NCT02557074

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2015

Typical duration for phase_3

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 22, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

December 15, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2019

Completed
Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

3.1 years

First QC Date

August 11, 2015

Last Update Submit

March 20, 2026

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (1)

  • Score Salt

    Success defined by a SALT score lower or equal to 25 at the end the study (12 months post-treatment). It will be calculated by 2 physicians blinded to the treatment received on standardized pictures.

    Once : at 12 months post-treatment

Secondary Outcomes (3)

  • Quality of life

    at one day, 22 days, 43 days, 64 days, 251 days, 434 days

  • Adverse Event

    at one day, 22 days, 43 days, 64 days, 251 days, 434 days

  • Satisfaction of patient

    at 12 months post-treatment

Study Arms (2)

IL2 - Group A

EXPERIMENTAL

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

Drug: IL2

Placebo - Group B

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

IL2DRUG

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

IL2 - Group A
placeboDRUG

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

Placebo - Group B

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Of more than 18 years old,
  • Affiliated to the social security system,
  • Clinical diagnosis of alopecia areata,
  • % 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

AP-HM - La timone - Dermatologie

Marseille, Bouche Du Rhône, 13005, France

Location

CHU de Nimes - Dermatologie

Nîmes, Languedoc-Roussillon, 30000, France

Location

CHI St Raphael Fréjus - Dermatologie

Fréjus, PACA, 83000, France

Location

CHU Montpellier - Dermatologie

Montpellier, 34000, France

Location

CHU de Nice - dermatologie

Nice, 06200, France

Location

AP-HP St Louis - Dermatologie

Paris, Île-de-France Region, 75000, France

Location

Related Publications (1)

  • Le Duff F, Bouaziz JD, Fontas E, Ticchioni M, Viguier M, Dereure O, Reygagne P, Montaudie H, Lacour JP, Monestier S, Richard MA, Passeron T. Low-Dose IL-2 for Treating Moderate to Severe Alopecia Areata: A 52-Week Multicenter Prospective Placebo-Controlled Study Assessing its Impact on T Regulatory Cell and NK Cell Populations. J Invest Dermatol. 2021 Apr;141(4):933-936.e6. doi: 10.1016/j.jid.2020.08.015. Epub 2020 Sep 14. No abstract available.

    PMID: 32941917RESULT

MeSH Terms

Conditions

Alopecia Areata

Interventions

Interleukin-2

Condition Hierarchy (Ancestors)

AlopeciaHypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

InterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsLymphokinesProteinsBiological Factors

Study Officials

  • Passeron Thierry, PUPH

    Centre Hospitalier Universitaire de Nice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2015

First Posted

September 22, 2015

Study Start

December 15, 2015

Primary Completion

February 2, 2019

Study Completion

December 2, 2019

Last Updated

March 24, 2026

Record last verified: 2026-03

Locations

FR(6)