A Phase 2 interventional study of Dupilumab and Placebo in Alopecia Areata, sponsored by Icahn School of Medicine at Mount Sinai. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-13.
Sponsored by Icahn School of Medicine at Mount Sinai · Phase 2, Interventional, and Treatment
Among 98 studies in Alopecia Areata with a site in United States — 21 open to participants now, 32 under way, 8 of them phase 3. Alopecia Areata · United States.
Among the 98 studies in Alopecia Areata with a site in United States, this one is the 35th largest by enrollment of the 84 interventional ones, is one of 6 that started in 2018, is one of 42 in phase 2, and was the 35th registered.
220 studies on the registry are indexed under Alopecia Areata; 61 are open to participants now.
This study's enrollment of 60 is above the median of 50 across 171 interventional studies indexed under Alopecia Areata.
Browse Alopecia Areata studies →21 of the 98 studies in Alopecia Areata with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 41 Alopecia Areata studies recruiting now, 16 (39%) set no upper age limit and 21 (51%) stop at 75 or younger; 20 take children under 18; 5 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →98 studies; the count open now beside each. This study's row is marked.
First in 1997; this study’s year is marked. 6 started in 2018.
Median enrollment 46 across the 84 interventional studies, 2,300 across the 14 observational. Of the 60 that completed or were terminated, 42 (70%) have results posted.
52 of 98 have an industry lead sponsor. The 10 most frequent:
Icahn School of Medicine at Mount Sinai is the lead sponsor of 776 studies on the registry; 176 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 83 (66%) have results posted.
Icahn School of Medicine at Mount Sinai has 6 studies filed under Alopecia Areata — fewer than ten, so there is no comparison to draw.
10 of the studies in Alopecia Areata with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07029711Phase 3PfizerA Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata | 2026-12-02 |
| NCT03898479Phase 3Sun Pharmaceutical Industries, Inc.Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults With Alopecia Areata | 2027-05 |
| NCT06826196Aldena TherapeuticsA Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ALD-102 Solution in Subjects With Alopecia Areata | 2026-11 |
| NCT07821216PfizerReal-World Effectiveness of Ritlecitinib in Alopecia Areata Patients in the US: A Retrospective Analysis Using EHR and Claims Data | 2026-11-20 |
| NCT06602232Dren BioA Study of DR-01 in Subjects With Alopecia Areata and Vitiligo | 2027-05 |
Among the 98 studies in Alopecia Areata with a site in United States, from their registry updates:
Alopecia areata is a medical condition, in which the hair falls out in patches. The hair can fall out on the scalp or elsewhere on the face and body. Alopecia areata is an autoimmune skin disease, which means that the immune system is recognizing the hair follicles as foreign and attacking them, causing round patches of hair loss. It can progress to total scalp hair loss (alopecia totalis) or complete body hair loss (alopecia universalis). The scalp is the most commonly affected area, but the beard or any hair-bearing site can be affected alone or together with the scalp. Alopecia areata occurs in males and females of all ages, and is a highly unpredictable condition that tends to recur. Alopecia areata can cause significant distress to both patients and their families. In this study, the aim is to assess the effects of dupilumab in patients with alopecia areata.
The purpose of this study is to assess whether dupilumab can be a helpful treatment for alopecia areata.
This is a randomized, double-blind, placebo-controlled pilot study of a total of 54 subjects with moderate to severe alopecia areata involving 30-100% of the scalp. The researchers expect one third of these subjects to have concomitant alopecia areata (AA) and atopic dermatitis (AD).
The researchers' experience in AD, and past experience in psoriasis showed that biomarker studies in skin tissues are critical to the understanding of key pathogenic pathways that are upregulated in each disease and how well they are suppressed with effective treatment. These mechanistic studies coupled with clinical trials are key in the disease to shed light on important disease mechanisms, and to explain which molecules are suppressed by each therapeutic target. Data shows that IL-13 is significantly upregulated in both AD and AA lesions compared to nonlesional skin. It is very important to associate the clinical responses with suppression of this cytokine and related molecules as well as other pathway cytokines in skin tissues. Both the whole genomic profiling and individual molecular and cellular markers are very important in order to understand how well anti-IL-13 will change/suppress AA-associated pathways and compare with those that will be suppressed in AD.
