Study to Evaluate the Efficacy and Safety of MEDI9929 (AMG 157) in Adult Subjects With Inadequately Controlled, Severe Asthma
NCT ID: NCT02054130
Last Updated: 2018-12-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
584 participants
INTERVENTIONAL
2013-12-13
2017-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
Placebo
Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
MEDI9929 70 mg
Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50.
MEDI9929 70 mg
Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50.
MEDI9929 210 mg
Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50.
MEDI9929 210 mg
Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50.
MEDI9929 280 mg
Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
MEDI9929 280 mg
Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
Interventions
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Placebo
Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
MEDI9929 70 mg
Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50.
MEDI9929 210 mg
Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50.
MEDI9929 280 mg
Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) between 18-40 kg/m2 and weight greater than or equal 40 kg
* Documented physician-diagnosed asthma - Subjects must have received a physician-prescribed asthma controller regimen with medium- or high-dose inhaled corticosteroids (ICS) plus long acting β2 agonist (LABA) -If on asthma controller medications in addition to ICS plus LABA, the dose of the other asthma controller medications (leukotriene receptor inhibitors, theophylline, secondary ICS, long-acting anti-muscarinics (LAMA), cromones, or maintenance oral prednisone or equivalent up to a maximum of 10 mg daily or 20 mg every other day for the maintenance treatment of asthma) must be stable. -Subjects must have a documented history of at least 2 asthma exacerbation events OR at least 1 severe asthma exacerbation resulting in hospitalization within the 12 months prior to first study visit.
Exclusion Criteria
* Current smokers or subjects with a smoking history of ≥ 10 pack years
* Former smokers with \< 10 pack years must have stopped for at least 1 year to be eligible.
* Any concomitant respiratory disease that in the opinion of the investigator and/or medical monitor will interfere with the evaluation of the investigational product or interpretation of subject safety or study results (eg, chronic obstructive pulmonary disease, cystic fibrosis, pulmonary fibrosis, bronchiectasis, allergic bronchopulmonary aspergillosis, Churg-Strauss syndrome).
* Evidence of active liver disease.
* History of Cancer, except for basal cell carcinoma or insitu carcinoma of the cervix treated with apparent success with curative therapy or other malignancies are eligible provided that curative therapy was completed -Known history of active tuberculosis (TB)
* History of anaphylaxis to any biologic therapy
* Positive medical history for hepatitis B or C
* Subject with human immunodeficiency virus (HIV) or subject taking antiretroviral medications, as determined by medical history and/or subject's verbal report.
18 Years
75 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
MedImmune LLC
INDUSTRY
Responsible Party
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Principal Investigators
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MedImmune LLC
Role: STUDY_DIRECTOR
MedImmune LLC
Locations
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Research Site
Los Angeles, California, United States
Research Site
Los Angeles, California, United States
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Miami, Florida, United States
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Oviedo, Florida, United States
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Savannah, Georgia, United States
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Peoria, Illinois, United States
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Baltimore, Maryland, United States
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Rochester, Minnesota, United States
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New York, New York, United States
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New York, New York, United States
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Charlotte, North Carolina, United States
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Charlotte, North Carolina, United States
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Dublin, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Rock Hill, South Carolina, United States
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Spartanburg, South Carolina, United States
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Houston, Texas, United States
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Richmond, Virginia, United States
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Plovdiv, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Velingrad, , Bulgaria
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Brandýs nad Labem, , Czechia
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Hradec Králové, , Czechia
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Mladá Boleslav, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Strakonice, , Czechia
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Balassagyarmat, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Csorna, , Hungary
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Debrecen, , Hungary
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Farkasgyepü, , Hungary
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Gödöllő, , Hungary
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Komárom, , Hungary
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Mátészalka, , Hungary
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Nagykanizsa, , Hungary
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Százhalombatta, , Hungary
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Szeged, , Hungary
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Törökbálint, , Hungary
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Ashkelon, , Israel
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Haifa, , Israel
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Jerusalem, , Israel
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Kfar Saba, , Israel
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Petah Tikva, , Israel
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Rehovot, , Israel
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Tel Litwinsky, , Israel
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Chūōku, , Japan
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Chūōku, , Japan
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Chūōku, , Japan
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Fujisawa-shi, , Japan
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Kiyose-shi, , Japan
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Kurume-shi, , Japan
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Maebashi, , Japan
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Ora-gun, , Japan
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Sagamihara-shi, , Japan
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Saitama-Ken, , Japan
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Sapporo, , Japan
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Taito-ku, , Japan
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Toshima-ku, , Japan
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Yokkaichi-shi, , Japan
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Daugavpils, , Latvia
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Rēzekne, , Latvia
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Riga, , Latvia
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Riga, , Latvia
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Riga, , Latvia
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Riga, , Latvia
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Kaunas, , Lithuania
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Klaipėda, , Lithuania
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Klaipėda, , Lithuania
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Belgrade, , Serbia
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Kamenitz, , Serbia
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Kragujevac, , Serbia
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Bardejov, , Slovakia
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Bratislava, , Slovakia
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Ilava, , Slovakia
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Košice, , Slovakia
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Levice, , Slovakia
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Nové Zámky, , Slovakia
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Poprad, , Slovakia
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Spišská Nová Ves, , Slovakia
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Štúrovo, , Slovakia
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Šurany, , Slovakia
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Topoľčany, , Slovakia
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Zvolen, , Slovakia
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Durban, , South Africa
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Middelburg, , South Africa
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Pretoria, , South Africa
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Pretoria, , South Africa
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Dnipropetrovsk, , Ukraine
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Ivano-Frankivsk, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Mykolayiv, , Ukraine
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Odesa, , Ukraine
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Poltava, , Ukraine
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Suprunivka Vil., Poltava Regio, , Ukraine
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Vinnytsia, , Ukraine
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Zaporizhzhya, , Ukraine
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Zaporizhzhya, , Ukraine
Countries
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References
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Corren J, Parnes JR, Wang L, Mo M, Roseti SL, Griffiths JM, van der Merwe R. Tezepelumab in Adults with Uncontrolled Asthma. N Engl J Med. 2017 Sep 7;377(10):936-946. doi: 10.1056/NEJMoa1704064.
