Depemokimab for Asthma

No longer recruiting at 2 trial locations
UG
EG
Overseen ByEU GSK Clinical Trials Call Center
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: GlaxoSmithKline
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new asthma treatment called Depemokimab. Researchers aim to observe how the body absorbs and reacts to the drug when administered through either a special device or an autoinjector. The trial seeks generally healthy participants with no major health issues or drug allergies. Those who are healthy and interested in the development of new treatments may find this opportunity suitable. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have any health conditions or are taking medications that could affect the study, you might not be eligible to participate.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that depemokimab is generally safe for humans. In earlier studies with healthy adults, depemokimab proved about 29 times more effective than similar treatments and remained in the body longer, often indicating safety. Another study involving individuals with asthma or chronic sinus issues with nasal polyps found it safe when administered twice a year. Although these results are preliminary, they suggest depemokimab is safe for humans thus far. Prospective participants should consult a healthcare professional before joining a trial.12345

Why are researchers excited about this trial?

Unlike the standard asthma treatments, which often include inhaled corticosteroids and bronchodilators, depemokimab is unique because it is administered via a single subcutaneous dose (SSD) or an autoinjector, offering convenience and potential for better adherence. Researchers are excited about depemokimab because it targets a different pathway in the immune system, potentially leading to more effective control of asthma symptoms. This novel approach could provide relief for patients who don't respond well to conventional therapies.

What evidence suggests that Depemokimab might be an effective treatment for asthma?

Research has shown that Depemokimab can significantly benefit individuals with severe asthma, particularly those with elevated eosinophils, a specific type of white blood cell. Studies have found that Depemokimab can reduce severe asthma attacks by 54%. This treatment targets a protein called IL-5, which contributes to inflammation. In this trial, participants will receive Depemokimab either via an SSD or an autoinjector. As a long-lasting medication, Depemokimab remains in the body longer, enhancing its effectiveness in alleviating asthma symptoms. Its potency and extended presence in the body make it a promising option for asthma relief.36789

Who Is on the Research Team?

GC

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Are You a Good Fit for This Trial?

Healthy adults who weigh at least 50 kg with a BMI of 19-30 can join. They must have no significant allergies, especially to monoclonal antibodies or biologics, and no history of severe drug allergies or substance abuse. Women able to get pregnant should use effective birth control.

Inclusion Criteria

Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, clinical laboratory tests, vital sign measurements, and 12-lead electrocardiogram results.
Body weight greater than or equal to (>=) 50 kilograms (kg) (110 pounds-mass/Ibs) and body mass index within the range 19 to 30 kg per meter square (inclusive).
Capable of giving signed informed consent.
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Exclusion Criteria

You have had serious allergies or intolerances to certain medications or biological treatments in the past.
A positive pre-study drug/alcohol screen or a history (or suspected history) of alcohol misuse or substance abuse.
Clinically significant abnormalities.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of Depemokimab via either a safety syringe device or an autoinjector

1 day

Follow-up

Participants are monitored for safety, tolerability, and immunogenicity after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Depemokimab
Trial Overview The trial is testing Depemokimab delivered through two different devices: a Safety Syringe Device (SSD) and an autoinjector. It aims to compare how the body absorbs the drug, its safety, tolerability, and potential for immune response.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Participants receiving depemokimab via an autoinjectorExperimental Treatment1 Intervention
Group II: Participants receiving depemokimab via a SSDExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials
4,834
Recruited
8,389,000+
Headquarters
London, UK
Known For
Vaccines & Medicines
Top Products
**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)
Dame Emma Walmsley profile image

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron profile image

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

PPD DEVELOPMENT, LP

Industry Sponsor

Trials
167
Recruited
38,000+
David Simmons profile image

David Simmons

PPD DEVELOPMENT, LP

Chief Executive Officer since 2012

BSc in Applied Science from Georgia Institute of Technology

Martina Flammer profile image

Martina Flammer

PPD DEVELOPMENT, LP

Chief Medical Officer since 2024

MD

PPD Development, LP

Industry Sponsor

PPD

Industry Sponsor

Trials
162
Recruited
36,600+
Dr. Austin Smith profile image

Dr. Austin Smith

PPD

Chief Medical Officer since 2020

Doctor of Medicine from the Royal College of Surgeons in Ireland

David Simmons profile image

David Simmons

PPD

Chief Executive Officer since 2012

Bachelor’s degree in Applied Mathematics and Industrial Management from Carnegie Mellon University

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/39248309/
Twice-Yearly Depemokimab in Severe Asthma with an ...Conclusions: Depemokimab reduced the annualized rate of exacerbations among patients with severe asthma with an eosinophilic phenotype.
Depemokimab late-breaking data presented at ERS show ...... data show depemokimab delivered ... Depemokimab late-breaking data presented at ERS show a 54% reduction in severe asthma exacerbations.
Study Results | Placebo-controlled Efficacy and Safety ...A type of eligibility criteria that indicates whether people who do not have the condition/disease being studied can participate in that clinical study. ... An ...
Pharmacokinetics of Depemokimab Delivered by Safety ...Depemokimab is an ultra-long-acting biologic targeting human IL-5, showing approximately 29–fold increased potency and about a 2-fold reduction in clearance ...
GSK announces positive results from phase III severe ...Primary endpoints met in SWIFT-1 and SWIFT-2 trials with statistically significant reduction in exacerbations over 52 weeks vs. placebo.
Pharmacokinetics of Depemokimab Delivered by Safety ...Depemokimab is an ultra‐long‐acting biologic targeting human IL‐5, showing approximately 29‐fold increased potency and about a 2‐fold reduction in clearance ...
Pharmacokinetics of Depemokimab Delivered by Safety ...Healthy adult participants were randomized I:I to SSD or AI treatment arms and I:I:I to the injection site (upper arm, abdomen, or thigh).
Depemokimab Completed Phase 1 Trials for Asthma ...A Study to Compare the Pharmacokinetics (PK) of Depemokimab When Delivered With a Safety Syringe Device (SSD) or an Autoinjector in Healthy Adult Participants.
Pharmacokinetics of Depemokimab Delivered by Safety ...This Phase I, randomized, multicenter, open-label, parallel-group, single-dose study assessed the relative bioavailability of the anti–interleukin-5 antibody ...
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