~37 spots leftby Aug 2025

Rezpegaldesleukin for Alopecia Areata

Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Nektar Therapeutics
Prior Safety Data

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.
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.35689
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.14568
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.23567
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.

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.

Treatment Details

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.
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Low DoseExperimental Treatment1 Intervention
Rezpegaldesleukin Low Dose Every 2 weeks
Group II: High DoseExperimental Treatment1 Intervention
Rezpegaldesleukin High Dose Every 2 weeks
Group III: PlaceboPlacebo Group1 Intervention
Placebo Every 2 weeks

Find a clinic near you

Research locations nearbySelect from list below to view details:
Indiana Clinical and Translational Sciences Institute (CTSI) Clinical Research CenterIndianapolis, IN
Austin Institute for Clinical ResearchPflugerville, TX
Nektar Investigative SiteNorthridge, CA
Nektar Investigative SiteAtlanta, GA
More Trial Locations
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Who is running the clinical trial?

Nektar TherapeuticsLead Sponsor

References

Inhibition of interleukin-1 but not tumor necrosis factor suppresses neovascularization in rat models of corneal angiogenesis and adjuvant arthritis. [2022]To assess the capacities of the cytokine inhibitors interleukin-1 receptor antagonist (IL-1Ra; anakinra) and PEGylated soluble tumor necrosis factor receptor I (PEG sTNFRI; pegsunercept) to suppress neovascularization.
Alefacept for the treatment of psoriasis and other dermatologic diseases. [2018]Alefacept is a novel biologic agent for the treatment of plaque psoriasis. Alefacept is a fully human recombinant dimeric fusion protein composed of the terminal portion of Leukocyte Functioning Antigen-3 (LFA-3) and the Fc portion of human IgG(1). The drug likely works in part by inducing the apoptosis of memory effector (activated) T cells that play a central role in the pathophysiology of psoriasis. Alefacept also may interrupt the direct immunologic activation of T cells by antigen presenting cells. Alefacept is administered as a course of 12 intramuscular injections, but other dosing strategies have been explored. After a course of therapy, statistically more patients receiving alefacept achieve a psoriasis area and severity index (PASI) 75 response than those receiving a placebo. Some patients who achieve PASI 75 also experience long-term remissions from psoriasis. The drug is well-tolerated and adverse events are rare. Off-label use of the drug is growing and may be formally explored in the future.
Alefacept for severe alopecia areata: a randomized, double-blind, placebo-controlled study. [2018]To assess the efficacy of alefacept for the treatment of severe alopecia areata (AA).
Preclinical evaluation of the mono-PEGylated recombinant human interleukin-11 in cynomolgus monkeys. [2018]The mono-PEGylated recombinant human interleukin-11 (rhIL-11) was evaluated for its pharmacology and toxicology profile in non-human primates. This PEGylated IL-11 (PEG-IL11) showed a much prolonged circulating half-life of 67h in cynomolgus monkeys as compared to its un-PEGylated counterpart (~3h) through subcutaneous administration, implicating that a single injection of the recommended dose will effectively enhance thrombopoiesis in humans for a much longer period of time compared to rhIL-11 in humans (t1/2=6.9h). The toxicokinetics study of single dose and multiple doses showed that systemic exposure was positively correlated with the dosing level, implying that efficacy and toxicity were mechanism-based. A single high dose at 6.25mg/kg through subcutaneous route revealed tolerable and transient toxicity. Multiple-dose in monkeys receiving 0.3mg/kg weekly of the drug developed only mild to moderate toxicity. Major adverse events and immunogenicity in monkeys were only observed in the overdose groups. Bones were positively impacted; while reversible toxicities in heart, liver, kidney and lung observed were likely to be consequences of fluid retention. In summary, the PEG moiety on rhIL-11 did not elicit additional toxicities, and the drug under investigation was found to be well tolerated in monkeys after receiving a single effective dose of 0.1-0.3mg/kg through subcutaneous delivery, which may be allometrically scaled to a future clinical dose at 30-100μg/kg, creating a potential long acting, safer, and more convenient treatment approach based on rhIL-11.
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]Certolizumab pegol, the only Fc-free, PEGylated anti-tumor necrosis factor biologic, demonstrated clinically meaningful improvements suggestive of a positive risk-benefit balance in phase 2 studies in adults with moderate-to-severe chronic plaque psoriasis.
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]Phase 2 psoriasis studies with the Fc-free, PEGylated, anti-tumor necrosis factor biologic certolizumab pegol demonstrated meaningful clinical activity.
Ixekizumab provides superior efficacy compared with ustekinumab over 52 weeks of treatment: Results from IXORA-S, a phase 3 study. [2019]Biologics targeting interleukin 17A (IL-17A) allow for rapid clearance of psoriatic plaques, with a clinically favorable safety profile.
Certolizumab for the treatment of psoriasis and psoriatic arthritis: a real-world multicentre Italian study. [2021]Certolizumab, a pegylated tumour necrosis factor-α inhibitor, reduced disease activity in randomized trials of patients with psoriasis and psoriatic arthritis. Real-life data are missing.
Certolizumab Pegol in Japanese Patients with Moderate to Severe Plaque Psoriasis: Effect of Demographics and Baseline Disease Characteristics on Efficacy. [2022]We present certolizumab pegol (CZP) efficacy data across patient demographic and baseline disease characteristic subgroups from a phase 2/3 trial investigating CZP treatment in Japanese patients with moderate to severe plaque psoriasis (PSO; ClinicalTrials.gov identifier: NCT03051217).