Study to Evaluate the Efficacy and Safety of MEDI9929 (AMG 157) in Adult Subjects With Inadequately Controlled, Severe Asthma

NCT02054130 | Completed Phase 2 Results DMC

• 2 other identifiers: CD-RI-MEDI9929-11462013-003269-33
• Study Type: interventional
• Target: 584
• Locations: 12 countries
• Sites: 107

Brief Summary

The primary objective of the study is to evaluate the effect of 3 dose levels of MEDI9929 (AMG 157) on asthma exacerbations in adult subjects with inadequately controlled, severe asthma.

Conditions

Asthma

Keywords

Asthma

Outcome Measures

Primary Outcomes (1)

• Annualized Asthma Exacerbation Rate (AER) Through Week 52

  Asthma exacerbation is defined as worsening of asthma that leads to any of the following: use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma. The annual AER was presented as the total number of exacerbations for the treatment group divided by the total duration of person follow-up.

  Week 0 (Day 1) up to Week 52

Secondary Outcomes (21)

• Reduction in AER on Subpopulations at Week 52

  Week 52

• Change From Baseline in Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Week 52

  Baseline (Week 0 [Day 1]) to Week 52

• Change From Baseline in FEV1 on Subpopulations at Week 52

  Baseline and up to Week 52

• Change From Baseline in Post-bronchodilator (Post-BD) FEV1 and FVC at Week 52

  Baseline (Week 0 [Day 1]) to Week 52

• Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52

  Baseline and up to Week 52

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.

Drug: Placebo

MEDI9929 70 mg

EXPERIMENTAL

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.

Drug: MEDI9929 70 mg

MEDI9929 210 mg

EXPERIMENTAL

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.

Drug: MEDI9929 210 mg

MEDI9929 280 mg

EXPERIMENTAL

Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.

Drug: MEDI9929 280 mg

Interventions

Placebo DRUG

Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.

Placebo

MEDI9929 70 mg DRUG

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

MEDI9929 210 mg DRUG

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

MEDI9929 280 mg DRUG

Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.

MEDI9929 280 mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 through 75
• 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.

You may not qualify if:

• Diagnosis of vocal cord dysfunction, reactive airways dysfunction syndrome, hyperventilation and panic attacks, or other mimics of asthma.
• 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.

Sponsors & Collaborators

• MedImmune LLC: lead
• Amgen: collaborator

Study Sites (107)

Research Site

Los Angeles, California, 90025, United States

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Los Angeles, California, 90048, United States

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Miami, Florida, 33133, United States

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Oviedo, Florida, 32765, United States

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Savannah, Georgia, 31406, United States

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Peoria, Illinois, 61602, United States

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Baltimore, Maryland, 21224, United States

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Rochester, Minnesota, 55905, United States

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New York, New York, 10016, United States

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New York, New York, 10029, United States

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Charlotte, North Carolina, 28207, United States

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Charlotte, North Carolina, 28277, United States

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Dublin, Ohio, 43016, United States

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Oklahoma City, Oklahoma, 73120, United States

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Rock Hill, South Carolina, 29732, United States

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Spartanburg, South Carolina, 29303, United States

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Houston, Texas, 77070, United States

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Richmond, Virginia, 23220, United States

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Plovdiv, 4002, Bulgaria

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Sofia, 1202, Bulgaria

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Sofia, 1233, Bulgaria

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Sofia, 1431, Bulgaria

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Sofia, 1606, Bulgaria

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Sofia, 1750, Bulgaria

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Velingrad, 4600, Bulgaria

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Brandýs nad Labem, 250 01, Czechia

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Hradec Králové, 500 05, Czechia

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Mladá Boleslav, 293 01, Czechia

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Prague, 14059, Czechia

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Prague, 180 00, Czechia

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Prague, 180 81, Czechia

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Strakonice, 38601, Czechia

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Balassagyarmat, 2660, Hungary

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Budapest, 1033, Hungary

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Budapest, 1125, Hungary

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Budapest, 1529, Hungary

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Csorna, 9300, Hungary

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Debrecen, 4032, Hungary

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Farkasgyepü, 8582, Hungary

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Gödöllő, 2100, Hungary

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Komárom, 2900, Hungary

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Mátészalka, 4700, Hungary

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Nagykanizsa, 8800, Hungary

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Százhalombatta, 2440, Hungary

