Evaluation of the Efficacy and Tolerability of Treatment With Interleukin-2 in Severe and Resistant Alopecia Areata

NCT01840046 | Terminated Phase 1

• 1 other identifier: 12-PP-05
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

Alopecia areata is an autoimmune disease associated with infiltration of cluster of differentiation 4(CD4 +) and cluster of differentiation 8 (CD8) + cells around the hair follicles. One of the therapeutic approaches of inflammatory diseases such as alopecia areata is the induction of tolerance. This tolerance induction can be obtained by stimulating regulatory T cells (Treg). The low-dose interleukin-2 plays a central role in the development, expansion, regulation and survival of regulatory T cells CD4 + cluster of differentiation 25 (CD25) + forkhead box protein 3 (FoxP3). Recently, recombinant interleukin 2 (IL2-R) with low dose showed very promising results in two inflammatory disease (GVHD vasculitis and cryoglobulinemia secondary to hepatitis C): clinical efficacy, increased population Treg in the blood and an excellent safety profile. We hypothesized that administration of IL2-R in patients with severe alopecia areata might allow regrowth via activation of Treg and thus induce regrowth of the air.

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (1)

• Number of patients who obtained an improvement of at least 90% of the score validated severity score in alopecia areata in 2 months.

  Number of patients who obtained an improvement of at least 90% of SALT (SALT 90) validated severity score in alopecia areata in 2 months.

  2 months

Secondary Outcomes (1)

• Evaluation of the quality of life

  2 months

Study Arms (1)

Interleukin 2

EXPERIMENTAL

The patient will receive 4 cycles of recombinant interleukin 2 (aldesleukin, Proleukin ®) subcutaneously according to the following dosing schedule: 5 to 7 days (Monday to Friday) in weeks 1, 3, 6 and 9. The dosage is as follows: S1: 1.5 mille-International unit (MIU) / day D1 to D5, S3, S6 and S9: 3 mille-International unit /Jour D1 to D5.

Drug: Interleukin-2

Interventions

Interleukin-2 DRUG

The patient will receive 4 cycles of recombinant interleukin 2 (aldesleukin, Proleukin ®) subcutaneously according to the following dosing schedule: 5 to 7 days (Monday to Friday) in weeks 1, 3, 6 and 9. The dosage is as follows: S1: 1.5 mille-International unit / day (D1 to D5), S3, S6 and S9: 3 mille-International unit /Jour (D1 to D5).

Interleukin 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age ≥ 18 years, 60 ≤ years.
• Male or female
• Clinical diagnosis of alopecia areata,
• Severe alopecia areata (\> 50% of the surface of the scalp reached)
• Alopecia areata resistant to at least one systemic therapy: phototherapy (UVB or PUVA), methotrexate or corticosteroids
• Signature of the informed consent and authorization of the right image
• Effective contraception will be maintained for the duration of the study.
• Affiliation to the Social Security

You may not qualify if:

• Pregnancy or refusal of contraception in women of childbearing age,
• Refusal of contraception for men
• Local treatment (corticosteroids, minoxidil) or systemic (oral corticosteroids, methotrexate or other immunosuppressive agents) for less than 2 months,
• Cancer or autoimmune disease or in remission evolutionary
• Excessive alcohol intake (more than 3 glasses of wine a day or a drink per day)
• HIV, hepatitis C virus, hepatitis B virus
• Patient with renal and / or hepatic impairment,
• Patient with shingles, chickenpox, herpes, tuberculosis, an infectious disease scalable, respiratory failure ...
• Vulnerable person (anyone younger, adults under guardianship, deprived of liberty)
• Indication against treatment with IL2-R
• Presenting an indication against the Proleukin

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice - Hôpital Archet

Nice, Alpes-Maritimes, 06001, France

Location

Related Publications (1)

• Castela E, Le Duff F, Butori C, Ticchioni M, Hofman P, Bahadoran P, Lacour JP, Passeron T. Effects of low-dose recombinant interleukin 2 to promote T-regulatory cells in alopecia areata. JAMA Dermatol. 2014 Jul;150(7):748-51. doi: 10.1001/jamadermatol.2014.504.

  PMID: 24872229 DERIVED

MeSH Terms

Conditions

Alopecia Areata

Interventions

Interleukin-2

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Study Officials

• PASSERON Thierry, PhD

  CHU de Nice - Hôpital de l'Archet - Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2013
• First Posted: April 25, 2013
• Study Start: November 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: May 1, 2013
• Last Updated: August 31, 2022

Record last verified: 2013-03

Locations

FR (1)