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MEDI3506

Phase 2

Asthma | Monoclonal antibody | Respiratory |AstraZeneca PLC|Last Updated: Jul 10, 2024

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment250

FDA Designations

No designations recorded

Clinical trial landscape

MEDI3506 · 5 trials · 7 indications

Phase 2 3Phase 1 2
NCT04570657Study to Assess the Efficacy and Safety of MEDI3506 in Adults With Uncontrolled Moderate-to-severe AsthmaAsthma
COMPLETED250 Analytics
NCT04212169Efficacy and Safety of MEDI3506 in Adult Subjects With Atopic DermatitisAtopic Dermatitis
COMPLETED148 Analytics
NCT04170543A Phase 2b Diabetic Kidney Disease StudyDiabetic Kidney Disease
COMPLETED609 Analytics
PHASE2COMPLETED
Study to Assess the Efficacy and Safety of MEDI3506 in Adults With Uncontrolled Moderate-to-severe Asthma
AsthmaUnlock trial analytics
PHASE2COMPLETED
Efficacy and Safety of MEDI3506 in Adult Subjects With Atopic Dermatitis
Atopic DermatitisUnlock trial analytics
PHASE2COMPLETED
A Phase 2b Diabetic Kidney Disease Study
Diabetic Kidney DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

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
Baseline and week 16

In-clinic spirometry measurements were taken prior to the administration of bronchodilators. Baseline was the last measurement prior to first injection of investigational product (IP). The least squares (LS) means, LS mean differences and 80% confidence intervals (CIs), and one-sided p-value results were based on a mixed model repeated measures (MMRM). The model included fixed effects for baseline, background medication, geographic region, baseline inhaled corticosteroids (ICS) total daily dose, visit, treatment, and the baseline by visit and treatment by visit interactions. Visits within participant were considered as repeated measurements.

Percent Change From Baseline to Week 16 in EASI Score
Week 16

The EASI evaluates 4 anatomic regions for severity and extent of key disease signs and focuses on the acute and chronic signs of inflammation (ie, erythema, edema, papulation, excoriation, and lichenification). The maximum score is 72, with higher values indicating more severe disease. Analysis was performed using mixed effect model for repeated measures and MCP-mod dose response model.

Percent Change From Baseline to Day 169 (Week 24) in UACR - Per Protocol Population
From baseline to Day 169

UACR values are collected as triplicates at baseline and at each CSP planned visit. For each triplicate, the UACR are averaged with geometric mean. Baseline is defined as the geometric mean of UACR measurements prior to first dose of study treatment. For the intercurrent events, if a subject is lost to follow-up (EOT), discontinues treatment due to AE, or uses prohibited medication, the UACR data are treated as missing on or after the event and no imputation is performed. The LS means of percent change and difference in percent change, corresponding 90% confidence intervals are calculated based on a mixed model with repeated measures (MMRM) of log (UACR post-baseline/UACR baseline) as the response, adjusting for fixed effects of treatment, visit, and treatment-by-visit interaction, SGLT2i, region (Japan or ROW), baseline log UACR, and baseline log UACR-by-visit interaction. The MMRM includes UACR values at protocol specified visits from baseline up to Day 169.

Maximum observed concentration (Cmax)
Day 1 to Day 113

To assess the maximum plasma concentration of MEDI3506 after single subcutaneous administrations in healthy Chinese participants.

Area under the serum concentration time curve to the infinite (AUC0-inf)
Day 1 to Day 113

To assess the area under the serum concentration time curve from pre-dose until infinite after single Subcutaneous administration of MEDI3506 in healthy Chinese participants

Area under the serum concentration time curve to the last observation(AUC0-t)
Day 1 to Day 113

To assess the area under the serum concentration time curve from pre-dose until the last observation quantified after single Subcutaneous administration of MEDI3506 in healthy Chinese participants

Terminal Elimination half-life (t1/2)
Day 1 to Day 113

To assess the terminal elimination half-life after single Subcutaneous administration of MEDI3506 in healthy Chinese participants

Apparent total body Clearance (CL/F)
Day 1 to Day 113

To evaluate the apparent MEDI3506 total body clearance from serum after single subcutaneous administration of MEDI3506 in healthy Chinese participants

Apparent volume of distribution based on terminal phase (Vz/F)
Day 1 to Day 113

To assess the apparent volume of distribution of MEDI3506 after single subcutaneous administration of MEDI3506 in healthy Chinese participants

Time to reach maximum observed concentration (tmax)
Day 1 to Day 113

To assess the MEDI3506 time to reach peak serum concentration after single subcutaneous administration of MEDI3506 in healthy Chinese participants.

Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and Treatment-emergent Adverse Events of Special Interest (TEAESI) in Part 1, Part 2, and Part 3
From Day 1 through Day 169

An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. An adverse event of special interest (AESI) was defined as any serious or nonserious event of scientific and medical interest specific to understand the study drug.

Number of Participants With Grade 2 or More Toxicity Grades Reported in Laboratory Parameters at Day 169 for Part 1, Part 2, and Part 3
Day 169

Number of participants with Grade 2 or more toxicity grades reported in laboratory parameters are reported. Abnormal clinical laboratory parameters defined as any abnormal finding during analysis of hematology and serum chemistry.

Changes From Baseline in Blood Pressure at Day 169 in Part 1, Part 2, and Part 3
Day 169

Change from baseline in blood pressure at Day 169 in Part 1, Part 2, and Part 3 are reported.

Changes From Baseline in Pulse Rate at Day 169 in Part 1, Part 2, and Part 3
Baseline (Day 1) and Day 169

Change from baseline in pulse rate at Day 169 in Part 1, Part 2, and Part 3 is reported.

Changes From Baseline in Respiratory Rate at Day 169 in Part 1, Part 2, and Part 3
Baseline (Day 1) and Day 169

Change from baseline in respiratory rate at Day 169 in Part 1, Part 2, and Part 3 are reported.

Changes From Baseline in Body Temperature Rate at Day 169 in Part 1, Part 2, and Part 3
Baseline (Day 1) and Day 169

Change from baseline in body temperature at Day 169 in Part 1, Part 2, and Part 3 are reported.

Number of Participants With Change From Baseline in QTcF in Part 1, Part 2, and Part 3
Baseline (Day 1) and Day 169

Number of participants with change from basleine in QTcF in Part 1, Part 2, and Part 3 are reported. The change from baseline in QTcF at Day 169 data are reported in 3 categories as: \<= 30 msec, \> 30 to \<= 60 msec, and \> 60 msec.

Secondary Endpoints

Change From Baseline to Weeks 8 and 16 in Post-bronchodilator (Post-BD) FEV1 as Measured in the Study Clinic
Baseline and weeks 8 and 16
Serum Concentrations of Tozorakimab
Pharmacokinetic (PK) samples were taken pre-dose (day 1) and at weeks 1, 4, 8, 12, 16, 20, and 24
Number of Participants With Anti-drug Antibodies (ADAs)
Blood samples were taken pre-dose (day 1) and at weeks 1, 4, 8, 12, 16, and 24
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MEDI3506 Dose 1EXPERIMENTALApproximately 76 participants will be randomized to this arm to receive the higher dose of MEDI3506
MEDI3506 Dose 2EXPERIMENTALApproximately 76 participants will be randomized to this arm to receive the lower dose of MEDI3506
PlaceboPLACEBO_COMPARATORApproximately 76 participants will be randomized to this arm. Participants in this group will receive the placebo.
MEDI3506 at dose level 1EXPERIMENTALParticipant will receive multiple doses of MEDI3506 at dose level 1.
MEDI3506 at dose level 2EXPERIMENTALParticipant will receive multiple doses of MEDI3506 at dose level 2.
MEDI3506 at dose level 3EXPERIMENTALParticipant will receive multiple doses of MEDI3506 at dose level 3.
Group 1EXPERIMENTALMEDI3506 Dose 1 plus Dapagliflozin (Day 85 to Day 168).
Group 2EXPERIMENTALMEDI3506 Dose 2 plus Dapagliflozin (Day 85 to Day 168).
Group 3EXPERIMENTALMEDI3506 Dose 3 plus Dapagliflozin (Day 85 to Day 168).
Group 4EXPERIMENTALMEDI3506 Dose 4 plus Dapagliflozin (Day 85 to Day 168).
Group 5PLACEBO_COMPARATORPlacebo (volume matched) plus Dapagliflozin (Day 85 to Day 168).
Part 1: PlaceboPLACEBO_COMPARATORHealthy participants with a history of mild atopy and proven sensitivity to house dust mite (HDM) will receive a single dose of placebo matched to MEDI3506 subcutaneously or intravenously.
Part 1: MEDI3506 SC Dose 1EXPERIMENTALHealthy participants with a history of mild atopy and proven sensitivity to HDM will receive a single MEDI3506 Dose 1 subcutaneously.
Part 1: MEDI3506 SC Dose 2EXPERIMENTALHealthy participants with a history of mild atopy and proven sensitivity to HDM will receive a single MEDI3506 Dose 2 subcutaneously.
Part 1: MEDI3506 SC Dose 3EXPERIMENTALHealthy participants with a history of mild atopy and proven sensitivity to HDM will receive a single MEDI3506 Dose 3 subcutaneously.
Part 1: MEDI3506 SC Dose 4EXPERIMENTALHealthy participants with a history of mild atopy and proven sensitivity to HDM will receive a single MEDI3506 Dose 4 subcutaneously.
Part 1: MEDI3506 SC Dose 5EXPERIMENTALHealthy participants with a history of mild atopy and proven sensitivity to HDM will receive a single MEDI3506 Dose 5 subcutaneously.
Part 1: MEDI3506 SC Dose 6EXPERIMENTALHealthy participants with a history of mild atopy and proven sensitivity to HDM will receive a single MEDI3506 Dose 6 subcutaneously.
Part 1: MEDI3506 IV Dose 6EXPERIMENTALHealthy participants with a history of mild atopy and proven sensitivity to HDM will receive a single MEDI3506 Dose 6 intravenously.
Part 2: PlaceboPLACEBO_COMPARATORParticipants with COPD will receive 3 administration of placebo matched to MEDI3506 subcutaneously two weeks apart over a 4-week dosing period (doses on Days 1, 15, and 29).
Part 2: MEDI3506 SC Dose 4EXPERIMENTALParticipants with COPD will receive 3 administration of MEDI3506 Dose 4 subcutaneously two weeks apart over a 4-week dosing period (doses on Days 1, 15, and 29).
Part 2: MEDI3506 SC Dose 5EXPERIMENTALParticipants with COPD will receive 3 administration of MEDI3506 Dose 5 subcutaneously two weeks apart over a 4-week dosing period (doses on Days 1, 15, and 29).
Part 2: MEDI3506 SC Dose 6EXPERIMENTALParticipants with COPD will receive 3 administration of MEDI3506 Dose 6 subcutaneously two weeks apart over a 4-week dosing period (doses on Days 1, 15, and 29).
Part 3: PlaceboPLACEBO_COMPARATORHealthy Japanese participants will receive a single dose of placebo matched to MEDI3506 intravenously.
Part 3: MEDI3506 IV Dose 6EXPERIMENTALHealthy Japanese participants will receive a single MEDI3506 Dose 6 intravenously.

