Evaluation of the Efficacy and Tolerability of Treatment With Interleukin-2 in Severe and Resistant Alopecia Areata (IL2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Centre Hospitalier Universitaire de Nice
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01840046
First received: April 23, 2013
Last updated: April 24, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Alopecia Areata
Drug: Interleukin-2
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy and Tolerability of Treatment With Interleukin-2 in Severe Alopecia Areata Resistant to Conventional Systemic Treatment

Further study details as provided by Centre Hospitalier Universitaire de Nice:

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. [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 months ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 10
Study Start Date: November 2012
Estimated Study Completion Date: November 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.

Drug: 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).


  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01840046

Contacts
Contact: Passeron Thierry, PhD +33494026488 passeron.t@chu-nice.fr
Contact: Bailet Olivier +3349203168 bailet.o@chu-nice.fr

Locations
France
CHU de Nice - Hôpital Archet Recruiting
Nice, Alpes-Maritimes, France, 06001
Contact: PASSERON Thierry, PhD    +33492036488    passeron.t@chu-nice.fr   
Principal Investigator: PASSERON Thierry, PhD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: PASSERON Thierry, PhD CHU de Nice - Hôpital de l'Archet - Dermatology
  More Information

No publications provided by Centre Hospitalier Universitaire de Nice

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01840046     History of Changes
Other Study ID Numbers: 12-PP-05
Study First Received: April 23, 2013
Last Updated: April 24, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Interleukin-2
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 27, 2014