Since this study is designed to gain basic knowledge rather than to yield information directly related to patient care, the results are not entered in the participants' medical records. If, at a later date, correlations of in-vitro tests and the patients' clinical situation suggest that the results do bear on the patients' health, an amended protocol will be submitted to the IRB so that results can be made available to the medical record.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Females of (FCBP) must have a negative pregnancy test at Screening and Baseline. While on 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 options described below:
Subject has a history of at least 6 months of moderate to severe AA (≥ 30% 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.
Subjects must meet the following laboratory criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An initial dupilumab dose of 600 mg (two 300 mg subcutaneous injections), followed by dupilumab 300 mg given every week
Drug: Dupilumab
Matching placebo in prefilled syringes identical to the dupilumab syringes
Drug: Placebo
A total of 24 doses
Also known as: Dupixent
A total of 24 doses
Also known as: matching placebo
Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 24
The SALT is a validated instrument for measuring the amount of scalp hair loss at a single point in time The SALT is a validated instrument for measuring the amount of scalp hair loss at a single point in time SALT - Scalp divided into four areas: vertex (40% of scalp surface area), right profile (18% of scalp surface area), left profile (18% of scalp surface area), and posterior scalp (24% of scalp surface area). Percentage of hair loss in these areas is multiplied by percent surface area of the scalp in that area. SALT score is the sum of percentage of hair loss in all areas. SALT scores range from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating better health outcomes/less hair loss. Primary Outcome is baseline minus Week 24 value.
Time frame: Baseline and 24 weeks
Change From Week 24 in the SALT Score at Week 48
SALT - Scalp divided into four areas: vertex (40% of scalp surface area), right profile (18% of scalp surface area), left profile (18% of scalp surface area), and posterior scalp (24% of scalp surface area). Percentage of hair loss in these areas is multiplied by percent surface area of the scalp in that area. SALT score is the sum of percentage of hair loss in all areas. Week 24 minus week 48 value.
Time frame: Week 24 and 48 weeks
Change From Baseline in the SALT Score at Week 48
Change in SALT score at Week 48 compared to Baseline. SALT - Scalp divided into four areas: vertex (40% of scalp surface area), right profile (18% of scalp surface area), left profile (18% of scalp surface area), and posterior scalp (24% of scalp surface area). Percentage of hair loss in these areas is multiplied by percent surface area of the scalp in that area. SALT score is the sum of percentage of hair loss in all areas. SALT scores range from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating better health outcomes/less hair loss. Baseline minus week 48 value.
Time frame: Baseline and 48 weeks
Number of Patients Achieving at Least 50% Improvement in Severity of Alopecia Tool (SALT) Score (SALT-50) at Weeks 24 and 48 Compared to Baseline
Number of subjects achieving SALT-50 score at Weeks 24 and 48 compared to Baseline. SALT - Scalp divided into four areas: vertex (40% of scalp surface area), right profile (18% of scalp surface area), left profile (18% of scalp surface area), and posterior scalp (24% of scalp surface area). Percentage of hair loss in these areas is multiplied by percent surface area of the scalp in that area. SALT score is the sum of percentage of hair loss SALT scores range from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating better health outcomes/less hair loss.in all areas.
Time frame: weeks 24 and 48
Number of Patients Achieving at Least 75% Improvement in SALT-75 at Weeks 24 and 48
Number of patients with Severity of Alopecia Tool (SALT) Score (SALT-75) (\> or equal to 75% improvement in SALT score) at Weeks 24 compared to Baseline. SALT - Scalp divided into four areas: vertex (40% of scalp surface area), right profile (18% of scalp surface area), left profile (18% of scalp surface area), and posterior scalp (24% of scalp surface area). Percentage of hair loss in these areas is multiplied by percent surface area of the scalp in that area. SALT score is the sum of percentage of hair loss in all areas. SALT scores range from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating better health outcomes/less hair loss.
