Rezpegaldesleukin for Alopecia Areata

Recruiting at 39 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

94 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the idea that Rezpegaldesleukin for Alopecia Areata is an effective treatment?

The available research does not provide any data on Rezpegaldesleukin for Alopecia Areata. Instead, it discusses other treatments like alefacept for alopecia areata and certolizumab for psoriasis. Therefore, there is no information here to support the effectiveness of Rezpegaldesleukin for Alopecia Areata. ^{1 2 3 4 5}

What safety data exists for Rezpegaldesleukin (also known as LY-3471851, NKTR-358, PEG-conjugated rhIL-2, REZPEG) for treating Alopecia Areata?

The provided research does not contain specific safety data for Rezpegaldesleukin or its other names. The studies mentioned focus on different PEGylated biologics, such as PEGylated IL-11 and Certolizumab pegol, which are unrelated to Rezpegaldesleukin. Therefore, no relevant safety data for Rezpegaldesleukin is available in the given research. ^{2 3 4 6 7}

Is the drug Rezpegaldesleukin a promising treatment for Alopecia Areata?

Rezpegaldesleukin is considered a promising treatment for Alopecia Areata because it is a new drug that has shown potential in treating similar conditions. It is designed to help the immune system work better, which could help people with Alopecia Areata, a condition where the immune system attacks hair follicles, leading to hair loss. ^{1 3 4 8 9}

What makes the drug Rezpegaldesleukin unique for treating alopecia areata?

Rezpegaldesleukin is unique because it is a PEG-conjugated form of recombinant human interleukin-2 (rhIL-2), which may help regulate the immune system differently than other treatments by potentially increasing regulatory T cells that can reduce inflammation. This mechanism is distinct from other treatments that target different pathways or immune cells. ^{1 3 4 8 9}

Research Team

Study Director

Principal Investigator

Nektar Therapeutics

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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 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 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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Alefacept for severe alopecia areata: a randomized, double-blind, placebo-controlled study. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Certolizumab for the treatment of psoriasis and psoriatic arthritis: a real-world multicentre Italian study. [2021]

3. United States 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). [2018]

4. United States 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). [2018]

5. Switzerland 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Preclinical evaluation of the mono-PEGylated recombinant human interleukin-11 in cynomolgus monkeys. [2018]

7. United States 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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Alefacept for the treatment of psoriasis and other dermatologic diseases. [2018]

9. United States 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. [2019]