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Szeged, H-6722, Hungary

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Törökbálint, 2045, Hungary

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Ashkelon, 78278, Israel

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Haifa, 34362, Israel

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Jerusalem, 91120, Israel

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Kfar Saba, 44281, Israel

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Petah Tikva, Israel

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Rehovot, 7661041, Israel

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Tel Litwinsky, 52621, Israel

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Chūōku, 103-0027, Japan

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Chūōku, 103-0028, Japan

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Chūōku, 104-8560, Japan

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Fujisawa-shi, 251-8550, Japan

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Kiyose-shi, 204-8585, Japan

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Kurume-shi, 830-0011, Japan

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Maebashi, 371-0054, Japan

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Ora-gun, 370-0615, Japan

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Sagamihara-shi, 228-0815, Japan

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Saitama-Ken, 338-8553, Japan

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Sapporo, 060-0033, Japan

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Taito-ku, 111-0051, Japan

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Toshima-ku, 171-0014, Japan

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Yokkaichi-shi, 510-8567, Japan

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Daugavpils, LV-5401, Latvia

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Rēzekne, LV-4600, Latvia

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Riga, 1001, Latvia

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Riga, LV-1038, Latvia

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Riga, LV1002, Latvia

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Riga, LV1010, Latvia

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Kaunas, LT50009, Lithuania

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Klaipėda, 92231, Lithuania

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Klaipėda, 92288, Lithuania

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Belgrade, 11000, Serbia

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Kamenitz, 21204, Serbia

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Kragujevac, 34000, Serbia

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Bardejov, 085 01, Slovakia

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Bratislava, 84108, Slovakia

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Ilava, 01901, Slovakia

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Košice, 040 01, Slovakia

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Levice, 934 01, Slovakia

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Nové Zámky, 940 01, Slovakia

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Poprad, 058 01, Slovakia

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Spišská Nová Ves, 052 01, Slovakia

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Štúrovo, 94301, Slovakia

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Šurany, 94201, Slovakia

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Topoľčany, 95501, Slovakia

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Zvolen, 96001, Slovakia

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Durban, 4068, South Africa

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Middelburg, 1055, South Africa

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Pretoria, 0181, South Africa

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Pretoria, 0183, South Africa

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Dnipropetrovsk, 49051, Ukraine

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Ivano-Frankivsk, 76012, Ukraine

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Kyiv, 02091, Ukraine

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Kyiv, 03680, Ukraine

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Kyiv, 04050, Ukraine

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Mykolayiv, 54003, Ukraine

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Odesa, 65039, Ukraine

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Poltava, 36038, Ukraine

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Suprunivka Vil., Poltava Regio, 36028, Ukraine

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Vinnytsia, 21029, Ukraine

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Zaporizhzhya, 69035, Ukraine

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Zaporizhzhya, 69600, Ukraine

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Related Publications (9)

• 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.

  PMID: 28877011 BACKGROUND

• 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. 2026 Jan;136(1):61-65.e1. doi: 10.1016/j.anai.2025.09.015. Epub 2025 Oct 8.

  PMID: 41072729 DERIVED

• 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.

  PMID: 40285963 DERIVED

• 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.

  PMID: 37772607 DERIVED

• 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.

  PMID: 37015033 DERIVED

• 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.

  PMID: 34913186 DERIVED

• 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.

  PMID: 34358701 DERIVED

• 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.

  PMID: 33368307 DERIVED

• 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.

  PMID: 33169672 DERIVED

Related Links

• CD-RI-MEDI9929-1146\_Protocol\_Synopsis\_Amendment\_3\_Redacted\_04.03.17
• CD-RI-MEDI9929-1146\_Protocol\_Synopsis\_Redacted\_06.23.17

MeSH Terms

Conditions

Asthma

Interventions

tezepelumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Limitations and Caveats

A non-pre-specified statistical analysis was performed and generated the Measure of Dispersion for Outcome Measures 4 and 6.

Results Point of Contact

• Title: Fred Reid
• Organization: MedImmune, LLC

information.center@astrazeneca.com

+44 (0) 203 749 6512

Study Officials

• MedImmune LLC

  MedImmune LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2013
• First Posted: February 4, 2014
• Study Start: December 13, 2013
• Primary Completion: December 12, 2016
• Study Completion: March 1, 2017
• Last Updated: December 4, 2018
• Results First Posted: December 4, 2018

Record last verified: 2018-11

Locations

SL (12); JP (14); ZA (4); LA (6); US (18); IL (7); SE (3); UA (12); CZ (7); HU (14); BU (7); LI (3)