Phase 2
Completed N=235
Study to Assess the Efficacy and Safety of MEDI3506 in Adults With Uncontrolled Moderate-to-severe Asthma
Source: ClinicalTrials.gov NCT04570657 ↗Enrolled (actual)
235
Serious AEs
3.0%
Results posted
Jan 2024
Primary outcomePrimary: 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 — 0.148; 0.116; 0.112 litres — p=0.267
Summary
Study D9181C00001 is a Phase II, randomised, double-blind, placebo-controlled, parallel group, proof of concept study to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of MEDI3506 in adult participants with uncontrolled moderate to severe asthma on standard of care (SOC). Up to approximately 80 sites globally will participate in this study.
Approximately 228 participants will be randomized to 3 treatment groups in a 1:1:1 ratio to receive MEDI3506 dose 1, MEDI3506 dose 2, or placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
0.148; 0.116; 0.112 | 0.267 |
| SECONDARY Change From Baseline to Weeks 8 and 16 in Post-bronchodilator (Post-BD) FEV1 as Measured in the Study Clinic |
-0.062; 0.008; -0.050; -0.064; -0.050; -0.026 | 0.437 |
| SECONDARY Serum Concentrations of Tozorakimab |
NA; NA; 8939.24; 18374.15; 2165.82; 4102.04 | — |
| SECONDARY Number of Participants With Anti-drug Antibodies (ADAs) |
3; 3; 1; 3; 2; 1 | — |
| SECONDARY Change From Baseline to Week 16 in the Asthma Control Questionnaire-6 (ACQ-6) Score |
-0.925; -0.942; -0.895 | 0.416 |
| SECONDARY Number of Participants With a Decrease in ACQ-6 Score ≥ 0.5 From Baseline to Week 16 |
53; 56; 53 | 0.612 |
| SECONDARY Number of Participants Achieving ACQ-6 Well Controlled Status at Week 16 |
17; 18; 21 | 0.575 |
| SECONDARY Change From Baseline to Week 16 in St George's Respiratory Questionnaire (SGRQ) Domain and Total Scores |
-10.340; -11.706; -10.342; -8.237; -8.509; -6.816 | 0.500 |
| SECONDARY Number of Participants With a Decrease in SGRQ Total Score of ≥ 4 Points From Baseline to Week 16 |
50; 53; 54 | 0.828 |
| SECONDARY Number of Participants With at Least One Asthma CompEx Event From Baseline to Week 16 |
19; 15; 15 | 0.239 |
| SECONDARY Asthma CompEx Annualised Event Rate |
0.86; 0.69; 0.99 | 0.346 |
| SECONDARY Percent Change From Baseline to Week 16 in Concentration of Fractional Exhaled Nitric Oxide (FeNO) in Exhaled Breath |
-17.429; -16.500; -5.007 | 0.029 sig |
Eligibility Criteria
INCLUSION CRITERIA
- Aged 18 to 250 g fluticasone dry powder or equivalent, for at least 12 months and on a stable dose for ≥ 3 months.
- Stable LABA therapy for ≥ 3 months.
- An ACQ-6 score ≥ 1.5.
- Morning pre-BD FEV1 ≥ 40% predicted normal and > 1 L.
- Morning pre-BD FEV1 10 pack years.
- As judged by the investigator, any evidence of any active medical or psychiatric condition or other reason (prior to randomisation) that in the investigator's opinion makes it undesirable for the participant to participate in the study.
- Any clinically important pulmonary disease other than asthma.
- Any other clinically relevant abnormal findings on physical examination or laboratory testing, that in the opinion of the investigator or medical monitor might compromise the safety of the participant in the study or interfere with evaluation of the study intervention.
- A known history of severe reaction to any medication including biologic agents or human gamma globulin therapy.
- History of, or a reason to believe, a participant has a history of, drug or alcohol abuse within the past 2 years.
- Current diagnosis of cancer.
- History of cancer, except if treated with apparent success with curative therapy (response duration of > 5 years).
- History of allogeneic bone marrow transplant.
- A helminth parasitic infection diagnosed within 6 months prior to SV4 (randomisation) that has not been treated, or has not responded to SOC therapy.
- An asthma exacerbation within 8 weeks.
- Receiving any prohibited concomitant medications or therapies as specified in the protocol:
Known history of allergy or reaction to any component of the study intervention formulation, including hereditary fructose intolerance.
Data sourced from ClinicalTrials.gov (NCT04570657). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.