Study of Dupilumab for the Treatment of Patients With Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable (LIBERTY-PN PRIME)

NCT04183335 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: EFC164592019-003774-41U1111-1241-8153
• Study Type: interventional
• Target: 151
• Locations: 8 countries
• Sites: 63

Brief Summary

Primary Objective: To demonstrate the efficacy of dupilumab on itch response in participants with prurigo nodularis (PN), inadequately controlled on topical prescription therapies or when those therapies are not advisable. Secondary Objectives: To demonstrate the efficacy of dupilumab on additional itch endpoints in participants with PN, inadequately controlled on topical prescription therapies or when those therapies are not advisable. To demonstrate efficacy of dupilumab on skin lesions of PN. To demonstrate the improvement in health-related quality of life. To evaluate safety outcome measures. To evaluate immunogenicity of dupilumab.

Conditions

Neurodermatitis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Improvement (Reduction) in Worst Itch Numeric Rating Scale (WI-NRS) Scores by Greater Than or Equal to (>=) 4 Points From Baseline to Week 24

  WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity. Percentage of participants with improvement (reduction) in WI-NRS scores by \>=4 points from Baseline to Week 24 is reported in this outcome measure.

  Baseline, Week 24

Secondary Outcomes (20)

• Percentage of Participants With Investigator's Global Assessment For Prurigo Nodularis-Stage (IGA PN-S) Scores of 0 or 1 at Week 24

  At Week 24

• Percentage of Participants With Both an Improvement (Reduction) in WI-NRS Scores by >=4 Points and an IGA PN-S Scores of 0 or 1 From Baseline at Week 24

  Baseline, Week 24

• Percent Change From Baseline in WI-NRS Scores at Week 24

  Baseline, Week 24

• Change From Baseline in Health-Related Quality of Life (HRQoL) as Measured by Dermatology Life Quality Index (DLQI) at Week 24

  Baseline, Week 24

• Change From Baseline in Skin Pain-NRS at Week 24

  Baseline, Week 24

Study Arms (2)

Dupilumab

EXPERIMENTAL

Participants received dupilumab at a loading dose of 600 milligrams (mg), subcutaneously (SC) on Day 1 followed by dupilumab 300 mg once every 2 weeks (q2w) for 24 weeks added to background therapy of topical corticosteroids/topical calcineurin inhibitors (TCS/TCI) at stable dose.

Drug: Dupilumab SAR231893; Drug: Moisturizers; Drug: Low to medium potent topical corticosteroids; Drug: Topical calcineurin inhibitors

Placebo

PLACEBO COMPARATOR

Participants received placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose.

Drug: Placebo; Drug: Moisturizers; Drug: Low to medium potent topical corticosteroids; Drug: Topical calcineurin inhibitors

Interventions

Dupilumab SAR231893 DRUG

Pharmaceutical form:Injection solution Route of administration: Subcutaneous

Dupilumab

Placebo DRUG

Pharmaceutical form:Injection solution Route of administration: Subcutaneous

Placebo

Moisturizers DRUG

Pharmaceutical form: Route of administration: Topical

Dupilumab; Placebo

Low to medium potent topical corticosteroids DRUG

Pharmaceutical form: Route of administration: Topical

Dupilumab; Placebo

Topical calcineurin inhibitors DRUG

Pharmaceutical form: Route of administration: Topical

Dupilumab; Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be 18 to 80 years of age, at the time of signing the informed consent.
• With a clinical diagnosis of PN defined by all of the following:
• Diagnosed by a dermatologist for at least 3 months before the screening visit.
• On the worst-Itch Numeric Rating Scale (WI-NRS) ranged from 0 to 10, participants who had an average worst itch score of greater than or equal to (\>=) 7 in the 7 days prior to Day 1.
• Participants who had a minimum of 20 PN lesions in total on both legs, and/or both arms and/or trunk, at screening visit and Day 1.
• History of failing a 2-week course of medium-to-superpotent TCS or when TCS were not medically advisable.
• Had applied a stable dose of topical emollient (moisturizer) once or twice daily for at least 5 out of the 7 consecutive days immediately before Day 1.
• Was willing and abled to complete a daily symptom electronic-diary for the duration of the study.

