A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma

NCT02194699 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: D2210C00008
• Study Type: interventional
• Target: 856
• Locations: 13 countries
• Sites: 234

Brief Summary

A 52-Week, Multicentre, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents with Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist

Conditions

Uncontrolled Asthma

Outcome Measures

Primary Outcomes (1)

• Annualised Asthma Exacerbation Rate (AAER) up to Week 52

  Asthma exacerbation was defined as a worsening of asthma that led to any of the following: * Use of systemic corticosteroids for at least 3 days; a single depo-injectable dose of corticosteroids was considered equivalent to a 3-day course of systemic corticosteroids. * An emergency room (ER) or urgent care (UC) visit (defined as evaluation and treatment for \<24 hours in an ER or UC centre) due to asthma that required systemic corticosteroids (see above). * An inpatient hospitalisation (defined as admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for ≥24 hours) due to asthma. AAER = number of exacerbations\*365.25 / (follow-up date - date of randomisation + 1) (where maximum follow-up time for a patient was approximately 52 weeks). AAER in the tralokinumab group was compared to that seen in the placebo group up to Week 52 using a negative binomial model; rate ratios and rate reductions are both presented for comparative statistical analyses.

  Baseline (Week 0) up to Week 52

Secondary Outcomes (17)

• Percent Change From Baseline to Week 52 in Pre-dose/Pre-bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV1)

  Baseline (Week 0) and Week 52

• Change From Baseline to Week 52 in Total Asthma Symptom Score (Bi-weekly Means)

  Baseline (Week 0) and Week 52

• Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) Total Score

  Baseline (Week 0) and Week 52

• Change From Baseline to Week 52 in Asthma Control Questionnaire-6 (ACQ-6) Score

  Baseline (Week 0) and Week 52

• AAER Associated With an ER/UC Visit, or a Hospitalisation up to Week 52

  Baseline (Week 0) up to Week 52

Study Arms (2)

Tralokinumab

EXPERIMENTAL

Tralokinumab subcutaneous injection

Biological: Experimental: Tralokinumab

Placebo

PLACEBO COMPARATOR

Placebo subcutaneous injection

Other: Placebo

Interventions

Experimental: Tralokinumab BIOLOGICAL

Tralokinumab subcutaneous injection

Tralokinumab

Placebo OTHER

Placebo subcutaneous injection

Placebo

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 12 -75
• Documented physician-diagnosed asthma.
• Documented treatment with ICS at a total daily dose corresponding to ≥500μg fluticasone propionate dry powder formulation equivalents) and a LABA
• Morning pre-BD FEV1 value of ≥40 and \<80% value (\<90% for patients 12 to 17 years of age) of their PNV.
• Post-BD reversibility of ≥12% and ≥200 mL in FEV1
• ACQ-6 score ≥1.5

You may not qualify if:

• Pulmonary disease other than asthma
• History of anaphylaxis following any biologic therapy
• Hepatitis B, C or HIV
• Pregnant or breastfeeding
• History of cancer
• Current tobacco smoking or a history of tobacco smoking for ≥ 10 pack-years
• Previous receipt of tralokinumab

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (234)

Research Site

Birmingham, Alabama, 35294, United States

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Hoover, Alabama, 35244, United States

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Huntsville, Alabama, 35803, United States

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Scottsdale, Arizona, 85251, United States

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Little Rock, Arkansas, 72209, United States

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Bakersfield, California, 93301, United States

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Buena Park, California, 90620, United States

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Encinitas, California, 92024, United States

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Lakewood, California, 90805, United States

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Lomita, California, 90717, United States

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Northridge, California, 91324, United States

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Palmdale, California, 93551, United States

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Roseville, California, 95661, United States

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Sacramento, California, 95819, United States

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San Francisco, California, 94102, United States

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Thousand Oaks, California, 91360, United States

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Ventura, California, 93003-3099, United States

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Walnut Creek, California, 94598, United States

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Centennial, Colorado, 80112, United States

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Celebration, Florida, 34747, United States

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DeLand, Florida, 32720, United States

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Gainesville, Florida, 32607, United States

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Hialeah, Florida, 33016, United States

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Miami, Florida, 33126, United States

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Miami, Florida, 33134, United States

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Miami, Florida, 33142, United States

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Miami, Florida, 33144, United States

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Miami, Florida, 33155, United States

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Miami, Florida, 33165, United States

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Miami, Florida, 33176, United States

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New Port Richey, Florida, 34653, United States

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Orlando, Florida, 32819, United States

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Palmetto Bay, Florida, 33157, United States

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Port Charlotte, Florida, 33952, United States

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St. Petersburg, Florida, 33710, United States

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Tampa, Florida, 33607, United States

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Winter Park, Florida, 32789, United States

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Columbus, Georgia, 31904, United States

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Gainesville, Georgia, 30501, United States

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Savannah, Georgia, 31406, United States

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Eagle, Idaho, 83616, United States

