Participants with an Investigator Global Assessment (IGA) Success up to Week 184
Time frame: Up to Week 184
Percentage of Participants with an Improvement of >=4 from Baseline in Peak Pruritus (PP) Numeric Rating Scale (NRS) up to Week 184
Time frame: Baseline up to Week 184
Percentage of Participants with Low Disease Activity State up to Week 184
Time frame: Up to Week 184
Percentage of Pruriginous Lesions with Excoriations/Crusts up (PAS item 5a) up to Week 184
Time frame: Up to Week 184
Percentage of Healed Prurigo Lesions (PAS item 5b) up to Week 184
Time frame: Up to Week 184
Change from Baseline in Number of Lesions in Representative Area (PAS item 4) up to Week 184
Time frame: Baseline up to Week 184
Percentage of Participants with PP NRS <2 up to Week 184
Time frame: Up to Week 184
Percent Change from Baseline in PP NRS up to Week 184
Time frame: Baseline up to Week 184
Absolute Change from Baseline in PP NRS up to Week 184
Time frame: Baseline up to Week 184
Percentage of Participants with Average Pruritus (AP) NRS <2 up to Week 52
Time frame: Up to Week 52
Percentage of Participants with an Improvement of >=4 from Baseline in AP NRS up to Week 52
Time frame: Up to Week 52
Percent Change from Baseline in AP NRS up to Week 52
Time frame: Up to Week 52
Absolute Change from Baseline in AP NRS up to Week 52
Time frame: Up to Week 52
Percentage of Participants with an Improvement of >=4 from Baseline in Sleep Disturbance (SD) NRS up to Week 184
Time frame: Up to Week 184
Percent Change from Baseline in SD NRS up to Week 184
Time frame: Up to Week 184
Absolute Change from Baseline in SD NRS up to Week 184
Time frame: Up to Week 184
Change from Baseline in Prurigo Nodularis (PN)-associated Pain Frequency up to Week 184
Time frame: Baseline up to Week 184
Change from Baseline in PN-associated Pain Intensity up to Week 184
Time frame: Baseline up to Week 184
Percentage of Participants Reporting low Disease Activity Based on Patient Global Assessment of Disease (PGAD) up to Week 52
Time frame: Up to Week 52
Percentage of Participants Satisfied with Study Treatment Based on Patient Global Assessment of Treatment (PGAT) up to Week 52
Time frame: Up to Week 52
Percentage of Participants with a Change of >=4 from Baseline in Dermatology Life Quality Index (DLQI) up to Week 184
Time frame: Baseline up to Week 184
Change from Baseline in EuroQoL 5-Dimension (EQ-5D) up to Week 184
Time frame: Baseline up to Week 184
Time to Permanent Study Drug Discontinuation
Time frame: Baseline to 184 weeks
Time to Rescue Therapy
Time frame: Baseline to 184 weeks
Percentage of Participants Receiving Any Rescue Treatment by Rescue Treatment
Time frame: Baseline up to 184 weeks

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2025.
Derived from this study: PubMed 41405008Legat FJ, Kwatra SG, Reich A, Boulinguez S, Tsianakas A, Sauder M, Barbarot S, Szepietowski JC, Conrad C, Pink AE, Weisshaar E, Misery L, Metz M, Laquer VT, Sivamani RK, Yosipovitch G, Thaci D, Skov L, Chen X, Noda A, Jabbar-Lopez ZK, Piketty C, Stander S. Nemolizumab in prurigo nodularis up to 100 weeks: OLYMPIA LTE interim analysis. J Eur Acad Dermatol Venereol. 2026 Jul;40(7):1195-1207. doi: 10.1111/jdv.70266. Epub 2025 Dec 17.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

164 sites in 16 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nemolizumab in people with Prurigo Nodularis, run by Galderma R&D at 164 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 12 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 164 sites in United States, Poland, Germany, France, Italy and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events (AEs) by Severity (time frame: Up to 192 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04204616, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2025.