Feleszko W, Caminati M, Gern JE, Johnston SL, Marchese C, Clarke D, Ambrose CS, Lindsley AW. Effect of tezepelumab on asthma exacerbations co-occurring with infection-attributed acute respiratory illnesses. Ann Allergy Asthma Immunol. 2025 Oct 8:S1081-1206(25)01201-3. doi: 10.1016/j.anai.2025.09.015. Online ahead of print.
Pavord ID, Brightling CE, Korn S, Martin NL, Ponnarambil SS, Molfino NA, Parnes JR, Ambrose CS. Tezepelumab can Restore Normal Lung Function in Patients with Severe, Uncontrolled Asthma: Pooled Results from the PATHWAY and NAVIGATOR Studies. Pulm Ther. 2025 Jun;11(2):315-325. doi: 10.1007/s41030-025-00294-2. Epub 2025 Apr 26.
Corren J, Menzies-Gow A, Bimmel J, McGuinness A, Almqvist G, Bowen K, Griffiths JM, Ponnarambil S, Bourdin A, Israel E, Colice G, Brightling CE, Wechsler ME; PATHWAY and NAVIGATOR study investigators. Tezepelumab for the treatment of severe asthma: a plain language summary of the PATHWAY and NAVIGATOR studies. Immunotherapy. 2023 Nov;15(16):1327-1340. doi: 10.2217/imt-2023-0109. Epub 2023 Sep 29.
Corren J, Menzies-Gow A, Chupp G, Israel E, Korn S, Cook B, Ambrose CS, Hellqvist A, Roseti SL, Molfino NA, Llanos JP, Martin N, Bowen K, Griffiths JM, Parnes JR, Colice G. Efficacy of Tezepelumab in Severe, Uncontrolled Asthma: Pooled Analysis of the PATHWAY and NAVIGATOR Clinical Trials. Am J Respir Crit Care Med. 2023 Jul 1;208(1):13-24. doi: 10.1164/rccm.202210-2005OC.
Corren J, Pham TH, Garcia Gil E, Salapa K, Ren P, Parnes JR, Colice G, Griffiths JM. Baseline type 2 biomarker levels and response to tezepelumab in severe asthma. Allergy. 2022 Jun;77(6):1786-1796. doi: 10.1111/all.15197. Epub 2022 Feb 9.
Corren J, Ambrose CS, Salapa K, Roseti SL, Griffiths JM, Parnes JR, Colice G. Efficacy of Tezepelumab in Patients with Severe, Uncontrolled Asthma and Perennial Allergy. J Allergy Clin Immunol Pract. 2021 Dec;9(12):4334-4342.e6. doi: 10.1016/j.jaip.2021.07.045. Epub 2021 Aug 3.
Ly N, Zheng Y, Griffiths JM, van der Merwe R, Agoram B, Parnes JR, Roskos L. Pharmacokinetic and Pharmacodynamic Modeling of Tezepelumab to Guide Phase 3 Dose Selection for Patients With Severe Asthma. J Clin Pharmacol. 2021 Jul;61(7):901-912. doi: 10.1002/jcph.1803. Epub 2021 Jan 16.
Corren J, Garcia Gil E, Griffiths JM, Parnes JR, van der Merwe R, Salapa K, O'Quinn S. Tezepelumab improves patient-reported outcomes in patients with severe, uncontrolled asthma in PATHWAY. Ann Allergy Asthma Immunol. 2021 Feb;126(2):187-193. doi: 10.1016/j.anai.2020.10.008. Epub 2020 Oct 23.
Related Links
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CD-RI-MEDI9929-1146\_Protocol\_Synopsis\_Amendment\_3\_Redacted\_04.03.17
CD-RI-MEDI9929-1146\_Protocol\_Synopsis\_Redacted\_06.23.17
Other Identifiers
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2013-003269-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CD-RI-MEDI9929-1146
Identifier Type: -
Identifier Source: org_study_id
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