Evaluation of the Efficacy and Tolerability of Treatment With Interleukin-2 in Severe and Resistant Alopecia Areata (IL2)

Centre Hospitalier Universitaire de Nice

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Alopecia Areata

Treatments: Drug: Interleukin-2

Study type: Interventional

Funder types: Other

Identifiers

NCT01840046

12-PP-05

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Interleukin 2

Experimental group

Description:

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.

Treatment:

Drug: Interleukin-2