Rezpegaldesleukin for Alopecia Areata

Not currently recruiting at 42 trial locations

Overseen By Sohail Chaudhry

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Nektar Therapeutics

Must not be taking: JAK inhibitors, Biologics

Disqualifiers: Diffuse AA, Other alopecia, Cancer, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 18

Duration: 36 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new treatment called rezpegaldesleukin for individuals with severe to very severe alopecia areata, a condition that causes hair loss. Researchers seek to determine if this treatment can promote hair regrowth and improve scalp health. Participants will receive either a high dose, low dose, or a placebo (a harmless pill with no active ingredients) every two weeks. The trial seeks adults who have experienced significant hair loss for at least six months but less than eight years. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you have used certain treatments like aldesleukin, investigational IL-2 analogs, oral JAK inhibitors, or systemic immune-modulating biologic therapies, you may not be eligible to participate.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, if you have used certain treatments like oral JAK inhibitors or systemic immune-modulating biologic therapies, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that rezpegaldesleukin has a good safety record from earlier studies. In trials involving individuals with moderate to severe atopic dermatitis (a type of skin inflammation), the treatment was generally well-tolerated. These studies also included healthy volunteers and individuals with chronic inflammation, enhancing the safety information.

Most participants did not experience major side effects. When side effects occurred, they were usually mild, such as skin reactions at the injection site. The treatment has not been linked to any serious health problems in the available data.

Notably, the FDA has granted rezpegaldesleukin Fast Track status for treating severe alopecia areata. This often indicates that the FDA sees potential benefits and a reasonable safety profile based on early data. However, as this study continues, researchers will monitor safety to ensure the treatment remains well-tolerated. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for alopecia areata?

Most treatments for alopecia areata focus on suppressing the immune system or stimulating hair growth. But Rezpegaldesleukin works differently, targeting the immune system more precisely by modulating specific interleukins involved in inflammation. This new mechanism of action could potentially offer a more tailored approach with fewer side effects compared to traditional therapies like corticosteroids or JAK inhibitors. Researchers are excited because this precision could lead to more effective treatments for patients with fewer unwanted effects.

What evidence suggests that rezpegaldesleukin might be an effective treatment for alopecia areata?

Studies have shown that rezpegaldesleukin may help treat severe alopecia areata, a condition that causes hair loss. Research suggests this treatment works by boosting the number of Tregs, immune cells that help control the immune system. Participants in this trial will receive either a high dose or a low dose of rezpegaldesleukin, or a placebo. Other studies have shown that high doses of rezpegaldesleukin achieved important goals and showed promising results in patients with similar conditions like atopic dermatitis. Additionally, the FDA has granted this treatment Fast Track status, indicating its potential benefits. These findings suggest that rezpegaldesleukin could be a promising option for people with severe alopecia areata. ^{1 2 3 6 7}

Who Is on the Research Team?

Study Director

Principal Investigator

Nektar Therapeutics

Are You a Good Fit for This Trial?

This clinical trial is for adults with severe to very severe alopecia areata. Participants must complete a screening, undergo treatment for 36 weeks, and participate in follow-up for another 24 weeks. Specific eligibility criteria details were not provided.

Inclusion Criteria

I am a woman who can have children and have tested negative for pregnancy.

Able and willing to comply with requested study visits and procedures

My alopecia areata is severe, affecting more than half of my scalp.

Exclusion Criteria

I do not have skin conditions affecting AA study assessments.

Presence of another form of alopecia

Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C at screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

5 weeks

Treatment

Participants receive either Rezpegaldesleukin or placebo every 2 weeks for 36 weeks

36 weeks

18 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

Treatment Extension (optional)

Participants may opt into an additional 16-week treatment extension period

16 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Rezpegaldesleukin

Trial Overview

The study tests Rezpegaldesleukin (Rezpeg), a form of pegylated-recombinant-human interleukin-2, against a placebo to see its effect on alopecia areata. It's randomized and double-blind, meaning neither the researchers nor participants know who gets the real treatment or placebo.

How Is the Trial Designed?

Group I: Low Dose Experimental Treatment 1 Intervention

Rezpegaldesleukin Low Dose Every 2 weeks

Group II: High Dose Experimental Treatment 1 Intervention

Rezpegaldesleukin High Dose Every 2 weeks

Group III: Placebo Placebo Group 1 Intervention

Placebo Every 2 weeks

Who Is Running the Clinical Trial?

Nektar Therapeutics

Lead Sponsor

Trials

59

Recruited

9,900+

Howard W. Robin

Nektar Therapeutics

Chief Executive Officer since 2007

B.S. in Accounting and Finance from Fairleigh Dickinson University

Dr. Dimitry Nuyten

Nektar Therapeutics

Chief Medical Officer since 2022

MD

Published Research Related to This Trial

IL-1 receptor antagonist (IL-1Ra) effectively reduces neovascularization in a corneal angiogenesis model, demonstrating a dose-dependent effect, while PEGylated soluble tumor necrosis factor receptor I (PEG sTNFRI) does not show similar efficacy.

