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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT02557074

Alopecia Areata

COMPLETED PHASE3

1565nm Non-ablative Fractional Laser Treat Alopecia Areata

NCT05744505

Alopecia Areata

UNKNOWN NA

Treatment of Alopecia Areata (AA) With Dupilumab in Patients With and Without Atopic Dermatitis (AD)

NCT03359356

Alopecia Areata

COMPLETED PHASE2

Pilot Study of the Safety and Efficacy of Apremilast in Subjects With Moderate to Severe Alopecia Areata

NCT02684123

Alopecia Areata

COMPLETED NA

An Open-Label Single-Arm Clinical Trial to Evaluate The Efficacy of Abatacept in Moderate to Severe Patch Type Alopecia Areata

NCT02018042

Alopecia Areata

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alopecia Areata

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Interleukin 2

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.

Group Type EXPERIMENTAL

Interleukin-2

Intervention Type DRUG

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 / day (D1 to D5), S3, S6 and S9: 3 mille-International unit /Jour (D1 to D5).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Interleukin-2

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 / day (D1 to D5), S3, S6 and S9: 3 mille-International unit /Jour (D1 to D5).

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No