Alopecia Areata
Conditions
Keywords
alopecia, alopecia areata, alopecia universalis, alopecia totalis, dupixent, dupilumab
Brief summary
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.
Detailed description
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.
Interventions
DRUGDupilumab
A total of 24 doses
DRUGPlacebo
A total of 24 doses
Sponsors
Rockefeller University
Regeneron Pharmaceuticals
Sanofi
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * 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: 1. 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 2. 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. * 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 (≥ 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. 1. AT and AU will be limited to 50% of the total number of subjects enrolled. 2. One-third of subjects must have active AD skin or a concomitant history of AD at the time of the Screening and Baseline visits. * Subject has a negative Tuberculin purified protein derivative (PPD) or QuantiFERON TB-Gold test (QFT) prior to baseline. Subjects with a positive or indeterminable PPD or QFT result must have a documented negative workup for tuberculosis and/or completed standard tuberculosis therapy. * Subjects must meet the following laboratory criteria: 1. White blood cell count ≥ 3000/mm3 (≥ 3.0 x 109/L) and \< 14,000/mm3 (≤ 14 x 109/L). 2. Platelet count ≥ 100,000/μL (≥ 100 x 109/L). 3. Serum creatinine ≤ 1.5 mg/dL (≤ 132.6 μmol/L). 4. 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. 5. 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. 6. 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.
Exclusion criteria
* 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 ≥ 10 years since their last episode of hair loss. * Subject has an active bacterial, viral, or helminth parasitic infections; OR a history of ongoing, recurrent severe infections requiring systemic antibiotics * 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 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) within 12 weeks prior to the Baseline visit. * Subject has used topical corticosteroids, and/or tacrolimus, and/or pimecrolimus within 1 week before the Baseline visit. * Subject has been previously treated with dupilumab. * Subject currently uses or plans to use anti-retroviral therapy at any time during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 24 | Baseline and 24 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Week 24 in the SALT Score at Week 48 | Week 24 and 48 weeks | 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. |
| Change From Baseline in the SALT Score at Week 48 | Baseline and 48 weeks | 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. |
| 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 | weeks 24 and 48 | 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. |
| Number of Patients Achieving at Least 75% Improvement in SALT-75 at Weeks 24 and 48 | 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. |
| Number of Adverse Events | 48 weeks | Safety profile of dupilumab in subjects with AA by reported adverse effects, physical examinations and laboratory parameters |
| Change in Alopecia Areata Symptom Impact Scale (AASIS) | Weeks 24 and 48 | 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. |
| Change in Alopecia Areata Quality of Life Questionnaire | Weeks 24 and 48 | 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). |
| Eyelash/Eyebrow Assessment Score Weeks 12, 24, 36, and 48 Compared to Baseline | Weeks 12, 24, 36, and 48 | 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). |
| Change in EASI Scores From Baseline at Week 24 and 48 | Weeks 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. |
| Number of Patients Achieving at Least 90% Improvement in Severity of Alopecia Tool (SALT) Score (SALT-90) at Weeks 24 and 48 | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Then Dupilumab Matching placebo in prefilled syringes identical to the dupilumab syringes. After 24 weeks of Placebo, an initial dose of 600 mg Dupilumab (two 300 mg subcutaneous injections), followed by an open-label period in which 300 mg given every other week. A total of 24 Dupilumab doses. | 20 |
| Dupilumab An initial dose of 600 mg (two 300 mg subcutaneous injections), followed by 300 mg given every other week. A total of 48 Dupilumab doses will be given throughout the clinical trial, including 24 weeks during a randomized period and 24 weeks during an open label period. | 40 |
| Total | 60 |
Baseline characteristics
| Characteristic | Placebo Then Dupilumab | Dupilumab | Total |
|---|---|---|---|
| Age, Continuous | 46.5 years STANDARD_DEVIATION 14.4 | 41.6 years STANDARD_DEVIATION 13.8 | 43 years STANDARD_DEVIATION 13 |
| Alopecia Areata Quality of Life (AA-QoL) score | 51.75 units on a scale STANDARD_DEVIATION 13.88 | 49.49 units on a scale STANDARD_DEVIATION 12.56 | 50.25 units on a scale STANDARD_DEVIATION 13.1 |
| Alopecia Areata Symptom Impact Scale (AASIS) score | 56.1 units on a scale STANDARD_DEVIATION 32.86 | 48.42 units on a scale STANDARD_DEVIATION 30.27 | 50.9 units on a scale STANDARD_DEVIATION 31.33 |
| Duration since last hair regrowth | 3.5 years STANDARD_DEVIATION 3 | 3.8 years STANDARD_DEVIATION 2.9 | 3.6 years STANDARD_DEVIATION 3 |
| Eczema area and severity index (EASI) score | 27.4 units on a scale STANDARD_DEVIATION 11 | 13.58 units on a scale STANDARD_DEVIATION 5.68 | 17.53 units on a scale STANDARD_DEVIATION 9.83 |
| Eyebrow assessment Minimal | 8 Participants | 9 Participants | 17 Participants |
| Eyebrow assessment Moderate | 2 Participants | 6 Participants | 8 Participants |
| Eyebrow assessment None | 4 Participants | 10 Participants | 14 Participants |
| Eyebrow assessment Prominent | 0 Participants | 5 Participants | 5 Participants |
| Eyebrow assessment Very prominent | 6 Participants | 10 Participants | 16 Participants |
| Eyelash assessment Minimal | 6 Participants | 9 Participants | 15 Participants |
| Eyelash assessment Moderate | 1 Participants | 4 Participants | 5 Participants |
| Eyelash assessment None | 4 Participants | 9 Participants | 13 Participants |
| Eyelash assessment Prominent | 2 Participants | 6 Participants | 8 Participants |
| Eyelash assessment Very prominent | 6 Participants | 12 Participants | 18 Participants |
| IgE | 342.5 IU/ml STANDARD_DEVIATION 826.7 | 525.8 IU/ml STANDARD_DEVIATION 1211.3 | 464.7 IU/ml STANDARD_DEVIATION 1094 |
| Patients with active AD | 2 Participants | 5 Participants | 7 Participants |
| Patients with Alopecia Totalis/Universalis | 8 Participants | 13 Participants | 21 Participants |
| Patients with atopic dermatitis (AD) history | 6 Participants | 17 Participants | 23 Participants |
| Patients with family history of atopy | 9 Participants | 18 Participants | 27 Participants |
| Patients with IgE≥200 | 5 Participants | 13 Participants | 18 Participants |
| Patients with SALT<75 | 8 Participants | 20 Participants | 28 Participants |
| Patients with SALT>75 | 12 Participants | 20 Participants | 32 Participants |
| Race/Ethnicity, Customized African American | 2 Participants | 3 Participants | 5 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 6 Participants | 8 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 15 Participants | 31 Participants | 46 Participants |
| Severity of alopecia tool (SALT) | 75.4 units on a scale STANDARD_DEVIATION 26.1 | 70.5 units on a scale STANDARD_DEVIATION 27.6 | 72.1 units on a scale STANDARD_DEVIATION 27 |
| Sex: Female, Male Female | 13 Participants | 30 Participants | 43 Participants |
| Sex: Female, Male Male | 7 Participants | 10 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 40 |
| other Total, other adverse events | 4 / 20 | 22 / 40 |
| serious Total, serious adverse events | 0 / 20 | 1 / 40 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Then Dupilumab | Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 24 | -6.3 score on a scale | Standard Deviation 4.2 |
| Dupilumab | Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 24 | 2.3 score on a scale | Standard Deviation 3 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Then Dupilumab | Change From Baseline in the SALT Score at Week 48 | -6.3 score on a scale | Standard Error 4.2 |
| Dupilumab | Change From Baseline in the SALT Score at Week 48 | 2.3 score on a scale | Standard Error 3 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Then Dupilumab | Change From Week 24 in the SALT Score at Week 48 | -6.3 score on a scale | Standard Error 4.2 |
| Dupilumab | Change From Week 24 in the SALT Score at Week 48 | 2.3 score on a scale | Standard Error 3 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Then Dupilumab | Change in Alopecia Areata Quality of Life Questionnaire | Week 48 | 22.6 score on a scale | Standard Error 35.42 |
| Placebo Then Dupilumab | Change in Alopecia Areata Quality of Life Questionnaire | Week 24 | 4.29 score on a scale | Standard Error 9.14 |
| Dupilumab | Change in Alopecia Areata Quality of Life Questionnaire | Week 24 | 2.06 score on a scale | Standard Error 8.49 |
| Dupilumab | Change in Alopecia Areata Quality of Life Questionnaire | Week 48 | 8.13 score on a scale | Standard Error 27.65 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Then Dupilumab | Change in Alopecia Areata Symptom Impact Scale (AASIS) | Week 24 | 10.25 score on a scale | Standard Error 20.29 |
| Placebo Then Dupilumab | Change in Alopecia Areata Symptom Impact Scale (AASIS) | Week 48 | 22.6 score on a scale | Standard Error 35.42 |
| Dupilumab | Change in Alopecia Areata Symptom Impact Scale (AASIS) | Week 24 | 0.64 score on a scale | Standard Error 22.27 |
| Dupilumab | Change in Alopecia Areata Symptom Impact Scale (AASIS) | Week 48 | 8.13 score on a scale | Standard Error 27.65 |
Secondary
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
Population: Data for only those participants with eczema.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Then Dupilumab | Change in EASI Scores From Baseline at Week 24 and 48 | Week 24 | -1.45 score on a scale | Standard Error 3.61 |
| Placebo Then Dupilumab | Change in EASI Scores From Baseline at Week 24 and 48 | Week 48 | 23.9 score on a scale | Standard Error 10.61 |
| Dupilumab | Change in EASI Scores From Baseline at Week 24 and 48 | Week 24 | 10.6 score on a scale | Standard Error 3.64 |
| Dupilumab | Change in EASI Scores From Baseline at Week 24 and 48 | Week 48 | 10.53 score on a scale | Standard Error 3.75 |
Secondary
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
Population: One participant had missing eyelash data because of artificial eyelashes (glued on her real eyelashes).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Then Dupilumab | Eyelash/Eyebrow Assessment Score Weeks 12, 24, 36, and 48 Compared to Baseline | Eyelash Week 36 | -0.15 score on a scale | Standard Error 0.37 |
| Placebo Then Dupilumab | Eyelash/Eyebrow Assessment Score Weeks 12, 24, 36, and 48 Compared to Baseline | Eyebrow Week 24 | 0.27 score on a scale | Standard Error 0.34 |
| Placebo Then Dupilumab | Eyelash/Eyebrow Assessment Score Weeks 12, 24, 36, and 48 Compared to Baseline | Eyebrow Week 48 | -0.03 score on a scale | Standard Error 0.35 |
| Placebo Then Dupilumab | Eyelash/Eyebrow Assessment Score Weeks 12, 24, 36, and 48 Compared to Baseline | Eyelash Week 12 | 0 score on a scale | Standard Error 0.37 |
| Placebo Then Dupilumab | Eyelash/Eyebrow Assessment Score Weeks 12, 24, 36, and 48 Compared to Baseline | Eyelash Week 24 | 0.37 score on a scale | Standard Error 0.34 |
| Placebo Then Dupilumab | Eyelash/Eyebrow Assessment Score Weeks 12, 24, 36, and 48 Compared to Baseline | Eyelash Week 48 | -0.17 score on a scale | Standard Error 0.35 |
| Placebo Then Dupilumab | Eyelash/Eyebrow Assessment Score Weeks 12, 24, 36, and 48 Compared to Baseline | Eyebrow Week 12 | 0.09 score on a scale | Standard Error 0.37 |
| Placebo Then Dupilumab | Eyelash/Eyebrow Assessment Score Weeks 12, 24, 36, and 48 Compared to Baseline | Eyebrow Week 36 | -0.2 score on a scale | Standard Error 0.34 |
| Dupilumab | Eyelash/Eyebrow Assessment Score Weeks 12, 24, 36, and 48 Compared to Baseline | Eyelash Week 48 | 0.05 score on a scale | Standard Error 0.26 |
| Dupilumab | Eyelash/Eyebrow Assessment Score Weeks 12, 24, 36, and 48 Compared to Baseline | Eyebrow Week 12 | 0.21 score on a scale | Standard Error 0.25 |
| Dupilumab | Eyelash/Eyebrow Assessment Score Weeks 12, 24, 36, and 48 Compared to Baseline | Eyelash Week 24 | 0.04 score on a scale | Standard Error 0.24 |
| Dupilumab | Eyelash/Eyebrow Assessment Score Weeks 12, 24, 36, and 48 Compared to Baseline | Eyebrow Week 24 | 0.19 score on a scale | Standard Error 0.24 |
| Dupilumab | Eyelash/Eyebrow Assessment Score Weeks 12, 24, 36, and 48 Compared to Baseline | Eyelash Week 36 | -0.06 score on a scale | Standard Error 0.27 |
| Dupilumab | Eyelash/Eyebrow Assessment Score Weeks 12, 24, 36, and 48 Compared to Baseline | Eyebrow Week 48 | 0.09 score on a scale | Standard Error 0.25 |
| Dupilumab | Eyelash/Eyebrow Assessment Score Weeks 12, 24, 36, and 48 Compared to Baseline | Eyebrow Week 36 | 0.17 score on a scale | Standard Error 0.24 |
| Dupilumab | Eyelash/Eyebrow Assessment Score Weeks 12, 24, 36, and 48 Compared to Baseline | Eyelash Week 12 | 0.07 score on a scale | Standard Error 0.24 |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Then Dupilumab | Number of Adverse Events | 24 events |
| Dupilumab | Number of Adverse Events | 9 events |
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo Then Dupilumab | 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 | Week 24 | 0 Participants |
| Placebo Then Dupilumab | 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 | Week 48 | 3 Participants |
| Dupilumab | 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 | Week 48 | 9 Participants |
| Dupilumab | 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 | Week 24 | 4 Participants |
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo Then Dupilumab | Number of Patients Achieving at Least 75% Improvement in SALT-75 at Weeks 24 and 48 | Week 24 | 0 Participants |
| Placebo Then Dupilumab | Number of Patients Achieving at Least 75% Improvement in SALT-75 at Weeks 24 and 48 | Week 48 | 1 Participants |
| Dupilumab | Number of Patients Achieving at Least 75% Improvement in SALT-75 at Weeks 24 and 48 | Week 48 | 6 Participants |
| Dupilumab | Number of Patients Achieving at Least 75% Improvement in SALT-75 at Weeks 24 and 48 | Week 24 | 2 Participants |
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo Then Dupilumab | Number of Patients Achieving at Least 90% Improvement in Severity of Alopecia Tool (SALT) Score (SALT-90) at Weeks 24 and 48 | Week 24 | 0 Participants |
| Placebo Then Dupilumab | Number of Patients Achieving at Least 90% Improvement in Severity of Alopecia Tool (SALT) Score (SALT-90) at Weeks 24 and 48 | Week 48 | 1 Participants |
| Dupilumab | Number of Patients Achieving at Least 90% Improvement in Severity of Alopecia Tool (SALT) Score (SALT-90) at Weeks 24 and 48 | Week 24 | 1 Participants |
| Dupilumab | Number of Patients Achieving at Least 90% Improvement in Severity of Alopecia Tool (SALT) Score (SALT-90) at Weeks 24 and 48 | Week 48 | 4 Participants |