Alopecia AreataPhase 2NCT05551793
Regeneron AA Multicenter (Dupilumab)
A Phase 2 study testing Dupilumab in people with Alopecia Areata, run by Emma Guttman at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- Dupilumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 Apr 2023to 31 Oct 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. While on investigational product and for at least 28 days after taking the last dose of investigational product (IP), FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options described below:
- 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;
- Option 2: Male or female condom (latex condom or non-latex condom NOT made out of natural [animal] membrane [for example, polyurethane]); PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.
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- If subject is a female of non-childbearing potential, she must have documented history of infertility, be in a menopausal state for one year, or had a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy.
- Subject has a history of at least 6 months of moderate to severe AA (≥ 50% scalp involvement) as measured using the SALT score; OR subject has ≥ 95% loss of scalp hair for enrollment as AA totalis (AT) or universalis (AU) subtypes.
- Subject has a screening IgE > 200 and/or personal and/or familial history of atopy.
- Subjects must meet the following laboratory criteria:
- White blood cell count ≥ 3000/mm3 (≥ 3.0 x 109/L) and < 14,000/mm3 (≤ 14 x 109/L).
- Platelet count ≥ 100,000/μL (≥ 100 x 109/L).
- Serum creatinine ≤ 1.5 mg/dL (≤ 132.6 μmol/L).
- AST (SGOT) and ALT (SGPT) ≤ 2 x upper limit of normal (ULN). If the initial test shows ALT or AST > 2 times the ULN, one repeat test is allowed during the Screening Phase.
- Total bilirubin ≤ 2 mg/dL (34 μmol/L). If the initial test shows total bilirubin > 2 mg/dL (34 μmol/L), one repeat test is allowed during the Screening Phase.
- Hemoglobin ≥ 10 g/dL (≥ 6.2 mmol/L).
- Subject is judged to be in otherwise good overall health following a detailed medical and medication history, physical examination, and laboratory testing.
Who cannot join
- The presence of any of the following will exclude a subject from enrollment:
- 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.
- Subject has an active bacterial, viral, or helminth parasitic infections; OR a history of ongoing, recurrent severe infections requiring systemic antibiotics
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- Subject with a known or suspected underlying immunodeficiency or immune-compromised state as determined by the investigator.
- Subject has a concurrent or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, intestinal, metabolic, endocrine, pulmonary, cardiovascular, or neurological disease.
- Active hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or positive HIV serology or active or untreated latent tuberculosis at the time of screening for subjects determined by the investigators to be at high-risk for this disease.
- Subject has a suspected or active lymphoproliferative disorder or malignancy; OR a history of malignancy within 5 years before the Baseline assessment, except for completely treated in situ non-melanoma skin and cervical cancers without evidence of metastasis.
- Subject has received a live attenuated vaccine ≤ 30 days prior to study randomization.
- Subject has any uncertain or clinically significant laboratory abnormalities that may affect interpretation of study data or endpoints.
- Subject has any other medical or psychological condition that, in the opinion of the investigator, may present additional unreasonable risks as a result of their participation in the study and/or interfere with clinic visits and necessary study assessments.
- History of adverse systemic or allergic reactions to any component of the study drug.
- Severe, untreated asthma or a history of life-threatening asthma exacerbations while on appropriate anti-asthmatic mediations.
- Use of systemic immunosuppressive medications, including, but not limited to, cyclosporine, systemic or intralesional corticosteroids, mycophenolate mofetil, azathioprine, methotrexate, tacrolimus, or ultraviolet (UV) phototherapy with/without Psoralen Ultraviolet A (PUVA) therapy within 4 weeks prior to randomization.
- Use of an oral JAK inhibitor (tofacitinib, ruxolitinib, baricitinib, or investigational oral JAK Inhibitors) within 12 weeks prior to the Baseline visit.
- Subject has been previously treated with dupiliumab.
- Subject has used topical corticosteroids, and/or tacrolimus, and/or pimecrolimus within 1 week before the Baseline visit.
- Subject currently uses or plans to use anti-retroviral therapy at any time during the study.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
University of California, Irvine
Irvine, California, 92697
Jamy Paniagua, 949-824-7103, jamyp@hs.uci.edu
Natasha A Mesinkovska, MD PhD
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Giselle Singer, 212-241-3288, giselle.singer@mssm.edu
Emma Guttman-Yassky
- Recruiting
UR Dermatology at College Town
Rochester, New York, 14620
Alicia Papalia, 585-273-4195, Alicia_papalia@urmc.rochester.edu
Lisa Beck
About this study
Official title: Dupilumab in the Treatment of Alopecia Areata Patients With an Atopic Background and/or High IgE
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).
- Conditions
- Alopecia Areata
- Being tested
- Dupilumab, 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.
DupilumabDrug
Dupilumab: 300mg SC injections
PlaceboDrug
Placebo: SC injections of equivalent volume
| Study group | Role | What they receive |
|---|---|---|
| Dupilumab | Experimental | Dupilumab: weekly 300mg SC injections Manufacturer: Regeneron Receives: Drug: Dupilumab |
| Placebo | Placebo comparator | Placebo: weekly SC injections of equivalent volume Manufacturer: Regeneron Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 48
Secondary outcomes (10)
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.
Measured: Week 48
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.
Measured: Weeks 16 up to 48
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.
Measured: Weeks 64 up to 96
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.
