Phase
Condition
Alopecia
Hair Loss
Treatment
Rezpegaldesleukin
Placebo
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adults who are at least 18 years and ≤60 years for males (≤70 years of age forfemales) old at the time of informed consent
Diagnosis of Alopecia Areata (AA) severity at screening and baseline:
severe to very severe AA (≥ 50% scalp involvement) as measured using the SALTscore
Documented history over 6 months with no spontaneous improvement prior tobaseline
Current episode of severe to very severe AA of less than 8 years
Women of childbearing potential (WOCBP) must have a negative pregnancy test atscreening and baseline.
While on investigational product and for at least 30 days after taking the last doseof investigational product (IP), WOCBP who engage in activity in which conception ispossible must use approved highly effective contraceptive method(s). For malepatient with partner that is WOCBP in which conception is possible, male patientmust agree to use approved highly effective contraceptive method(s).
Able to complete patient questionnaires
Able and willing to comply with requested study visits and procedures
Able and willing to provide written informed consent
Able to communicate, read and/or understand the local language
Exclusion
Exclusion Criteria:
Men and women (of reproductive potential) unwilling to use birth control and womenwho are pregnant or breastfeeding.
Patient has primarily "diffuse" type AA (characterized by diffuse hair shedding).
Presence of another form of alopecia.
Prior use of any of the following treatments:
aldesleukin
investigational IL-2 analog
oral Janus kinase (JAK) inhibitor for any indication, including, but notlimited to, baricitinib, upadacitinib, abrocitinib, tofacitinib, andruxolitinib, whether marketed or investigational
systemic immune-modulating biologic therapy (including, but not limited to,dupilumab, tralokinumab, lebrikizumab, nemolizumab, rocatinlimab, rituximab,ocrelizumab, ofatumumab, belimumab, daxdilimab, etc.) whether marketed orinvestigational
History of cancer or lymphoproliferative disease within 5 years prior to Day 1.Note: Patients with successfully treated nonmetastatic cutaneous squamous cell orbasal cell carcinoma with no evidence of metastatic disease for 3 years and/orlocalized carcinoma in situ of the cervix with no evidence of recurrence within the 3 years prior to Day 1 are not to be excluded.
Current infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV),or hepatitis C virus (HCV) at screening.
Other skin conditions that would interfere with study assessments of AA
Study Design
Connect with a study center
Enverus Medical Research
Surrey, British Columbia V3V 0C6
CanadaActive - Recruiting
Nektar Investigative Site
Surrey, British Columbia V3V 0C6
CanadaSite Not Available
Lynderm Research Inc
Markham, Ontario L3P 1X3
CanadaActive - Recruiting
Nektar Investigative Site
Markham, Ontario L3P 1X3
CanadaSite Not Available
Nektar Investigative Site
Oakville, Ontario L6J 7W5
CanadaSite Not Available
The Centre for Clinical Trials
Oakville, Ontario L6J 7W5
CanadaActive - Recruiting
Nektar Investigative Site
Richmond Hill, Ontario L4B 1A5
CanadaSite Not Available
The Centre for Dermatology
Richmond Hill, Ontario L4B 1A5
CanadaActive - Recruiting
Centre de Recherche Saint-Louis SHERBROOKE
Sherbrooke, Quebec J1G 1X9
CanadaActive - Recruiting
Nektar Investigative Site
Sherbrooke, Quebec J1G 1X9
CanadaSite Not Available
Nektar Investigative Site
Wrocław, Dolnośląskie 51-685
PolandSite Not Available
Nektar Investigative Site
Nowa Sól, Lubuskie 67-100
PolandSite Not Available
Nektar Investigative Site
Warszawa, Mazowieckie 02-482
PolandSite Not Available
Nektar Investigative Site
Rzeszów, Podkarpackie 35-055
PolandSite Not Available
Nektar Investigative Site
Gdańsk, Pomorskie 80-546
PolandSite Not Available
Nektar Investigative Site
Olsztyn, Warmińsko-mazurskie 10-229
PolandSite Not Available
Nektar Investigative Site
Skórzewo, Wielkopolskie 60-185
PolandSite Not Available
Nektar Investigative Site
Szczecin, Zachodniopomorskie 71-500
PolandSite Not Available
Nektar Investigative Site
Katowice, Śląskie 40-611
PolandSite Not Available
Nektar Investigative Site
Sosnowiec, Śląskie 41-200
PolandSite Not Available
Nektar Investigative Site
Northridge, California 91324
United StatesSite Not Available
Quest Dermatology Research
Northridge, California 91324
United StatesActive - Recruiting
Atlanta Biomedical Clinical Research
Atlanta, Georgia 30331
United StatesActive - Recruiting
Nektar Investigative Site
Atlanta, Georgia 30331
United StatesSite Not Available
Clinical Investigation Specialists, Inc.
Gurnee, Illinois 60031
United StatesActive - Recruiting
Nektar Investigative Site
Gurnee, Illinois 60031
United StatesSite Not Available
Indiana Clinical and Translational Sciences Institute (CTSI) Clinical Research Center
Indianapolis, Indiana 46202
United StatesSite Not Available
Nektar Investigative Site
Indianapolis, Indiana 46202
United StatesSite Not Available
Michigan Center for Skin Care Research
Clinton Township, Michigan 48038
United StatesActive - Recruiting
Nektar Investigative Site
Clinton Township, Michigan 48038
United StatesSite Not Available
ALLCUTIS Research, LLC.
Portsmouth, New Hampshire 03801
United StatesActive - Recruiting
Nektar Investigative Site
Portsmouth, New Hampshire 03801
United StatesSite Not Available
Nektar Investigative Site
New York, New York 10075
United StatesSite Not Available
Sadick Research Group LLC
New York, New York 10075
United StatesActive - Recruiting
DermDox Centers for Dermatology
Camp Hill, Pennsylvania 17011
United StatesActive - Recruiting
Nektar Investigative Site
Camp Hill, Pennsylvania 17011
United StatesSite Not Available
Nektar Investigative Site
Frisco, Texas 75034
United StatesSite Not Available
North Texas Center for Clinical Research
Frisco, Texas 75034
United StatesActive - Recruiting
Austin Institute for Clinical Research
Pflugerville, Texas 786660
United StatesActive - Recruiting
Nektar Investigative Site
Pflugerville, Texas 78660
United StatesSite Not Available
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