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Evergreen Park, Illinois, 60805, United States

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Kenilworth, Illinois, 60043, United States

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Peoria, Illinois, 61602, United States

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White Marsh, Maryland, 21162, United States

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Fall River, Massachusetts, 02720, United States

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Reno, Nevada, 89503, United States

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Northfield, New Jersey, 08225, United States

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Ocean City, New Jersey, 07712, United States

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Teaneck, New Jersey, 07666, United States

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Toms River, New Jersey, 08755, United States

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Verona, New Jersey, 07044, United States

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Albuquerque, New Mexico, 87131, United States

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Larchmont, New York, 10538, United States

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The Bronx, New York, 10459, United States

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The Bronx, New York, 10461, United States

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Wappingers Falls, New York, 12590, United States

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Burlington, North Carolina, 27215, United States

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Charlotte, North Carolina, 28205, United States

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Greensboro, North Carolina, 27410, United States

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Canton, Ohio, 44718, United States

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Cincinnati, Ohio, 45231, United States

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Oklahoma City, Oklahoma, 73120, United States

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Tulsa, Oklahoma, 74135, United States

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Tulsa, Oklahoma, 74136, United States

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Philadelphia, Pennsylvania, 19140, United States

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Rock Hill, South Carolina, 29732, United States

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Arlington, Texas, 76018, United States

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Baytown, Texas, 77521, United States

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Frisco, Texas, 75034, United States

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Houston, Texas, 77043, United States

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Houston, Texas, 77083, United States

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Houston, Texas, 77089, United States

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Kingwood, Texas, 77339, United States

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San Antonio, Texas, 78212, United States

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San Antonio, Texas, 78251, United States

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Orem, Utah, 84058, United States

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Salt Lake City, Utah, 84132, United States

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Fairfax, Virginia, 22030, United States

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Greenfield, Wisconsin, 53228, United States

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Madison, Wisconsin, 53792, United States

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Milwaukee, Wisconsin, 53226, United States

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Sherwood Park, Alberta, T8L 0N2, Canada

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Vancouver, British Columbia, V5Z 1M9, Canada

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Ajax, Ontario, L1S 2J5, Canada

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Ajax, Ontario, L1Z 0M1, Canada

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Burlington, Ontario, L7N 3V2, Canada

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London, Ontario, N6A 1V2, Canada

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Mississauga, Ontario, L5A 3V4, Canada

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Ottawa, Ontario, K1G 6C6, Canada

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Toronto, Ontario, M4V 1R2, Canada

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Windsor, Ontario, N8X 5A6, Canada

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Montreal, Quebec, H4J 1C5, Canada

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Québec, Quebec, G1G 3Y8, Canada

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Québec, Quebec, G1V 4W2, Canada

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Saint-Charles-Borromée, Quebec, J6E 2B4, Canada

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Saskatoon, Saskatchewan, S7N 0W8, Canada

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Santiago, 7500698, Chile

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Santiago, 7750495, Chile

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Santiago, 7980378, Chile

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Santiago, 8380453, Chile

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Santiago, 8910131, Chile

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Talcahuano, 4270918, Chile

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Brandýs nad Labem, 250 01, Czechia

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Jindřichův Hradec, 377 01, Czechia

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Prague, 130 00, Czechia

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Praha 10 - Strasnice, 100 00, Czechia

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Rokycany, 337 22, Czechia

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Teplice, 415 01, Czechia

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Catania, 95123, Italy

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Genova, 16132, Italy

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Legnago, 37045, Italy

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Messina, 98124, Italy

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Milan, 20122, Italy

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Napoli, 80131, Italy

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Palermo, 90146, Italy

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Pisa, 56124, Italy

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Salerno, 84131, Italy

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Verona, 37126, Italy

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Asahi-shi, 289-2511, Japan

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Chūōku, 103-0027, Japan

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Fukui-shi, 910-8526, Japan

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Fukushima, 960-1295, Japan

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Habikino-shi, 583-8588, Japan

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Himeji-shi, 672-8064, Japan

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Hiroshima, 732-0052, Japan

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Itabashi-ku, 173-8610, Japan

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Izumo-shi, 693-8501, Japan

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Kagoshima, 890-0064, Japan

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Kanazawa, 920-8641, Japan

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Kanuma-shi, 322-0036, Japan

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Kasuga-shi, 816-0813, Japan

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Kishiwada-shi, 596-8501, Japan

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Kobe, 650-0047, Japan

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Kobe, 653-0013, Japan

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Kochi, 780-8077, Japan

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Maebashi, 371-8511, Japan

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Matsue, 690-8556, Japan

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Matsusaka-shi, 515-8544, Japan

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Meguro-ku, 153-8515, Japan

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Minatoku, 108-8642, Japan

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Morioka, 020-8505, Japan

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Nagasaki, 852-8501, Japan

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Nagoya, 467-0001, Japan

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Nishinomiya-shi, 663-8501, Japan