In a study involving rats with arthritis, IL-1Ra significantly decreased capillary counts in arthritic paws, indicating that IL-1 inhibitors may provide additional benefits in suppressing angiogenesis compared to anti-TNF agents, despite both treatments reducing inflammation and bone erosion similarly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inhibition of interleukin-1 but not tumor necrosis factor suppresses neovascularization in rat models of corneal angiogenesis and adjuvant arthritis. Coxon, A., Bolon, B., Estrada, J., et al.[2022]

In a study involving adults with moderate-to-severe chronic plaque psoriasis, certolizumab pegol demonstrated significant efficacy, with the 400 mg dose showing the greatest improvement in psoriasis symptoms compared to placebo and being superior to etanercept.

The safety profile of certolizumab was consistent with other anti-tumor necrosis factor drugs, with no new safety concerns identified during the trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Certolizumab pegol for the treatment of chronic plaque psoriasis: Results through 48 weeks of a phase 3, multicenter, randomized, double-blind, etanercept- and placebo-controlled study (CIMPACT). Lebwohl, M., Blauvelt, A., Paul, C., et al.[2018]

In a clinical trial involving 45 participants with severe alopecia areata, alefacept did not show any significant improvement in hair regrowth compared to a placebo after 12 weeks of treatment.

The study concluded that alefacept, which is approved for psoriasis treatment, is ineffective for treating severe alopecia areata, indicating that it may not be a suitable option for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alefacept for severe alopecia areata: a randomized, double-blind, placebo-controlled study. Strober, BE., Menon, K., McMichael, A., et al.[2018]

Alefacept is an effective treatment for plaque psoriasis, showing statistically significant improvements in patients, with more achieving a PASI 75 response compared to placebo after a course of 12 intramuscular injections.

The drug works by inducing the death of activated T cells involved in psoriasis and is well-tolerated, with rare adverse events, making it a promising option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alefacept for the treatment of psoriasis and other dermatologic diseases. Strober, BE., Menon, K.[2018]

The mono-PEGylated recombinant human interleukin-11 (PEG-IL11) demonstrated a significantly longer half-life of 67 hours in cynomolgus monkeys compared to the un-PEGylated version, suggesting it could enhance thrombopoiesis in humans more effectively with less frequent dosing.

Toxicity studies indicated that PEG-IL11 was well tolerated at doses of 0.1-0.3 mg/kg, with only mild to moderate side effects observed, and no additional toxicities from the PEG modification, indicating a promising safety profile for future clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preclinical evaluation of the mono-PEGylated recombinant human interleukin-11 in cynomolgus monkeys. Yu, KM., Lau, JY., Fok, M., et al.[2018]

In phase 3 studies, certolizumab pegol (400 mg and 200 mg) significantly improved symptoms of moderate-to-severe chronic plaque psoriasis compared to placebo, with effects maintained through week 48.

The safety profile of certolizumab was consistent with other treatments in its class, showing no unexpected adverse events, indicating a favorable risk-benefit balance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Certolizumab pegol for the treatment of chronic plaque psoriasis: Results through 48 weeks from 2 phase 3, multicenter, randomized, double-blinded, placebo-controlled studies (CIMPASI-1 and CIMPASI-2). Gottlieb, AB., Blauvelt, A., Thaçi, D., et al.[2018]

In a phase 2/3 trial involving Japanese patients with moderate to severe plaque psoriasis, certolizumab pegol (CZP) demonstrated significant efficacy, with 84.2% to 85.7% of patients achieving a 75% reduction in psoriasis severity (PASI 75) at week 52 when treated with 400 mg Q2W, regardless of body mass index (BMI) or baseline disease severity.

Patients receiving the higher dose of CZP (400 mg Q2W) generally showed better treatment responses compared to those on the lower dose (200 mg Q2W), indicating that higher dosing may lead to more effective long-term management of psoriasis symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Certolizumab Pegol in Japanese Patients with Moderate to Severe Plaque Psoriasis: Effect of Demographics and Baseline Disease Characteristics on Efficacy. Imafuku, S., Tada, Y., Umezawa, Y., et al.[2022]

In a head-to-head trial involving 302 patients over 52 weeks, ixekizumab demonstrated significantly greater efficacy than ustekinumab, with 76.5% of ixekizumab-treated patients achieving a PASI 90 response compared to 59.0% for ustekinumab.

Both treatments had comparable safety profiles, but ixekizumab was associated with a higher incidence of injection site reactions (16.3% vs. 1.2% for ustekinumab), indicating a need for monitoring in patients receiving ixekizumab.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ixekizumab provides superior efficacy compared with ustekinumab over 52 weeks of treatment: Results from IXORA-S, a phase 3 study. Paul, C., Griffiths, CEM., van de Kerkhof, PCM., et al.[2019]

In a real-life study involving 153 patients with psoriasis and psoriatic arthritis, certolizumab significantly reduced disease activity, with mean Psoriasis Area and Severity Index (PASI) scores improving by 4.45, 6.30, and 7.58 at weeks 12, 24, and 52, respectively.

By week 52, 83.3% of patients achieved a PASI score of 3 or lower, indicating substantial improvement, while other measures of joint and pain activity also showed significant reductions, confirming certolizumab's effectiveness and safety in routine clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Certolizumab for the treatment of psoriasis and psoriatic arthritis: a real-world multicentre Italian study. Dattola, A., Balato, A., Megna, M., et al.[2021]

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