Study of Dupilumab for the Treatment of Patients With Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable (PRIME2)

NCT ID: NCT04202679

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-16
• Study Completion Date: 2021-11-22

Brief Summary

Primary Objective:

To demonstrate the efficacy of dupilumab on itch response in participants with prurigo nodularis (PN), inadequately controlled on topical prescription therapy 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 therapy 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.

Detailed Description

The duration of study for each participant included 2-4 weeks of screening period, 24 weeks of treatment period and 12 weeks of post treatment period.

Conditions

Neurodermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Participants received placebo matched to dupilumab 600 milligrams (mg) (loading dose), subcutaneously (SC) on Day 1 followed by placebo matched to 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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Pharmaceutical form:Injection solution Route of administration: Subcutaneous

Moisturizers

Intervention Type: DRUG

Pharmaceutical form:

Route of administration: Topical

Low to medium potent topical corticosteroids

Intervention Type: DRUG

Pharmaceutical form:

Route of administration: Topical

Topical calcineurin inhibitors

Intervention Type: DRUG

Pharmaceutical form:

Route of administration: Topical

Dupilumab 300 mg Q2W

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

Group Type: EXPERIMENTAL

Dupilumab SAR231893

Intervention Type: DRUG

Pharmaceutical form:Injection solution Route of administration: Subcutaneous

Moisturizers

Intervention Type: DRUG

Pharmaceutical form:

Route of administration: Topical

Low to medium potent topical corticosteroids

Intervention Type: DRUG

Pharmaceutical form:

Route of administration: Topical

Topical calcineurin inhibitors

Intervention Type: DRUG

Pharmaceutical form:

Route of administration: Topical

Interventions

Dupilumab SAR231893

Pharmaceutical form:Injection solution Route of administration: Subcutaneous

Intervention Type: DRUG

Placebo

Pharmaceutical form:Injection solution Route of administration: Subcutaneous

Intervention Type: DRUG

Moisturizers

Pharmaceutical form:

Route of administration: Topical

Intervention Type: DRUG

Low to medium potent topical corticosteroids

Pharmaceutical form:

Route of administration: Topical

Intervention Type: DRUG

Topical calcineurin inhibitors

Pharmaceutical form:

Route of administration: Topical

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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) ranging from 0 to 10, participants must have an average worst itch score of >=7 in the 7 days prior to Day1.
• Participants must have 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 topical corticosteroids (TCS) or when TCS are not medically advisable
• Have 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.

Must be willing and able to complete a daily symptom eDiary for the duration of the study.

Exclusion Criteria

Participants were excluded from the study if any of the following criteria apply:

• Presence of skin morbidities other than PN and mild atopic dermatitis that may interfere 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 atopic dermatitis 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 have ruled out active infection before randomization.
• Active chronic or acute infection (except HIV) requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before the screening visit and 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number :8400054

Fort Smith, Arkansas, United States

Investigational Site Number :8400008

Sacramento, California, United States

Investigational Site Number :8400005

Pembroke Pines, Florida, United States

Investigational Site Number :8400002

Plainfield, Indiana, United States

Investigational Site Number :8400003

Baltimore, Maryland, United States

Investigational Site Number :8400006

East Windsor, New Jersey, United States

Investigational Site Number :8400001

Sugar Land, Texas, United States

Investigational Site Number :1240002

Calgary, Alberta, Canada

Investigational Site Number :1240006

Surrey, British Columbia, Canada

Investigational Site Number :1240007

Markham, Ontario, Canada

Investigational Site Number :1240008

Newmarket, Ontario, Canada

Investigational Site Number :1240001

Toronto, Ontario, Canada

Investigational Site Number :1240009

Saskatoon, Saskatchewan, Canada

Investigational Site Number :1520005

Valdivia, Los Ríos Region, Chile

Investigational Site Number :1520006

Osorno, Reg Metropolitana de Santiago, Chile

Investigational Site Number :1520003

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number :1520001

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number :1520004

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number :1520002

Santiago, , Chile

Investigational Site Number :2500007

Bordeaux, , France

Investigational Site Number :2500001

Brest, , France

Investigational Site Number :2500008

Le Mans, , France

Investigational Site Number :2500002

Lille, , France

Investigational Site Number :2500006

Lyon, , France

Investigational Site Number :2500004

Paris, , France

Investigational Site Number :2500005

Reims, , France

Investigational Site Number :2500003

Toulouse, , France

Investigational Site Number :3480004

Debrecen, , Hungary

Investigational Site Number :3480002

Orosháza, , Hungary

Investigational Site Number :3480005

Pécs, , Hungary

Investigational Site Number :3480003

Szeged, , Hungary

Investigational Site Number :3800001

Rozzano, Milano, Italy

Investigational Site Number :3800004

Ancona, , Italy

Investigational Site Number :3800003

Catanzaro, , Italy

Investigational Site Number :3800002

Milan, , Italy

Investigational Site Number :6200001

Coimbra, , Portugal

Investigational Site Number :6200002

Lisbon, , Portugal

Investigational Site Number :6200003

Porto, , Portugal

Investigational Site Number :4100002

Busan, Busan, South Korea

Investigational Site Number :4100003

Bucheon-si, Gyeonggi-do, South Korea

Investigational Site Number :4100007

Incheon, Incheon-gwangyeoksi, South Korea

Investigational Site Number :4100005

Seoul, Seoul-teukbyeolsi, South Korea

Investigational Site Number :4100001

Seoul, Seoul-teukbyeolsi, South Korea

Investigational Site Number :4100006

Seoul, Seoul-teukbyeolsi, South Korea

Investigational Site Number :7240009

Badalona, Barcelona [Barcelona], Spain

Investigational Site Number :7240001

Pontevedra, Galicia [Galicia], Spain

Investigational Site Number :7240008

Santullano, Principality of Asturias, Spain

Investigational Site Number :7240004

Córdoba, , Spain

Investigational Site Number :7240007

Madrid, , Spain

Investigational Site Number :7240003

Valencia, , Spain

Investigational Site Number :7240002

Zaragoza, , Spain

Investigational Site Number :1580005

Hsinchu, , Taiwan

Investigational Site Number :1580006

Kaohsiung City, , Taiwan

Investigational Site Number :1580008

Taichung, , Taiwan

Investigational Site Number :1580001

Taipei, , Taiwan

Investigational Site Number :1580002

Taipei, , Taiwan

Investigational Site Number :8260001

Redhill, Surrey, United Kingdom

Countries

United States; Canada; Chile; France; Hungary; Italy; Portugal; South Korea; Spain; Taiwan; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 38865146 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37142763 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.trialsummaries.com/Study/StudyDetails?id=25247&tenant=MT_SNY_9011

EFC16460 Plain Language Results Summary

Other Identifiers

2019-003801-90

Identifier Type: -

Identifier Source: secondary_id

U1111-1241-8174

Identifier Type: OTHER

Identifier Source: secondary_id

EFC16460

Identifier Type: -

Identifier Source: org_study_id