You may not qualify if:

• Participants were excluded from the study if any of the following criteria apply:
• Presence of skin morbidities other than PN and mild atopic dermatitis (AD) that interfered with the assessment of the study outcomes.
• PN secondary to medications.
• PN secondary to medical conditions such as neuropathy or psychiatric disease.
• Within 6 months before the screening visit, or documented diagnosis of moderate to severe AD from screening visit to randomization visit.
• Severe concomitant illness(es) under poor control that, in the investigator's judgment, would adversely affect the participant's participation in the study.
• Severe renal conditions (eg, participants with uremia and/or on dialysis).
• Participants with uncontrolled thyroid disease.
• Active tuberculosis or non-tuberculous mycobacterial infection, or a history of incompletely treated tuberculosis unless documented adequately treated.
• Diagnosed active endoparasitic infections; suspected or high risk of endoparasitic infection, unless clinical and (if necessary) laboratory assessment had ruled out active infection before randomization.
• Active chronic or acute infection (except human immunodeficiency virus infection) required treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before the screening visit or during the screening period.
• Known or suspected immunodeficiency.
• Active malignancy or history of malignancy within 5 years before the baseline visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.
• The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (63)

Investigational Site Number :8400011

Gilbert, Arizona, 85234, United States

Location

Investigational Site Number :8400022

Fort Smith, Arkansas, 72916, United States

Location

Investigational Site Number :8400026

Sacramento, California, 95816, United States

Location

Investigational Site Number :8400014

Miami, Florida, 33136, United States

Location

Investigational Site Number :8400004

Columbus, Georgia, 31904, United States

Location

Investigational Site Number :8400003

Newnan, Georgia, 30263, United States

Location

Investigational Site Number :8400017

Sandy Springs, Georgia, 30328, United States

Location

Investigational Site Number :8400016

Indianapolis, Indiana, 46250, United States

Location

Investigational Site Number :8400018

Clarkston, Michigan, 48346, United States

Location

Investigational Site Number :8400013

St Louis, Missouri, 63110, United States

Location

Investigational Site Number :8400024

East Windsor, New Jersey, 08520, United States

Location

Investigational Site Number :8400009

Athens, Ohio, 45701, United States

Location

Investigational Site Number :8400001

Dublin, Ohio, 43016, United States

Location

Investigational Site Number :8400007

Tulsa, Oklahoma, 74136, United States

Location

Investigational Site Number :8400010

Philadelphia, Pennsylvania, 19104, United States

Location

Investigational Site Number :8400015

Charleston, South Carolina, 29414, United States

Location

Investigational Site Number :8400006

Bellaire, Texas, 77401, United States

Location

Investigational Site Number :8400025

Houston, Texas, 77058, United States

Location

Investigational Site Number :8400002

Pflugerville, Texas, 78660, United States

Location

Investigational Site Number :8400019

San Antonio, Texas, 78249, United States

Location

Investigational Site Number :8400005

Norfolk, Virginia, 23502, United States

Location

Investigational Site Number :0320008

CABA, Buenos Aires, C1023AAB, Argentina

Location

Investigational Site Number :0320005

CABA, Buenos Aires, C1055AAO, Argentina

Location

Investigational Site Number :0320002

CABA, Buenos Aires, C1425BEN, Argentina

Location

Investigational Site Number :0320004

CABA, Buenos Aires F.D., C1425BEA, Argentina

Location

Investigational Site Number :0320007

CABA, Buenos Aires F.D., C1431EKK, Argentina

Location

Investigational Site Number :0320003

San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina

Location

Investigational Site Number :0320001

Buenos Aires, C1121ABE, Argentina

Location

Investigational Site Number :0320006

Caba, 1425DES, Argentina

Location

Investigational Site Number :0320009

Mendoza, M5500, Argentina

Location

Investigational Site Number :1560004

Beijing, 100050, China

Location

Investigational Site Number :1560001

Chengdu, 610041, China

Location

Investigational Site Number :1560002

