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

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Brief Title

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

Official Title

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

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.
    


Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 Evaluation of the quality of life

Condition

Alopecia Areata

Intervention

Interleukin-2

Study Arms / Comparison Groups

 Interleukin 2
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

10

Start Date

November 2012

Completion Date

November 2013

Primary Completion Date

November 2012

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

PASSERON Thierry, PhD, +33494026488, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT01840046

Organization ID

12-PP-05


Responsible Party

Sponsor

Study Sponsor

Centre Hospitalier Universitaire de Nice


Study Sponsor

PASSERON Thierry, PhD, Principal Investigator, CHU de Nice - Hôpital de l'Archet - Dermatology


Verification Date

March 2013