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Monoclonal Antibodies

MEDI3506 for Asthma (FRONTIER-3 Trial)

Phase 2
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pharmacokinetic (pk) samples were taken pre-dose (day 1) and at weeks 1, 4, 8, 12, 16, 20, and 24
Awards & highlights

FRONTIER-3 Trial Summary

This trial is a Phase II, double-blind, placebo-controlled study to evaluate the efficacy of MEDI3506 in adults with uncontrolled moderate to severe asthma. Up to 80 sites will enroll a total of 228 participants who will be randomly assigned to receive either MEDI3506 dose 1, MEDI3506 dose 2, or placebo. The primary outcome measure will be the change from baseline in percent-predicted forced expiratory volume in 1 second (ppFEV1) at Week 12.

FRONTIER-3 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pharmacokinetic (pk) samples were taken pre-dose (day 1) and at weeks 1, 4, 8, 12, 16, 20, and 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and pharmacokinetic (pk) samples were taken pre-dose (day 1) and at weeks 1, 4, 8, 12, 16, 20, and 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline to Week 16 in Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in the First Second (FEV1) as Measured in the Study Clinic
Secondary outcome measures
Asthma CompEx Annualised Event Rate
Change From Baseline to Week 16 in St George's Respiratory Questionnaire (SGRQ) Domain and Total Scores
Change From Baseline to Week 16 in the Asthma Control Questionnaire-6 (ACQ-6) Score
+8 more
Other outcome measures
Change From Baseline to Week 16 in Pre-BD FEV1 as Measured in the Study Clinic: Analysis Per Number of Exacerbations in Last 12 Months
Eosinophil Count

Side effects data

From 2022 Phase 2 trial • 148 Patients • NCT04212169
11%
Eczema
11%
Nasopharyngitis
11%
Pain in extremity
11%
Pruritus
6%
Abdominal discomfort
6%
Oral herpes
6%
Dyspnoea
6%
Dry mouth
6%
Palpitations
6%
Injection site reaction
6%
Otitis externa
6%
Diarrhoea
6%
Covid-19 pneumonia
6%
Venous thrombosis limb
6%
Fall
6%
Bronchitis
6%
Arthropod bite
6%
Conjunctivitis
6%
Urinary tract infection
6%
Eczema infected
6%
Gastroenteritis viral
6%
Myalgia
6%
Insomnia
6%
Injection site bruising
6%
Influenza
6%
Cellulitis
6%
Injection site swelling
6%
Oropharyngeal pain
6%
Influenza like illness
100%
80%
60%
40%
20%
0%
Study treatment Arm
MEDI3506 Dose 2
MEDI3506 Dose 1
MEDI3506 Dose 3
Placebo

FRONTIER-3 Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: MEDI3506 Dose 2Experimental Treatment1 Intervention
Approximately 76 participants will be randomized to this arm to receive the lower dose of MEDI3506
Group II: MEDI3506 Dose 1Experimental Treatment1 Intervention
Approximately 76 participants will be randomized to this arm to receive the higher dose of MEDI3506
Group III: PlaceboPlacebo Group1 Intervention
Approximately 76 participants will be randomized to this arm. Participants in this group will receive the placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MEDI3506
2021
Completed Phase 2
~1270

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,265 Previous Clinical Trials
288,605,032 Total Patients Enrolled
328 Trials studying Asthma
639,384 Patients Enrolled for Asthma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies left for individuals to partake in this research?

"Reports on clinicaltrials.gov demonstrate that this medical trial is no longer looking for participants, as the last update was made on November 25th 2022. Although recruitment has finished, there are still 319 other studies recruiting individuals at this time."

Answered by AI

To whom is access to this trial available?

"Candidates hoping to partake in this trial must be aged 18 and 65, with a primary diagnosis of asthma. Upwards of 250 participants are being sought by the research team."

Answered by AI

How much geographical coverage does this research encompass in the city?

"At present, potential participants can register at twelve different medical sites. These locations include Medford, Missoula and Ames, along with nine other locales. It is advisable to enroll your nearest centre in order to minimize travel requirements."

Answered by AI

Are individuals younger than 25 years allowed to partake in the experiment?

"The requirements for this trial signifies individuals between 18 and 65 years old can be potentially enrolled. There are 113 trials open to minors, and 198 studies available for seniors."

Answered by AI

To what extent could MEDI3506 pose a threat to human health?

"MEDI3506's safety was assessed to be a 2, as the Phase 2 trial has only provided limited data on its security but no evidence of efficacy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study to Assess the Efficacy and Safety of MEDI3506 in Adults With Uncontrolled Moderate-to-severe Asthma
2020. "Study to Assess the Efficacy and Safety of MEDI3506 in Adults With Uncontrolled Moderate-to-severe Asthma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04570657.
~55 spots leftby Apr 2025
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