Clinical trial NCT06340360: A Phase 2b Study to Evaluate Rezpegaldesleukin (Rezpeg) in the Treatment of Severe to Very Severe Alopecia Areata in Adult Patients (Rezolve AA)
Official title: A Phase 2b, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rezpegaldesleukin in the Treatment of Severe to Very Severe Alopecia Areata in Adult Patients (Rezolve AA)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Alopecia Areata
Lead sponsor: Nektar Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-04-01
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to 1 of 3 groups (low dose, high dose, or placebo).
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Adults who are at least 18 years and ≤60 years for males (≤70 years of age for females) old at the time of informed consent
* Diagnosis of Alopecia Areata (AA) severity at screening and baseline:

  1. severe to very severe AA (≥ 50% scalp involvement) as measured using the SALT score
  2. Documented history over 6 months with no spontaneous improvement prior to baseline
  3. Current episode of severe to very severe AA of less than 8 years
* Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and baseline.
* While on investigational product and for at least 30 days after taking the last dose of investigational product (IP), WOCBP who engage in activity in which conception is possible must use approved highly effective contraceptive method(s). For male patient with partner that is WOCBP in which conception is possible, male patient must 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 Criteria:

* Men and women (of reproductive potential) unwilling to use birth control and women who 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:

  1. aldesleukin
  2. investigational IL-2 analog
  3. oral Janus kinase (JAK) inhibitor for any indication, including, but not limited to, baricitinib, upadacitinib, abrocitinib, tofacitinib, and ruxolitinib, whether marketed or investigational
  4. systemic immune-modulating biologic therapy (including, but not limited to, dupilumab, tralokinumab, lebrikizumab, nemolizumab, rocatinlimab, rituximab, ocrelizumab, ofatumumab, belimumab, daxdilimab, etc.) whether marketed or investigational
* History of cancer or lymphoproliferative disease within 5 years prior to Day 1. Note: Patients with successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma with no evidence of metastatic disease for 3 years and/or localized 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

Primary outcomes:
measure: Percent change from baseline in Severity of Alopecia Tool (SALT) score at Week 36
timeFrame: Baseline and Week 36
Secondary outcomes:
measure: Percent change from baseline in SALT score
timeFrame: Baseline and Weeks 12, 16, 20, 24, 28, and 32
measure: Proportion of patients achieving improvement in Severity of Alopecia Tool (SALT) ≥ 50%/75%/90%
timeFrame: Baseline and Weeks 12, 16, 20, 24, 28, 32, and 36
measure: Proportion of patients achieving an absolute SALT score ≤ 10/20/30/50
timeFrame: Baseline and Weeks 12, 16, 20, 24, 28, 32, and 36
Other outcomes:
Locations:
city: Northridge
country: United States
facility: Nektar Investigative Site
state: California
city: Atlanta
country: United States
facility: Nektar Investigative Site
state: Georgia
city: Gurnee
country: United States
facility: Nektar Investigative Site
state: Illinois
city: Indianapolis
country: United States
facility: Nektar Investigative Site
state: Indiana
city: Clinton Township
country: United States
facility: Nektar Investigative Site
state: Michigan
city: Portsmouth
country: United States
facility: Nektar Investigative Site
state: New Hampshire
city: New York
country: United States
facility: Nektar Investigative Site
state: New York
city: Camp Hill
country: United States
facility: Nektar Investigative Site
state: Pennsylvania
city: Frisco
country: United States
facility: Nektar Investigative Site
state: Texas
city: Pflugerville
country: United States
facility: Nektar Investigative Site
state: Texas
city: Surrey
country: Canada
facility: Nektar Investigative Site
state: British Columbia
city: Markham
country: Canada
facility: Nektar Investigative Site
state: Ontario
city: Oakville
country: Canada
facility: Nektar Investigative Site
state: Ontario
city: Richmond Hill
country: Canada
facility: Nektar Investigative Site
state: Ontario
city: Sherbrooke
country: Canada
facility: Nektar Investigative Site
state: Quebec
city: Wrocław
country: Poland
facility: Nektar Investigative Site
state: Dolnośląskie
city: Wrocław
country: Poland
facility: Nektar Investigative Site
state: Dolnośląskie
city: Wrocław
country: Poland
facility: Nektar Investigative Site
state: Dolnośląskie
city: Nowa Sól
country: Poland
facility: Nektar Investigative Site
state: Lubuskie
city: Warszawa
country: Poland
facility: Nektar Investigative Site
state: Mazowieckie
city: Warszawa
country: Poland
facility: Nektar Investigative Site
state: Mazowieckie
city: Rzeszów
country: Poland
facility: Nektar Investigative Site
state: Podkarpackie
city: Gdańsk
country: Poland
facility: Nektar Investigative Site
state: Pomorskie
city: Olsztyn
country: Poland
facility: Nektar Investigative Site
state: Warmińsko-mazurskie
city: Skórzewo
country: Poland
facility: Nektar Investigative Site
state: Wielkopolskie
city: Szczecin
country: Poland
facility: Nektar Investigative Site
state: Zachodniopomorskie
city: Katowice
country: Poland
facility: Nektar Investigative Site
state: Śląskie
city: Sosnowiec
country: Poland
facility: Nektar Investigative Site
state: Śląskie
Study officials:
affiliation: Nektar Therapeutics
name: Study Director
role: STUDY_DIRECTOR
References: