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Monoclonal Antibodies

Study to Assess the Efficacy and Safety of MEDI3506 in Adults With Uncontrolled Moderate-to-severe 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

Summary

This trial is testing a new medication called MEDI3506 to help adults with moderate to severe asthma that isn't well-controlled by their current treatments. The study will compare two different doses of MEDI3506. The goal is to see if MEDI3506 can better manage asthma symptoms by targeting specific pathways in the body.

Eligible Conditions
  • Asthma

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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 study objectives
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 2023 Phase 2 trial • 609 Patients • NCT04170543
6%
Hyperkalaemia
4%
Diarrhoea
4%
Urinary tract infection
3%
Covid-19
3%
Peripheral swelling
2%
Abdominal pain upper
2%
Constipation
2%
Pruritus
2%
Muscle spasms
2%
Nasopharyngitis
2%
Back pain
1%
Cholecystitis acute
1%
Joint effusion
1%
Pain in extremity
1%
Diverticulum intestinal
1%
Vomiting
1%
Pneumonia aspiration
1%
Renal impairment
1%
Musculoskeletal chest pain
1%
Orthopnoea
1%
Injection site inflammation
1%
Infected dermal cyst
1%
Asthenia
1%
Troponin increased
1%
Hypertension
1%
Bile duct stone
1%
Intervertebral disc degeneration
1%
Fungal skin infection
1%
Bleeding varicose vein
1%
Colitis microscopic
1%
C-reactive protein increased
1%
Dyspnoea
1%
Oedema peripheral
1%
Hypokalaemia
1%
Gastritis erosive
1%
Toothache
1%
Pharyngitis
1%
Cellulitis
1%
Cardio-respiratory arrest
1%
Metabolic acidosis
1%
Hypovolaemia
1%
Foot deformity
1%
Faecaloma
1%
Vaccination complication
1%
Brain natriuretic peptide increased
1%
Weight increased
1%
Vitamin d deficiency
1%
Restless legs syndrome
1%
Acute kidney injury
1%
Coronary artery disease
1%
Decreased appetite
1%
Sleep apnoea syndrome
1%
Drug hypersensitivity
1%
Cardiac failure
1%
Type 2 diabetes mellitus
1%
Gastric polyps
1%
Septic shock
1%
Hypervolaemia
1%
Pancreatitis
1%
Head injury
1%
Hypothyroidism
1%
Cataract
1%
Hypernatraemia
1%
Muscle fatigue
1%
Fall
1%
Abdominal pain
1%
Blood glucose increased
1%
Gastrooesophageal reflux disease
1%
Spinal stenosis
1%
Rash macular
1%
Folliculitis
1%
Dry skin
100%
80%
60%
40%
20%
0%
Study treatment Arm
MEDI3506 60 mg
MEDI3506 300 mg
MEDI3506 120 mg
MEDI3506 30 mg
Placebo

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
4,411 Previous Clinical Trials
289,123,343 Total Patients Enrolled
348 Trials studying Asthma
656,495 Patients Enrolled for Asthma
~48 spots leftby Dec 2025