Hangzhou, 310006, China

Location

Investigational Site Number :1560003

Wuxi, 214002, China

Location

Investigational Site Number :2500005

Reims, 51100, France

Location

Investigational Site Number :3920009

Yokohama, Kanagawa, 236-0004, Japan

Location

Investigational Site Number :3920005

Kyoto, Kyoto, 606-8507, Japan

Location

Investigational Site Number :3920007

Nagasaki, Nagasaki, 852-8501, Japan

Location

Investigational Site Number :3920003

Tokorozawa-shi, Saitama, 359-8513, Japan

Location

Investigational Site Number :3920010

Izumo-shi, Shimane, 693-8501, Japan

Location

Investigational Site Number :3920004

Bunkyo-ku, Tokyo, 113-8519, Japan

Location

Investigational Site Number :3920006

Itabashi-ku, Tokyo, 173-8610, Japan

Location

Investigational Site Number :3920001

Shinagawa-Ku, Tokyo, 141-8625, Japan

Location

Investigational Site Number :3920002

Nagoya, 454-8509, Japan

Location

Investigational Site Number :4840002

Guadalajara, Jalisco, 44100, Mexico

Location

Investigational Site Number :4840001

Monterrey, Nuevo León, 64460, Mexico

Location

Investigational Site Number :4840005

Monterrey, Nuevo León, 64718, Mexico

Location

Investigational Site Number :4840006

Guadalajara, 44210, Mexico

Location

Investigational Site Number :4840003

Veracruz, 91910, Mexico

Location

Investigational Site Number :6430008

Chelyabinsk, 454048, Russia

Location

Investigational Site Number :6430007

Krasnodar, 350020, Russia

Location

Investigational Site Number :6430005

Moscow, 107076, Russia

Location

Investigational Site Number :6430010

Moscow, 115522, Russia

Location

Investigational Site Number :6430006

Moscow, 125993, Russia

Location

Investigational Site Number :6430002

Saint Petersburg, 197022, Russia

Location

Investigational Site Number :6430009

Saratov, 410026, Russia

Location

Investigational Site Number :6430001

Stavropol, 355030, Russia

Location

Investigational Site Number :4100007

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Investigational Site Number :4100005

Incheon, Incheon-gwangyeoksi, 21431, South Korea

Location

Investigational Site Number :4100002

Seoul, Seoul-teukbyeolsi, 03080, South Korea

Location

Investigational Site Number :4100003

Seoul, Seoul-teukbyeolsi, 03722, South Korea

Location

Investigational Site Number :4100004

Seoul, Seoul-teukbyeolsi, 07441, South Korea

Location

Investigational Site Number :4100001

Incheon, 21565, South Korea

Location

Related Publications (3)

• Kim BS, Goncalo M, Ugajin T, Gao XH, Praestgaard AH, Makhija M, Zahn J, Bansal A, Wiggins S. Efficacy and Safety of Dupilumab in Adults with Prurigo Nodularis with or Without Atopic Comorbidities: A Subgroup Analysis from Two Randomized Phase III Clinical Trials. Am J Clin Dermatol. 2026 Jan;27(1):167-180. doi: 10.1007/s40257-025-00993-1. Epub 2025 Nov 11.

  PMID: 41219577 DERIVED

• Kwatra SG, Yosipovitch G, Kim B, Stander S, Rhoten S, Ivanescu C, Haeusler N, Brookes E, Msihid J, Makhija M, Bansal A, Thomas RB, Bahloul D. Worst Itch Numeric Rating Scale for Prurigo Nodularis: A Secondary Analysis of 2 Randomized Clinical Trials. JAMA Dermatol. 2024 Aug 1;160(8):813-821. doi: 10.1001/jamadermatol.2024.1634.

  PMID: 38865146 DERIVED

• Yosipovitch G, Mollanazar N, Stander S, Kwatra SG, Kim BS, Laws E, Mannent LP, Amin N, Akinlade B, Staudinger HW, Patel N, Yancopoulos GD, Weinreich DM, Wang S, Shi G, Bansal A, O'Malley JT. Dupilumab in patients with prurigo nodularis: two randomized, double-blind, placebo-controlled phase 3 trials. Nat Med. 2023 May;29(5):1180-1190. doi: 10.1038/s41591-023-02320-9. Epub 2023 May 4.

  PMID: 37142763 DERIVED

Related Links

• EFC16459 Plain Language Results Summary

MeSH Terms

Conditions

Neurodermatitis

Interventions

dupilumab; Calcineurin Inhibitors

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Intervention Hierarchy (Ancestors)

Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi aventis recherche & développement

Contact-US@sanofi.com

800-633-1610

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2019
• First Posted: December 3, 2019
• Study Start: December 12, 2019
• Primary Completion: November 12, 2021
• Study Completion: February 3, 2022
• Last Updated: September 17, 2025
• Results First Posted: December 12, 2022

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

JP (9); ME (5); US (21); AR (9); FR (1); RU (8); CN (4); KR (6)