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

Centre Hospitalier Universitaire de Nice

Status and phase: Completed; Phase 3

Conditions: Alopecia Areata

Treatments: Drug: placebo; Drug: IL2

Study type: Interventional

Funder types: Other

Identifiers

NCT02557074

14-API-01

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 2 patient groups, including a placebo group

IL2 - Group A

Experimental group

Description:

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

Treatment:

Drug: IL2

Placebo - Group B

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo