A Phase 2b Study to Evaluate Rezpegaldesleukin (Rezpeg) in the Treatment of Severe to Very Severe Alopecia Areata in Adult Patients (Rezolve AA) (Rezolve AA)
D
David Rosmarin
Primary Investigator
Recruiting
18-70 years
All
Phase
1/2
5 participants needed
1 Location
Brief description of study
Why is this study being done?
This study is being done to evaluate the efficacy (how well the drug works), and safety, of rezpegaldesleukin (REZPEG) at different dose levels, as compared to placebo, in adults with severe to very severe Alopecia Areata (AA), and to choose the best dose of REZPEG. AA is a condition characterized by the loss of hair in small patches. The condition develops when the immune system attacks hair follicles, causing hair loss on the scalp, face, and sometimes on other body areas.
REZPEG is an investigational (experimental) drug. Investigational means that REZPEG is being tested and has not been approved by Health Canada or the United States (US) Food and Drug Administration to treat AA or other diseases. The placebo is a saltwater (saline) solution that looks like REZPEG but contains no drug or active ingredients. In this form, both REZPEG and placebo are called “study drug”.
In this research study, study drug will be given as an injection directly under your skin. Different doses of REZPEG will be compared to placebo to see if REZPEG helps in reducing hair loss and improves other signs and symptoms of AA.
Who can take part?
Males (ages 18-60) and females (ages 18-70) who have severe to very severe Alopecia Areata (AA).
Additional information
The study is being conducted by David Rosmarin, MD at Indiana University School of Medicine Dermatology. Nektar Therapeutics (called the Sponsor in this form), a biopharmaceutical company, is the Sponsor of this study. The Sponsor makes REZPEG and is paying the study site for their work on this study.
The study is being conducted by David Rosmarin, MD at Indiana University School of Medicine Dermatology. Nektar Therapeutics (called the Sponsor in this form), a biopharmaceutical company, is the Sponsor of this study. The Sponsor makes REZPEG and is paying the study site for their work on this study.
Detailed description of study
What will happen during the study?
If you choose to take part in this study, you will be randomly assigned, like the flip of a coin, to receive either the study drug REZPEG or placebo every two weeks for 36 weeks as an injection. Your participation in the study is expected to last for up to 65 weeks. This will involve visiting the study site about 24 times in total.
The study has 3 periods:
The study has 3 periods:
- Screening Period: up to 35 days
- Study Treatment Period: 36 weeks
- Follow-Up Period: 24 weeks
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Alopecia Areata, AA
-
Age: Between 18 Years - 70 Years
-
Gender: All
Inclusion Criteria
In order to be eligible to participate in this study, a patient must meet all of the following criteria,
either at the screening and Day 1 visits or only at 1 of the specified visits (screening or Day 1) as
noted in the criterion:
1. Adult patient, at least 18 years and ≤60 years for males (≤70 years of age for females) at the time of consent.
2. Patient willing to keep the same hair style and color (eg, hair products, process, and timing for hair appointments)
In order to be eligible to participate in this study, a patient must meet all of the following criteria,
either at the screening and Day 1 visits or only at 1 of the specified visits (screening or Day 1) as
noted in the criterion:
1. Adult patient, at least 18 years and ≤60 years for males (≤70 years of age for females) at the time of consent.
2. Patient willing to keep the same hair style and color (eg, hair products, process, and timing for hair appointments)
for the duration of the trial.
3. Patient has clinical diagnosis of severe to very severe AA defined as:
a) ≥ 50% total scalp hair loss at screening and baseline (Day 1) as measured by the SALT
score.
b) no spontaneous improvement over the past 6 months prior to Day 1 (information
obtained from medical chart or patient’s physician, or directly from the patient; an
example would be no more than 10-point spontaneous reduction in SALT)
c) current episode of severe or very severe AA of less than 8 years.
4. Female of childbearing potential must have a negative serum pregnancy test at screening
and negative urine pregnancy test at Day 1.
5. For female patient of childbearing potential involved in any sexual intercourse that could
lead to pregnancy: the patient must agree to use a contraceptive method as detailed in APPENDIX I.
3. Patient has clinical diagnosis of severe to very severe AA defined as:
a) ≥ 50% total scalp hair loss at screening and baseline (Day 1) as measured by the SALT
score.
b) no spontaneous improvement over the past 6 months prior to Day 1 (information
obtained from medical chart or patient’s physician, or directly from the patient; an
example would be no more than 10-point spontaneous reduction in SALT)
c) current episode of severe or very severe AA of less than 8 years.
4. Female of childbearing potential must have a negative serum pregnancy test at screening
and negative urine pregnancy test at Day 1.
5. For female patient of childbearing potential involved in any sexual intercourse that could
lead to pregnancy: the patient must agree to use a contraceptive method as detailed in APPENDIX I.
6. For male patient involved in any sexual intercourse that could lead to pregnancy, patient
must agree to use a contraceptive method as detailed in APPENDIX I.
7. Patient has had negative tuberculosis (TB) infection tests. Patient will be evaluated for
latent TB infection with a QuantiFERON-TB Gold test. A purified protein derivative (PPD)
test could also be done if a QuantiFERON-TB Gold test is not possible or based on local
requirements. Patients who demonstrate evidence of latent TB infection (either PPD
≥ 5 mm of induration or positive QuantiFERON-TB Gold test, irrespective of bacille
must agree to use a contraceptive method as detailed in APPENDIX I.
7. Patient has had negative tuberculosis (TB) infection tests. Patient will be evaluated for
latent TB infection with a QuantiFERON-TB Gold test. A purified protein derivative (PPD)
test could also be done if a QuantiFERON-TB Gold test is not possible or based on local
requirements. Patients who demonstrate evidence of latent TB infection (either PPD
≥ 5 mm of induration or positive QuantiFERON-TB Gold test, irrespective of bacille
Calmette-Guérin vaccination status will not be allowed to participate in the study
8. Patient is willing to participate and is capable of giving informed consent.
Note: Consent must be obtained prior to any study-related procedures.
9. Patients must be willing and able to comply with all study procedures and must be available for the duration of the study.
8. Patient is willing to participate and is capable of giving informed consent.
Note: Consent must be obtained prior to any study-related procedures.
9. Patients must be willing and able to comply with all study procedures and must be available for the duration of the study.
Updated on
11 Sep 2024.
Study ID: DERM-NEKTAR-23-358-06, 22895
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