TREg Activation in the Treatment of the PELADE (Alopecia Areata)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-15

Study Completion Date

2019-12-02

Brief Summary

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In a prospective pilot study the investigators showed that low doses of IL2 could be beneficial for severe AA inducing a long lasting regrowth in 4 out of the 5 patients treated.

The objective of this study is to compare the long term efficacy of low doses of IL2 versus placebo in a multicenter prospective randomized double blind study.

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Detailed Description

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Conditions

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Alopecia Areata

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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IL2 - Group A

Patient will received IL2 low doses (1.5 to 3MUI/d) -

* IL2 1.5MUI/d SC from day 1 to day 5 for the first course of treatment
* IL2 3MUI/d SC from day 1 to day 5 for the 3 following courses

Group Type EXPERIMENTAL

IL2

Intervention Type DRUG

IL2 1.5MUI/d SC from day 1 to day 5 for the first course of treatment IL2 3MUI/d SC from day 1 to day 5 for the 3 following courses

Placebo - Group B

NaCl 9% serum (placebo) NaCl 9% serum SC from day 1 to day 5 for the four courses of treatment

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

NaCl 9% serum SC from day 1 to day 5 for the four courses of treatment

Interventions

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IL2

IL2 1.5MUI/d SC from day 1 to day 5 for the first course of treatment IL2 3MUI/d SC from day 1 to day 5 for the 3 following courses

Intervention Type DRUG

placebo

NaCl 9% serum SC from day 1 to day 5 for the four courses of treatment

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Of more than 18 years old,
* Affiliated to the social security system,
* Clinical diagnosis of alopecia areata,
* 50 % of the surface of the scalp affected
* Last flaire started less than one year
* Alopecia areata resisting to at least 1 systematic treatment including phototherapy (UVB or PUVA), general corticosteroid therapy or methotrexate
* Signature of the informed consent

Exclusion Criteria

* Pregnancy or refusal of contraception at the women old enough to procreate,
* Refusal of contraception at the men
* Local treatment (dermocorticoïdes, minoxidil) or systematism (oral corticosteroid therapy, méthotrexate or the other immunosuppresseur) since less than 2 less,
* Evolutionary autoimmune cancer or disease or in forgiveness
* Excessive grip(taking) of alcohol (upper to 3 glasses of wine a day or one pre-lunch drink a day)
* Seropositivity VHC, VHB, or HIV
* Patient presenting a severe renal and/or hepatic insufficiency,
* Presenting patient one zoned, the chicken pox, the herpes, the tuberculosis, an evolutionary infectious disease, a respiratory failure …
* Vulnerable person (nobody under guardianship minor(miner), adults, deprived of freedom)
* IC in the treatment(processing) by IL-2R
* Presenting a contraindication to ProleukinR

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No