Alopecia Areata
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Alopecia Areata
23-358-06 Enrolling

Severe Alopecia Areata Research Trial (65 Weeks)


Treatment: Injection Age: 18 Years


Who Can Participate?

Adults women (18-70 years) and and adult men (18-60 years) with a diagnosis of severe or very severe alopecia areata (AA) may participate.

 Inclusion Criteria

  • Have hair loss from alopecia areata affecting more than 50% of the scalp
  • Be experiencing an episode that has lasted less than 8 years
  • Have stable amount of hair loss over the last 6 months

What Are The Benefits?

  • Study treatment, visits, tests, and procedures will be provided at no cost to you
  • Regular visits with study doctors who specialise in treating AA (24 visits)
  • Will receive a subcutaneous injection of the investigative treatment (study drug) or a placebo
  • Reimbursement for study-related expenses may be available

How Long Will The Study Last?

  • 65 weeks

Note: Participants may not be engaged in any other kind of systemic, topical, or device-based therapy for AA. Other eligibility criteria apply. The study staff will provide more details about any reimbursement for travel related expenses or compensation that may be available.


Participating Locations

COUNTRY
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Canada

Participating Experts

Dr. Charles Lynde

Dermatologist

Dr. Sheetal Sapra

Dermatologist

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The following information is from ClinicalTrials.gov

Last Update Posted: May 19, 2024

Official Title

A Phase 2b, Randomized, Double-Blind, Parallel Group, Placebo-Controlled 60-Week Study to Evaluate the Efficacy and Safety of Rezpegaldesleukin in the Treatment of Severe to Very Severe Alopecia Areata in Adult Patients (Rezolve AA)

ClinicalTrials.gov ID

NCT06340360

Sponsor

Nektar Therapeutics

Study Description

  • 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, and a 24-week follow-up period. The maximum study duration is approximately 65 weeks for all participants.

  • Condition or Disease:

    Alopecia Areata

  • Intervention/Treatment:

    Drug: Rezpegaldesleukin
    Drug: Rezpegaldesleukin
    Drug: Placebo
  • Phase:

    Phase 2

  • Ages Eligible for Study:

    18 Years and 70 Years (Adult)

  • Sexes Eligible for Study:

    All

Inclusion Criteria:

Adults who are at least 18 years ≤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:

severe to very severe AA (≥ 50% scalp involvement) as measured using the SALT score
Documented history over 6 months with no spontaneous improvement prior to baseline
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 contraceptive method(s). For male patient with partner that is WOCBP in which conception is possible, male patient must agree to use approved 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

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:

aldesleukin
investigational IL-2 analog
oral Janus kinase (JAK) inhibitor for any indication, including, but not limited to, baricitinib, upadacitinib, abrocitinib, tofacitinib, and ruxolitinib, 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 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.
Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C at screening.
Other skin conditions that would interfere with study assessments of AA


Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.



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