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

• Status: Completed
• Trial end date: 2019-12-02
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Criteria

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