Time frame: Weeks 24 and 48
Number of Patients Achieving at Least 90% Improvement in Severity of Alopecia Tool (SALT) Score (SALT-90) at Weeks 24 and 48
The number of patients achieving at least 90% improvement in Severity of Alopecia Tool (SALT) score (SALT-90) at Weeks 24, 48 compared to Baseline
Time frame: Weeks 24 and 48
Change in Alopecia Areata Symptom Impact Scale (AASIS)
Change in AASIS at Weeks 24 and 48 compared to Baseline. AASIS is a 13-item instrument, each item scored from 0 to 10 where higher scores correspond to worse symptom impact, full range from 0 to 130.
Time frame: Weeks 24 and 48
Change in Alopecia Areata Quality of Life Questionnaire
Change in the Alopecia Areata Quality of Life questionnaire (AA-QoL) at Weeks 24 and 48 compared to baseline. AAQoL is a 21-item instrument scored from 0 (poor) to 100 (good).
Time frame: Weeks 24 and 48
Eyelash/Eyebrow Assessment Score Weeks 12, 24, 36, and 48 Compared to Baseline
Change in eyelash and eyebrow scores at Weeks 12, 24, 36, and 48 compared to baseline. The Eyelash/Eyebrow Assessment score based on a 5-point scale, ranging from 0 (none) to 4 (very prominent eyelashes/eyebrows).
Time frame: Weeks 12, 24, 36, and 48
Change in EASI Scores From Baseline at Week 24 and 48
Change from baseline in Eczema Area and Severity Index (EASI) at Weeks 24 and 48. EASI scores range from 0 (no symptoms) to 72 (severe eczema) with lower score indicating better health outcomes/less eczema.
Time frame: Weeks 24 and 48
Number of Adverse Events
Safety profile of dupilumab in subjects with AA by reported adverse effects, physical examinations and laboratory parameters
Time frame: 48 weeks
| Milestone | Placebo Then Dupilumab | Dupilumab |
|---|---|---|
| Started | 20 | 40 |
| Completed | 20 | 40 |
| Not completed | 0 | 0 |
The SALT is a validated instrument for measuring the amount of scalp hair loss at a single point in time The SALT is a validated instrument for measuring the amount of scalp hair loss at a single point in time SALT - Scalp divided into four areas: vertex (40% of scalp surface area), right profile (18% of scalp surface area), left profile (18% of scalp surface area), and posterior scalp (24% of scalp surface area). Percentage of hair loss in these areas is multiplied by percent surface area of the scalp in that area. SALT score is the sum of percentage of hair loss in all areas. SALT scores range from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating better health outcomes/less hair loss. Primary Outcome is baseline minus Week 24 value.
| score on a scale | Placebo Then Dupilumab | Dupilumab |
|---|---|---|
| Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 24 | -6.3 ± 4.2 | 2.3 ± 3 |
SALT - Scalp divided into four areas: vertex (40% of scalp surface area), right profile (18% of scalp surface area), left profile (18% of scalp surface area), and posterior scalp (24% of scalp surface area). Percentage of hair loss in these areas is multiplied by percent surface area of the scalp in that area. SALT score is the sum of percentage of hair loss in all areas. Week 24 minus week 48 value.
| score on a scale | Placebo Then Dupilumab | Dupilumab |
|---|---|---|
| Change From Week 24 in the SALT Score at Week 48 | -6.3 ± 4.2 | 2.3 ± 3 |
Change in SALT score at Week 48 compared to Baseline. SALT - Scalp divided into four areas: vertex (40% of scalp surface area), right profile (18% of scalp surface area), left profile (18% of scalp surface area), and posterior scalp (24% of scalp surface area). Percentage of hair loss in these areas is multiplied by percent surface area of the scalp in that area. SALT score is the sum of percentage of hair loss in all areas. SALT scores range from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating better health outcomes/less hair loss. Baseline minus week 48 value.