Interventions

NameTypeDescription
MEDI3506BIOLOGICALParticipants will receive multiple doses of MEDI3506 at dose level 1 or dose level 2
PlaceboDRUGParticipants will receive multiple doses of placebo
DapagliflozinDRUGDapagliflozin 10 mg
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites65

INCLUSION CRITERIA * Aged 18 to \< 65 years of age * Physician-diagnosed asthma of early onset, defined as development of asthma before the age of 25 years. * History of ≥ 1 asthma exacerbation in previous 24 months * Treated with medium to high dose ICS defined as total daily dose of \> 250 g flut...

Countries:United StatesArgentinaGermanyHungaryPolandSouth AfricaUnited KingdomAustraliaSpainCanadaChileJapanPeruSouth KoreaChina
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Frequently asked questions about MEDI3506

What is MEDI3506 used for?

MEDI3506 is an investigational monoclonal antibody being studied for atopic dermatitis, diabetic kidney disease, asthma, and chronic obstructive pulmonary disease. It has also been evaluated in healthy volunteers. The drug is being developed by AstraZeneca PLC (AZN) and is currently in Phase 2 clinical development.

What does MEDI3506 target?

MEDI3506 is a monoclonal antibody, but its specific molecular target has not been disclosed in available clinical trial information. The drug is being investigated for its potential effects in inflammatory and respiratory conditions, including atopic dermatitis and asthma.

Who makes MEDI3506?

MEDI3506 is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the NASDAQ under the ticker symbol AZN. AstraZeneca is conducting clinical trials to evaluate the safety and efficacy of MEDI3506 across multiple indications.

What phase is MEDI3506 in?

MEDI3506 is currently in Phase 2 clinical development. It has completed Phase 1 trials in healthy participants and patients with chronic obstructive pulmonary disease, as well as Phase 2 trials in diabetic kidney disease and atopic dermatitis. The drug is not yet approved by regulatory authorities.

What clinical trials is MEDI3506 in?

MEDI3506 has been studied in several completed clinical trials, including NCT03096795 (Phase 1 in healthy participants and COPD patients), NCT04170543 (Phase 2b in diabetic kidney disease), NCT04212169 (Phase 2 in atopic dermatitis), and NCT05070312 (Phase 1 in healthy Chinese participants).

Is MEDI3506 the same as other drugs?

MEDI3506 is a distinct investigational drug developed by AstraZeneca. No alternative names for MEDI3506 have been reported in clinical trial registrations. It is being studied as a potential treatment for conditions such as atopic dermatitis and diabetic kidney disease.