Back to resultsEvaluation of the Efficacy and Tolerability of Treatment With Interleukin-2 in Severe and Resistant Alopecia Areata (IL2)
Primary Purpose
Alopecia Areata
Status
Terminated
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
Interleukin-2
Sponsored by
About this trial
This is an interventional treatment trial for Alopecia Areata
Eligibility Criteria
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
Sites / Locations
- CHU de Nice - Hôpital Archet
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Interleukin 2
Arm Description
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.
Outcomes
Primary Outcome Measures
Number of patients who obtained an improvement of at least 90% of the score validated severity score in alopecia areata in 2 months.
Number of patients who obtained an improvement of at least 90% of SALT (SALT 90) validated severity score in alopecia areata in 2 months.
Secondary Outcome Measures
Evaluation of the quality of life
Number of patients who obtained an improvement of at least 50% of score (SALT 90) validated severity score in alopecia areata in 2 months.
Assess the partial response rate. Evaluation of the effects of treatment on body hair and nail achieving.
Overall assessment by an independent investigator to regrow after treatment (Physician global assessment):
Evaluation of the quality of life before and at the end of treatment. Overall assessment by the patient (patient global assessment) of regrowth. Overall tolerability of treatment. Study population effects of IL2-R on the population of Treg cells in the blood. The effects of IL-2 on the inflammatory infiltrate and the distribution of regulatory T cells in the skin.
Full Information
NCT ID
NCT01840046
First Posted
April 23, 2013
Last Updated
August 30, 2022
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT01840046
Brief Title
Evaluation of the Efficacy and Tolerability of Treatment With Interleukin-2 in Severe and Resistant Alopecia Areata
Acronym
IL2
Official Title
Evaluation of the Efficacy and Tolerability of Treatment With Interleukin-2 in Severe Alopecia Areata Resistant to Conventional Systemic Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Terminated
Study Start Date
November 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interleukin 2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Interleukin-2
Intervention Description
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).
Primary Outcome Measure Information:
Title
Number of patients who obtained an improvement of at least 90% of the score validated severity score in alopecia areata in 2 months.
Description
Number of patients who obtained an improvement of at least 90% of SALT (SALT 90) validated severity score in alopecia areata in 2 months.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Evaluation of the quality of life
Description
Number of patients who obtained an improvement of at least 50% of score (SALT 90) validated severity score in alopecia areata in 2 months.
Assess the partial response rate. Evaluation of the effects of treatment on body hair and nail achieving.
Overall assessment by an independent investigator to regrow after treatment (Physician global assessment):
Evaluation of the quality of life before and at the end of treatment. Overall assessment by the patient (patient global assessment) of regrowth. Overall tolerability of treatment. Study population effects of IL2-R on the population of Treg cells in the blood. The effects of IL-2 on the inflammatory infiltrate and the distribution of regulatory T cells in the skin.
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PASSERON Thierry, PhD
Organizational Affiliation
CHU de Nice - Hôpital de l'Archet - Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nice - Hôpital Archet
City
Nice
State/Province
Alpes-Maritimes
ZIP/Postal Code
06001
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
24872229
Citation
Castela E, Le Duff F, Butori C, Ticchioni M, Hofman P, Bahadoran P, Lacour JP, Passeron T. Effects of low-dose recombinant interleukin 2 to promote T-regulatory cells in alopecia areata. JAMA Dermatol. 2014 Jul;150(7):748-51. doi: 10.1001/jamadermatol.2014.504.
Results Reference
derived
Learn more about this trial
Evaluation of the Efficacy and Tolerability of Treatment With Interleukin-2 in Severe and Resistant Alopecia Areata
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