Health TrialsbyHealthPanel

Regeneron AA Multicenter (Dupilumab)

ConditionAlopecia Areata
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEmma Guttman

About this trial

This is a prospective, randomized, double blind, placebo-controlled clinical trial. The study will take place at 4 sites. This trial will enroll a total of 68 patients with moderate to severe AA (affecting more than 50% of the scalp) at the time of screening with a targeted 54 subjects completers through Week 48. AA subjects must have evidence of hair regrowth within the last 7 years of their last episode of hair loss; and have screening IgE ≥ 200 and/or have personal and/or familial history of atopy.

Subjects will be randomized (2:1) to either receive weekly dupilumab or placebo for 48 weeks, with all subjects completing participation through Week 48 receiving an additional 48 weeks of dupilumab (through Week 96).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female subjects who are at least 18 years old at the time of informed consent.

Subject is able to understand and voluntarily sign an informed consent document prior to participation in any study assessments or procedures.

Subject is able to adhere to the study visit schedule and other protocol requirements.

Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy, OR;

Disqualifiers

Subject is pregnant or breastfeeding.

Subject's cause of hair loss is indeterminable and/or they have concomitant causes of alopecia, such traction, cicatricial, pregnancy-related, drug-induced, telogen effluvium, or advanced androgenetic alopecia (i.e. Ludwig Type III or Norwood-Hamilton Stage ≥ V).

Subject has a history of AA with no evidence of hair regrowth for ≥ 7 years since their last episode of hair loss.

Severe, uncontrolled asthma or a history of life-threatening asthma exacerbations while on appropriate anti-asthmatic mediations.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dupilumab

    Drug

    Dupilumab: 300mg SC injections

  • Placebo

    Drug

    Placebo: SC injections of equivalent volume

Treatment groups

76 Participants
are divided into 2 treatment groups
Group A: DupilumabExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in the SALT score

Changes in the SALT score from baseline compared to week 48. SALT score is the sum of percentage of hair loss in all areas (higher score indicates greater hair loss). The change between baseline and Week 48 will be compared.

Time frame
Baseline and Week 48

Secondary outcomes

1

Number of patients achieving an absolute SALT score of ≤ 20

Number of patients achieving an absolute SALT score of ≤ 20. SALT score is the sum of percentage of hair loss in all areas (higher score indicates greater hair loss). Total percentage of patients with absolute SALT score of ≤ 20 will be calculated.

Time frame
Week 48
2

Number of patients achieving improvement in Severity of Alopecia Tool (SALT) score

Number of patients achieving improvement in Severity of Alopecia Tool (SALT) score. SALT score is the sum of percentage of hair loss in all areas (higher score indicates greater hair loss). The proportion of patients achieving at least 30%/50%/75%/90% improvement will be calculated from weeks 16 to week 48.

Time frame
Weeks 16 up to 48
3

Number of patients achieving improvement in Severity of Alopecia Tool (SALT) score

SALT score is the sum of percentage of hair loss in all areas (higher score indicates greater hair loss). The proportion of patients achieving at least 30%/50%/75%/90% improvement will be calculated from weeks 64 to week 96.

Time frame
Weeks 64 up to 96
4

Change in the Alopecia Areata Symptom Impact Scale (AASIS)

Changes in the Alopecia Areata Symptom Impact Scale (AASIS) from baseline compared to Week 48. AASIS scale measures how the severe the subjects feel their alopecia areata symptoms have been in the past week (scale 0-10 where 0 indicates the symptom was not present and 10 indicates the symptom was as bad as you can imagine), where higher scores indicate worse symptoms.

Time frame
Baseline and Week 48

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Emma Guttman

Lead sponsor

Icahn School of Medicine at Mount Sinai

Sponsor institution

Regeneron Pharmaceuticals

Collaborator

Source ClinicalTrials.gov
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