This is an interventional, randomized, double blind, parallel group, placebo-controlled, Phase 2b, 3-arm study to assess the effect of pegylated-recombinant-human interleukin-2 (rezpegaldesleukin) in adult participants with severe to very severe alopecia areata. The estimated duration includes a screening period of up to 35 days, a 36-week treatment period, an optional 16-week treatment extension period, and a 24-week follow-up period. The maximum study duration is approximately 81 weeks for all participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
94
Pharmaceutical form: Injection solution Route of administration: subcutaneous
Pharmaceutical form: Injection solution Route of administration: subcutaneous
Nektar Investigative Site
Northridge, California, United States
Nektar Investigative Site
Atlanta, Georgia, United States
Nektar Investigative Site
Gurnee, Illinois, United States
Nektar Investigative Site
Indianapolis, Indiana, United States
Nektar Investigative Site
Clinton Township, Michigan, United States
Nektar Investigative Site
Portsmouth, New Hampshire, United States
Nektar Investigative Site
New York, New York, United States
Nektar Investigative Site
Camp Hill, Pennsylvania, United States
Nektar Investigative Site
Frisco, Texas, United States
Nektar Investigative Site
Pflugerville, Texas, United States
...and 16 more locations
Percent change from baseline in Severity of Alopecia Tool (SALT) score at Week 36
The SALT score is the sum of percentage of hair loss in all areas with a maximum score of 100 (higher score indicates greater hair loss).
Time frame: Baseline and Week 36
Percent change from baseline in SALT score
SALT score is the sum of percentage of hair loss in all areas with a maximum score of 100 (higher score indicates greater hair loss).
Time frame: Baseline and Weeks 12, 16, 20, 24, 28, and 32
Proportion of patients achieving improvement in Severity of Alopecia Tool (SALT) ≥ 50%/75%/90%
Proportion of patients achieving improvement of ≥ 50%/75%/90% in Severity of Alopecia Tool (SALT) relative to their baseline score (SALT50/75/90). SALT score is the sum of percentage of hair loss in all areas with a maximum score of 100 (higher score indicates greater hair loss).
Time frame: Baseline and Weeks 12, 16, 20, 24, 28, 32, and 36
Proportion of patients achieving an absolute SALT score ≤ 10/20/30/50
Proportion of patients achieving an absolute SALT score of ≤ 10/20/30/50. 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 ≤ 10/20/30/50 will be calculated.
Time frame: Baseline and Weeks 12, 16, 20, 24, 28, 32, and 36
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