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

Primary Purpose

Alopecia Areata

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
IL2
placebo
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alopecia Areata

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • AP-HM - La timone - Dermatologie
  • AP-HP St Louis - Dermatologie
  • CHU de Nimes - Dermatologie
  • CHI St Raphael Fréjus - Dermatologie
  • CHU Montpellier - Dermatologie
  • CHU de Nice - dermatologie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

IL2 - Group A

Placebo - Group B

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Quality of life
The quality of life (QdV) will be estimated with the scale DLQI which is a scale of QdV validated for the dermatological diseases.
Adverse Event
The tolerance will be clinically and biologically estimated at each visit. The type and the rank of every AE will be raised.
Satisfaction of patient
The satisfaction of the patients will be estimated on an analog visual scale(ladder) going of 0 (not satisfied) to 10 (very satisfied).

Full Information

First Posted
August 11, 2015
Last Updated
December 3, 2019
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT02557074
Brief Title
TREg Activation in the Treatment of the PELADE (Alopecia Areata)
Acronym
TreatPelade
Official Title
TREg Activation in the Treatment of the PELADE (Alopecia Areata). Double Blind Randomized Placebo Controlled Comparative Study Using Low Doses of IL2
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
December 15, 2015 (Actual)
Primary Completion Date
February 2, 2019 (Actual)
Study Completion Date
December 2, 2019 (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
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.

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 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IL2 - Group A
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo - Group B
Arm Type
Placebo Comparator
Arm Description
NaCl 9% serum (placebo) NaCl 9% serum SC from day 1 to day 5 for the four courses of treatment
Intervention Type
Drug
Intervention Name(s)
IL2
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
NaCl 9% serum SC from day 1 to day 5 for the four courses of treatment
Primary Outcome Measure Information:
Title
Score Salt
Description
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.
Time Frame
Once : at 12 months post-treatment
Secondary Outcome Measure Information:
Title
Quality of life
Description
The quality of life (QdV) will be estimated with the scale DLQI which is a scale of QdV validated for the dermatological diseases.
Time Frame
at one day, 22 days, 43 days, 64 days, 251 days, 434 days
Title
Adverse Event
Description
The tolerance will be clinically and biologically estimated at each visit. The type and the rank of every AE will be raised.
Time Frame
at one day, 22 days, 43 days, 64 days, 251 days, 434 days
Title
Satisfaction of patient
Description
The satisfaction of the patients will be estimated on an analog visual scale(ladder) going of 0 (not satisfied) to 10 (very satisfied).
Time Frame
at 12 months post-treatment

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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Passeron Thierry, PUPH
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
AP-HM - La timone - Dermatologie
City
Marseille
State/Province
Bouche Du Rhône
ZIP/Postal Code
13005
Country
France
Facility Name
AP-HP St Louis - Dermatologie
City
Paris
State/Province
Ile De France
ZIP/Postal Code
75000
Country
France
Facility Name
CHU de Nimes - Dermatologie
City
Nîmes
State/Province
Languedoc-Roussillon
ZIP/Postal Code
30000
Country
France
Facility Name
CHI St Raphael Fréjus - Dermatologie
City
Fréjus
State/Province
Paca
ZIP/Postal Code
83000
Country
France
Facility Name
CHU Montpellier - Dermatologie
City
Montpellier
ZIP/Postal Code
34000
Country
France
Facility Name
CHU de Nice - dermatologie
City
Nice
ZIP/Postal Code
06200
Country
France

12. IPD Sharing Statement

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

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