| score on a scale | Placebo Then Dupilumab | Dupilumab |
|---|---|---|
| Change From Baseline in the SALT Score at Week 48 | -6.3 ± 4.2 | 2.3 ± 3 |
Number of subjects achieving SALT-50 score at Weeks 24 and 48 compared to Baseline. SALT - Scalp divided into four areas: vertex (40% of scalp surface area), right profile (18% of scalp surface area), left profile (18% of scalp surface area), and posterior scalp (24% of scalp surface area). Percentage of hair loss in these areas is multiplied by percent surface area of the scalp in that area. SALT score is the sum of percentage of hair loss SALT scores range from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating better health outcomes/less hair loss.in all areas.
| Participants | Placebo Then Dupilumab | Dupilumab |
|---|---|---|
| Week 24 | 0 | 4 |
| Week 48 | 3 | 9 |
Number of patients with Severity of Alopecia Tool (SALT) Score (SALT-75) (\> or equal to 75% improvement in SALT score) at Weeks 24 compared to Baseline. SALT - Scalp divided into four areas: vertex (40% of scalp surface area), right profile (18% of scalp surface area), left profile (18% of scalp surface area), and posterior scalp (24% of scalp surface area). Percentage of hair loss in these areas is multiplied by percent surface area of the scalp in that area. SALT score is the sum of percentage of hair loss in all areas. SALT scores range from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating better health outcomes/less hair loss.
| Participants | Placebo Then Dupilumab | Dupilumab |
|---|---|---|
| Week 24 | 0 | 2 |
| Week 48 | 1 | 6 |
The number of patients achieving at least 90% improvement in Severity of Alopecia Tool (SALT) score (SALT-90) at Weeks 24, 48 compared to Baseline
| Participants | Placebo Then Dupilumab | Dupilumab |
|---|---|---|
| Week 24 | 0 | 1 |
| Week 48 | 1 | 4 |
Change in AASIS at Weeks 24 and 48 compared to Baseline. AASIS is a 13-item instrument, each item scored from 0 to 10 where higher scores correspond to worse symptom impact, full range from 0 to 130.
| score on a scale | Placebo | Dupilumab |
|---|---|---|
| Week 24 | 10.25 ± 20.29 | 0.64 ± 22.27 |
| Week 48 | 22.6 ± 35.42 | 8.13 ± 27.65 |
Change in the Alopecia Areata Quality of Life questionnaire (AA-QoL) at Weeks 24 and 48 compared to baseline. AAQoL is a 21-item instrument scored from 0 (poor) to 100 (good).
| score on a scale | Placebo Then Dupilumab | Dupilumab |
|---|---|---|
| Week 24 | 4.29 ± 9.14 | 2.06 ± 8.49 |
| Week 48 | 22.6 ± 35.42 | 8.13 ± 27.65 |
Change in eyelash and eyebrow scores at Weeks 12, 24, 36, and 48 compared to baseline. The Eyelash/Eyebrow Assessment score based on a 5-point scale, ranging from 0 (none) to 4 (very prominent eyelashes/eyebrows).
| score on a scale | Placebo Then Dupilumab | Dupilumab |
|---|---|---|
| Eyelash Week 12 | 0 ± 0.37 | 0.07 ± 0.24 |
| Eyelash Week 24 | 0.37 ± 0.34 | 0.04 ± 0.24 |
| Eyelash Week 36 | -0.15 ± 0.37 | -0.06 ± 0.27 |
| Eyelash Week 48 | -0.17 ± 0.35 | 0.05 ± 0.26 |
| Eyebrow Week 12 | 0.09 ± 0.37 | 0.21 ± 0.25 |
| Eyebrow Week 24 | 0.27 ± 0.34 | 0.19 ± 0.24 |
| Eyebrow Week 36 | -0.2 ± 0.34 | 0.17 ± 0.24 |
| Eyebrow Week 48 | -0.03 ± 0.35 | 0.09 ± 0.25 |
Change from baseline in Eczema Area and Severity Index (EASI) at Weeks 24 and 48. EASI scores range from 0 (no symptoms) to 72 (severe eczema) with lower score indicating better health outcomes/less eczema.