Measured: Baseline and Week 48
Change in the Alopecia Areata Quality of Life questionnaire (AA-QoL)
Changes in the Alopecia Areata Quality of Life questionnaire (AA-QoL) from Baseline compared to Week 48. AA-QoL scale measures how severe the subjects feel their alopecia areata symptoms have been in the past week (scale options: very much, a lot, a little, not at all).
Measured: Baseline and Week 48
Change in Alopecia Areata Physician's Global Assessment (aaPGA) scores
Changes in Alopecia Areata Physician's Global Assessment (aaPGA) scores from Baseline compared to Week 48. The aaPGA is used to assess the clinical response to treatment based on a 6-point scale ranging from 0 (no regrowth) to 5 (100% regrowth), where higher scores indicate greater hair regrowth. The number of patients with a score of 0 or 1 will be compared.
Measured: Baseline and Week 48
Difference in Alopecia Areata Physician's Global Assessment (aaPGA) scores
Difference in Alopecia Areata Physician's Global Assessment (aaPGA) scores between dupilumab-treated group and placebo-treated group from Baseline compared to Week 48. The aaPGA is used to assess the clinical response to treatment based on a 6-point scale ranging from 0 (no regrowth) to 5 (100% regrowth), where higher scores indicate greater hair regrowth. The number of patients with a score of 0 or 1 will be compared.
Measured: Baseline to Week 48
Change in Eyelash Assessment Score
Changes in eyelash scores from Weeks 16 through 48. Eyelash Assessment Score measures hair loss. Scale: 0= None, 1= Minimal eyelashes, 2= Moderate eyelashes, 3= Prominent eyelashes, 4= Very prominent eyelashes. Score change from baseline will be calculated, where higher scores indicate greater eyelash loss.
Measured: Weeks 16 up to 48
Change in Eyebrow Assessment Score
Changes in eyebrow scores from Weeks 16 through 48. Eyebrow Assessment Score measures hair loss. Scale: 0= None, 1= Minimal eyebrows, 2= Moderate eyebrows, 3= Prominent eyebrows, 4= Very prominent eyebrows. Score change from baseline will be calculated, where higher scores indicate greater eyebrow loss.
Measured: Weeks 16 up to 48
Number of adverse events reported
Number of adverse events reported throughout the study. The adverse event will be described and categorized as treatment emergent, serious, abnormal in vital signs, and abnormal in lab parameters.
Measured: Baseline up to Week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start10 Apr 2023
- Primary completion30 Nov 2027 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emma Guttman
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor-investigator, Emma Guttman, Icahn School of Medicine at Mount Sinai
- Investigators
- Emma Guttman-Yassky, MD, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05551793
- Sponsor's protocol ID
- STUDY-22-01021
- Status last verified
- Jun 2026
- First submitted
- 20 Sep 2022
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Not shared
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dupilumab in the Treatment of Alopecia Areata Patients With an Atopic Background and/or High IgE
- ClinicalTrials.gov ID
- NCT05551793
- Acronym / sponsor ID
- STUDY-22-01021
- Conditions
- Alopecia Areata
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Emma GuttmanUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 23 Sep 2022 (actual)
- 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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dupilumab | Experimental | Drug: DupilumabDupilumab: weekly 300mg SC injections Manufacturer: Regeneron |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo: weekly SC injections of equivalent volume Manufacturer: Regeneron |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
- Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. While on investigational product and for at least 28 days after taking the last dose of investigational product (IP), FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options described below:
- If subject is a female of non-childbearing potential, she must have documented history of infertility, be in a menopausal state for one year, or had a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy.
Key exclusion criteria (20 listed)
- 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.
- Subject has an active bacterial, viral, or helminth parasitic infections; OR a history of ongoing, recurrent severe infections requiring systemic antibiotics
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 |
|---|---|---|
| DupilumabDupilumab: 300mg SC injections | Drug | Dupilumab |
| PlaceboPlacebo: SC injections of equivalent volume | Drug | Placebo |
Primary outcome
Change in the SALT score
Time frame: Baseline and Week 48
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.
10 secondary outcomes
Number of patients achieving an absolute SALT score of ≤ 20
Time frame: Week 48
Number of patients achieving improvement in Severity of Alopecia Tool (SALT) score
Time frame: Weeks 16 up to 48
Number of patients achieving improvement in Severity of Alopecia Tool (SALT) score
Time frame: Weeks 64 up to 96
Change in the Alopecia Areata Symptom Impact Scale (AASIS)
Time frame: Baseline and Week 48
Change in the Alopecia Areata Quality of Life questionnaire (AA-QoL)
Time frame: Baseline and Week 48
Change in Alopecia Areata Physician's Global Assessment (aaPGA) scores
Time frame: Baseline and Week 48
Difference in Alopecia Areata Physician's Global Assessment (aaPGA) scores
Time frame: Baseline to Week 48
Change in Eyelash Assessment Score
Time frame: Weeks 16 up to 48
Change in Eyebrow Assessment Score
Time frame: Weeks 16 up to 48
Number of adverse events reported
Time frame: Baseline up to Week 96
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No. Not shared
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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.
Emma Guttman-Yassky, MD, PhD principal investigator
Icahn School of Medicine at Mount Sinai
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dupilumab in people with Alopecia Areata, run by Emma Guttman at 3 sites in United States.
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 17 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giselle Singer (212-241-3288, giselle.singer@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the SALT score (time frame: Baseline and Week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jun 2026.