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New drug aims to regrow hair in severe baldness disorder

NCT ID NCT06340360

Disease control Sponsor: Nektar Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 2 times

Summary

This study tests an experimental drug called rezpegaldesleukin in 94 adults with severe to very severe alopecia areata, a condition causing significant hair loss. Participants receive either the drug or a placebo for 36 weeks, with an optional extension. The main goal is to measure hair regrowth using a standard scalp scoring system.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

94 people

The number who actually took part.

Started

Apr 2024

Finished

Aug 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

alopecia areata

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alopecia areata

Contacts and locations

Locations

  • Nektar Investigative Site

    Northridge, California, 91324, United States

  • Nektar Investigative Site

    Atlanta, Georgia, 30331, United States

  • Nektar Investigative Site

    Gurnee, Illinois, 60031, United States

  • Nektar Investigative Site

    Indianapolis, Indiana, 46202, United States

  • Nektar Investigative Site

    Clinton Township, Michigan, 48038, United States

  • Nektar Investigative Site

    Portsmouth, New Hampshire, 03801, United States

  • Nektar Investigative Site

    New York, New York, 10075, United States

  • Nektar Investigative Site

    Camp Hill, Pennsylvania, 17011, United States

  • Nektar Investigative Site

    Frisco, Texas, 75034, United States

  • Nektar Investigative Site

    Pflugerville, Texas, 78660, United States

  • Nektar Investigative Site

    Surrey, British Columbia, V3V 0C6, Canada

  • Nektar Investigative Site

    Markham, Ontario, L3P 1X3, Canada

  • Nektar Investigative Site

    Oakville, Ontario, L6J 7W5, Canada

  • Nektar Investigative Site

    Richmond Hill, Ontario, L4B 1A5, Canada

  • Nektar Investigative Site

    Sherbrooke, Quebec, J1G 1X9, Canada

  • Nektar Investigative Site

    Wroclaw, Lower Silesian Voivodeship, 50-450, Poland

  • Nektar Investigative Site

    Wroclaw, Lower Silesian Voivodeship, 50-566, Poland

  • Nektar Investigative Site

    Wroclaw, Lower Silesian Voivodeship, 51-685, Poland

  • Nektar Investigative Site

    Nowa Sól, Lubusz Voivodeship, 67-100, Poland

  • Nektar Investigative Site

    Warsaw, Masovian Voivodeship, 02-482, Poland

  • Nektar Investigative Site

    Warsaw, Masovian Voivodeship, 02-953, Poland

  • Nektar Investigative Site

    Gdansk, Pomeranian Voivodeship, 80-546, Poland

  • Nektar Investigative Site

    Katowice, Silesian Voivodeship, 40-611, Poland

  • Nektar Investigative Site

    Sosnowiec, Silesian Voivodeship, 41-200, Poland

  • Nektar Investigative Site

    Olsztyn, Warmian-Masurian Voivodeship, 10-229, Poland

  • Nektar Investigative Site

    Szczecin, West Pomeranian Voivodeship, 71-500, Poland

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