| score on a scale | Placebo Then Dupilumab | Dupilumab |
|---|---|---|
| Week 24 | -1.45 ± 3.61 | 10.6 ± 3.64 |
| Week 48 | 23.9 ± 10.61 | 10.53 ± 3.75 |
Safety profile of dupilumab in subjects with AA by reported adverse effects, physical examinations and laboratory parameters
| events | Placebo Then Dupilumab | Dupilumab |
|---|---|---|
| Number of Adverse Events | 24 | 9 |
Collected over 48 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/20 (0%) | 0/20 (0%) | 4/20 (20%) |
| Dupilumab | 0/40 (0%) | 1/40 (2.5%) | 22/40 (55%) |
| Event | Placebo | Dupilumab |
|---|---|---|
| Bladder CancerRenal and urinary disorders | 0/20 | 1/40 |
| Event | Placebo | Dupilumab |
|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 2/20 | 6/40 |
| Other orthopedic injuries/proceduresMusculoskeletal and connective tissue disorders | 1/20 | 5/40 |
| ConjuctivitisSkin and subcutaneous tissue disorders | 0/20 | 4/40 |
| Gastrointestinal symptomsGastrointestinal disorders | 1/20 | 3/40 |
| Injection site reactionSkin and subcutaneous tissue disorders | 0/20 | 2/40 |
| FallGeneral disorders | 1/20 | 0/40 |
| Urinary tract infectionInfections and infestations | 0/20 | 2/40 |
| Oral herpesInfections and infestations | 1/20 | 0/40 |
| Eosinophilic dermatitisSkin and subcutaneous tissue disorders | 0/20 | 1/40 |
| FatigueGeneral disorders | 0/20 | 1/40 |
| Age, Continuous(years) | Placebo Then Dupilumab | Dupilumab | Total |
|---|---|---|---|
| Mean | 46.5 ± 14.4 | 41.6 ± 13.8 | 43 ± 13 |
| Sex: Female, Male(Participants) | Placebo Then Dupilumab | Dupilumab | Total |
|---|---|---|---|
| Female | 13 | 30 | 43 |
| Male | 7 | 10 | 17 |
| Race/Ethnicity, Customized(Participants) | Placebo Then Dupilumab | Dupilumab | Total |
|---|---|---|---|
| White | 15 | 31 | 46 |
| African American | 2 | 3 | 5 |
| Asian | 2 | 6 | 8 |
| Other | 1 | 0 | 1 |
| Duration since last hair regrowth(years) | Placebo Then Dupilumab | Dupilumab | Total |
|---|---|---|---|
| Mean | 3.5 ± 3 | 3.8 ± 2.9 | 3.6 ± 3 |
| Severity of alopecia tool (SALT)(units on a scale) | Placebo Then Dupilumab | Dupilumab | Total |
|---|---|---|---|
| Mean | 75.4 ± 26.1 | 70.5 ± 27.6 | 72.1 ± 27 |
| Patients with SALT>75(Participants) | Placebo Then Dupilumab | Dupilumab | Total |
|---|---|---|---|
| Count of participants | 12 | 20 | 32 |
| Patients with SALT<75(Participants) | Placebo Then Dupilumab | Dupilumab | Total |
|---|---|---|---|
| Count of participants | 8 | 20 | 28 |
| Patients with Alopecia Totalis/Universalis(Participants) | Placebo Then Dupilumab | Dupilumab | Total |
|---|---|---|---|
| Count of participants | 8 | 13 | 21 |
10 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Since this study is designed to gain basic knowledge rather than to yield information directly related to patient care, the results are not entered in the participants' medical records. If, at a later date, correlations of in-vitro tests and the patients' clinical situation suggest that the results do bear on the patients' health, an amended protocol will be submitted to the IRB so that results can be made available to the medical record.
Ran from Jan 2018 to primary completion in Jan 2020, 24 months.
Results were first posted in Feb 2022, 2 years 1 month after primary completion.
Of 30 phase 2 interventional studies under Alopecia Areata, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 35. This study's 24 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dupilumab
Icahn School of Medicine at Mount Sinai →