Alopecia AreataPhase 3TreatPeladeNCT02557074
TREg Activation in the Treatment of the PELADE (Alopecia Areata)
A Phase 3 study testing IL2 in people with Alopecia Areata, run by Centre Hospitalier Universitaire de Nice at 6 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- IL2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 6 sitesFrance
- Study dates
- 15 Dec 2015to 2 Dec 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CHI St Raphael Fréjus - Dermatologie
Fréjus, PACA, 83000
AP-HM - La timone - Dermatologie
Marseille, Bouche Du Rhône, 13005
CHU Montpellier - Dermatologie
Montpellier, 34000
CHU de Nice - dermatologie
Nice, 06200
CHU de Nimes - Dermatologie
Nîmes, Languedoc-Roussillon, 30000
AP-HP St Louis - Dermatologie
Paris, Île-de-France Region, 75000
About this study
Official title: TREg Activation in the Treatment of the PELADE (Alopecia Areata). Double Blind Randomized Placebo Controlled Comparative Study Using Low Doses of IL2
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.
- Conditions
- Alopecia Areata
- Being tested
- IL2, placebo
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
placeboDrug
NaCl 9% serum SC from day 1 to day 5 for the four courses of treatment
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Once : at 12 months post-treatment
Secondary outcomes (3)
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.
Measured: at one day, 22 days, 43 days, 64 days, 251 days, 434 days
Adverse Event
The tolerance will be clinically and biologically estimated at each visit. The type and the rank of every AE will be raised.
Measured: at one day, 22 days, 43 days, 64 days, 251 days, 434 days
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).
Measured: at 12 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2015 (estimated)
- Study start15 Dec 2015
- Primary completion2 Feb 2019
- Study completion2 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Passeron Thierry, PUPH, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02557074
- Sponsor's protocol ID
- 14-API-01
- Acronym
- TreatPelade
- Status last verified
- Mar 2026
- First submitted
- 11 Aug 2015
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32941917
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TREg Activation in the Treatment of the PELADE (Alopecia Areata). Double Blind Randomized Placebo Controlled Comparative Study Using Low Doses of IL2
- ClinicalTrials.gov ID
- NCT02557074
- Acronym / sponsor ID
- TreatPelade / 14-API-01
- Conditions
- Alopecia Areata
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 15 Dec 2015 (actual)
- Primary completion
- 2 Feb 2019 (actual)
- Study completion
- 2 Dec 2019 (actual)
- First posted
- 22 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IL2 - Group A | Experimental | Drug: IL2Patient 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 |
| Placebo - Group B | Placebo comparator | Drug: placeboNaCl 9% serum (placebo) NaCl 9% serum SC from day 1 to day 5 for the four courses of treatment |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IL2IL2 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 - Group A |
| placeboNaCl 9% serum SC from day 1 to day 5 for the four courses of treatment | Drug | Placebo - Group B |
Primary outcome
Score Salt
Time frame: Once : at 12 months post-treatment
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.
3 secondary outcomes
Quality of life
Time frame: at one day, 22 days, 43 days, 64 days, 251 days, 434 days
Adverse Event
Time frame: at one day, 22 days, 43 days, 64 days, 251 days, 434 days
Satisfaction of patient
Time frame: at 12 months post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Results publication: PubMed 32941917Le 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Passeron Thierry, PUPH principal investigator
Centre Hospitalier Universitaire de Nice
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IL2 in people with Alopecia Areata, run by Centre Hospitalier Universitaire de Nice at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score Salt (time frame: Once : at 12 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02557074, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.