Efficacy and Safety of Dupilumab Chronic Hands Eczema Refractory to Highly Potent Topical Corticosteroids

NCT03861455 | Completed Phase 2

• 2 other identifiers: RC31/18/02692018-002830-19
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 4

Brief Summary

Dupilumab has recently demonstrated high efficacy and good safety profile in the treatment of moderate-to-severe atopic dermatitis. There is a crucial need of developing new treatment options in Chronic hand eczema refractory to topical therapy. Investigators hypothesise that Dupilumab will also have high efficacy and good safety profile in the treatment of moderate to severe Chronic hand eczema refractory to highly potent topical corticosteroids.

Conditions

Chronic Hand Eczema

Keywords

Chronic Hand Eczema

Outcome Measures

Primary Outcomes (1)

• severity score mTLSS (modified Total Lesion Symptom Score)

  The primary outcome measure will be the 16-week percent change since baseline of the severity score mTLSS (modified Total Lesion Symptom Score) The mTLSS combines an evaluation of hand eczema lesions severity including 6 key signs (erythema, desquamation, lichenification/hyperkeratosis, vesiculae, oedema, fissures) and the intensity of pruritus and pain. The seven individual CHE symptoms; (erythema, scaling, lichenification or hyperkeratosis, vesiculation, edema, fissures, and pruritus/pain) form the composite scale of mTLSS' strength and each one of them scores from 0 (mild) to 3 (severe). The scores are summed, extending from a base estimation of 0 (no signs or symptoms) to the most extreme of 21 (more serious disease).

  Week 16

Secondary Outcomes (14)

• Evolution of pruritus

  Week 16

• Evolution of pain

  Week 16

• Improvement of quality of life

  Week 16

• Improvement of quality of life by EQ-5D-5L

  Week 16

• evolution of sleep loss

  Week 16

Study Arms (2)

dupilumab group

EXPERIMENTAL

patient receive dupilumab 300 mg every 2 weeks after a 600 mg-loading dose of dupilumab on day 0

Drug: Dupilumab

placebo group

PLACEBO COMPARATOR

patient receive placebo

Drug: placebo

Interventions

Dupilumab DRUG

patient receive dupilumab 300 mg every 2 weeks after a 600 mg-loading dose of dupilumab on day 0

dupilumab group

placebo DRUG

patient receive placebo

placebo group

Eligibility Criteria

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

You may qualify if:

• Patients affiliated to a social insurance protection regimen.
• Patients with moderate to severe chronic (\>6 months) hand eczema with an Investigator global assessment (IGA) of 3 or 4 (out of a scale of 0 to 4).
• Patients intolerant (according to the physician) or resistant to highly potent topical corticosteroids. Inadequate response (resistance) to highly potent topical corticosteroids is defined as a history of failure to achieve and maintain remission or a low disease activity state (comparable to an IGA score of 0 \[indicating clear\] to 2 \[indicating mild\]) despite treatment with a daily regimen of highly potent topical corticosteroids applied for 14 days or for the maximum duration recommended for highly potent topical corticosteroids.
• Patients who are able to understand the study procedures including the ability to complete patient-oriented questionnaires.
• Patients who are able to apply a stable dose of emollients within 7 days before the baseline visit.
• Patients who agree to sign the written informed consent.

You may not qualify if:

• Hypersensitivity to dupilumab or to any of its ingredients
• Patients under adult autonomy protection system
• Any other condition (e;g., psoriasis) on the hands that according to the investigator will impair the ability to evaluate treatment effect.
• Treatment with topical corticosteroids or topical calcineurin inhibitors within one week of baseline.
• Treatment with oral immunosuppressants (including cyclosporine, methotrexate, azathioprine, mycophenolate mofetil), alitretinoin or phototherapy within 4 weeks of baseline visit.
• Treatment with an investigational drug within 8 weeks (or 5 half-lives) of baseline.
• Active chronic infection requiring the use of a systemic antibiotic within 2 weeks before study start.
• Known or suspected history of immunosuppression, including history of invasive opportunistic infections (e.g., tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystis, aspergillosis) despite infection resolution; or unusually frequent, recurrent, or prolonged infections, per investigator judgment.
• History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
• Positive for hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C antibody at the screening visit.
• Patients with known helminth infections.
• Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study. Women of childbearing potential who are sexually active and unwilling to use an adequate birth control method

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (4)

Saint André Hospital

Bordeaux, 30000, France

Location

Hôpital Saint Eloi

Montpellier, 34000, France

Location

CHU Lyon-Sud Département d'allergologie et d'immunologie clinique

Pierre-Bénite, 69495, France

Location

Larrey Hospital

Toulouse, 31059, France

Location

Related Publications (5)

• Halioua B. [Hand eczema : disability and impact]. Ann Dermatol Venereol. 2014 Jun;141 Suppl 1:S111-6. doi: 10.1016/S0151-9638(14)70148-6. French.

  PMID: 24953620 BACKGROUND

• Cortesi PA, Scalone L, Belisari A, Bonamonte D, Cannavo SP, Cristaudo A, De Pita O, Gallo R, Giannetti A, Gola M, Pigatto PD, Mantovani LG. Cost and quality of life in patients with severe chronic hand eczema refractory to standard therapy with topical potent corticosteroids. Contact Dermatitis. 2014 Mar;70(3):158-68. doi: 10.1111/cod.12130. Epub 2013 Sep 19.

  PMID: 24102212 BACKGROUND

• Fowler JF, Graff O, Hamedani AG. A phase 3, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of alitretinoin (BAL4079) in the treatment of severe chronic hand eczema refractory to potent topical corticosteroid therapy. J Drugs Dermatol. 2014 Oct;13(10):1198-204.

  PMID: 25607554 BACKGROUND

• Blauvelt A, de Bruin-Weller M, Gooderham M, Cather JC, Weisman J, Pariser D, Simpson EL, Papp KA, Hong HC, Rubel D, Foley P, Prens E, Griffiths CEM, Etoh T, Pinto PH, Pujol RM, Szepietowski JC, Ettler K, Kemeny L, Zhu X, Akinlade B, Hultsch T, Mastey V, Gadkari A, Eckert L, Amin N, Graham NMH, Pirozzi G, Stahl N, Yancopoulos GD, Shumel B. Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial. Lancet. 2017 Jun 10;389(10086):2287-2303. doi: 10.1016/S0140-6736(17)31191-1. Epub 2017 May 4.

  PMID: 28478972 BACKGROUND

• Molin S, Merl J, Dietrich KA, Regauer M, Flaig M, Letule V, Saucke T, Herzinger T, Ruzicka T, Hauck SM. The hand eczema proteome: imbalance of epidermal barrier proteins. Br J Dermatol. 2015 Apr;172(4):994-1001. doi: 10.1111/bjd.13418. Epub 2015 Feb 26.

  PMID: 25244099 BACKGROUND

MeSH Terms

Interventions

dupilumab

Study Officials

• Marie Tauber

  Lyon Sud Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized 1:1 to receive dupilumab 300 mg every 2 weeks after a 600 mg-loading dose of dupilumab on day 0 or placebo.

Study Record Dates

• First Submitted: November 28, 2018
• First Posted: March 4, 2019
• Study Start: July 15, 2019
• Primary Completion: November 9, 2023
• Study Completion: December 20, 2023
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)