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Sagamihara-shi, 228-0815, Japan

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Sakaide-shi, 762-8550, Japan

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Sapporo, 064-0807, Japan

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Sasebo-shi, 857-8511, Japan

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Seto-shi, 489-8642, Japan

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Shibuya-ku, 150-0013, Japan

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Shinagawa-ku, 142-8666, Japan

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Shinjuku-ku, 162-8655, Japan

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Sumida-ku, 130-8587, Japan

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Takamatsu, 760-0018, Japan

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Toshima-ku, 171-0014, Japan

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Touon-shi, 791-0281, Japan

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Toyama, 930-0859, Japan

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Tsu, 514-8507, Japan

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Tsukubo-gun, 701-0304, Japan

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Uozu-shi, 937-0042, Japan

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Yokohama, 227-8501, Japan

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Yokohama, 231-8682, Japan

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Yokohama, 232-0024, Japan

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Yokohama, 232-0066, Japan

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Yokohama, 236-0051, Japan

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Guadalajara, 44100, Mexico

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México, 07760, Mexico

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Monterrey, 64460, Mexico

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Monterrey, 66465, Mexico

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Villahermosa, 86035, Mexico

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Caloocan, 1400, Philippines

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Iloilo City, 5000, Philippines

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Lipa City, Philippines

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Pasig, 1000, Philippines

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Quezon City, 1101, Philippines

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Quezon City, 1109, Philippines

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San Fernando City, 2000, Philippines

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Chelyabinsk, 454021, Russia

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Izhevsk, 426035, Russia

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Moscow, 115682, Russia

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Moscow, 127473, Russia

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Novosibirsk, 630008, Russia

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Novosibirsk, 630084, Russia

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Novosibirsk, 630117, Russia

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Omsk, 644043, Russia

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Perm, 614000, Russia

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Petrozavodsk, 185019, Russia

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Pyatigorsk, 357538, Russia

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Saint Petersburg, 194354, Russia

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Saint Petersburg, 196211, Russia

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Saint Petersburg, 196601, Russia

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Saint Petersburg, 197022, Russia

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Saratov, 410012, Russia

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Ulyanovsk, 432009, Russia

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Vladikavkaz, 362007, Russia

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Volgograd, 400001, Russia

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Yaroslavl, 150002, Russia

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Yekaterinburg, 620039, Russia

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Boksburg North, 1460, South Africa

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Durban, 4092, South Africa

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KwaDukuza, 4450, South Africa

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Mount Edgecombe, 4302, South Africa

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Mowbray, 7700, South Africa

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Port Elizabeth, 6001, South Africa

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Kaohsiung Hsien, TAIWAN, Taiwan

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Keelung, Taiwan

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New Taipei City, 22056, Taiwan

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Cherkasy, 18009, Ukraine

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Dnipropetrovsk, 49051, Ukraine

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Ivano-Frankivsk, 76012, Ukraine

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Kharkiv, 61035, Ukraine

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Kharkiv, 61075, Ukraine

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Kremenchuk, 39617, Ukraine

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Kyiv, 03049, Ukraine

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Kyiv, 03680, Ukraine

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Kyiv, 04050, Ukraine

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Lviv, 79010, Ukraine

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Odesa, 65025, Ukraine

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Sumy, 40000, Ukraine

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Sumy, 40022, Ukraine

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Uzhhorod, 88009, Ukraine

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Zaporizhzhya, 69068, Ukraine

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Zaporizhzhya, 69114, Ukraine

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Bradford, BD9 6RJ, United Kingdom

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Cambridge, CB2 0QQ, United Kingdom

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Chertsey, KT16 0PZ, United Kingdom

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Glasgow, G12 OYN, United Kingdom

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Leicester, LE3 9QP, United Kingdom

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Liverpool, L7 8XP, United Kingdom

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Manchester, M23 9QZ, United Kingdom

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Northwood, HA6 2RN, United Kingdom

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Sidcup, DA14 6LT, United Kingdom

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Wishaw, ML2 0DP, United Kingdom

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Related Publications (4)

• Gottlow M, Svensson DJ, Lipkovich I, Huhn M, Bowen K, Wessman P, Colice G. Application of structured statistical analyses to identify a biomarker predictive of enhanced tralokinumab efficacy in phase III clinical trials for severe, uncontrolled asthma. BMC Pulm Med. 2019 Jul 17;19(1):129. doi: 10.1186/s12890-019-0889-4.

  PMID: 31315668 DERIVED

• Carlsson M, Braddock M, Li Y, Wang J, Xu W, White N, Megally A, Hunter G, Colice G. Evaluation of Antibody Properties and Clinically Relevant Immunogenicity, Anaphylaxis, and Hypersensitivity Reactions in Two Phase III Trials of Tralokinumab in Severe, Uncontrolled Asthma. Drug Saf. 2019 Jun;42(6):769-784. doi: 10.1007/s40264-018-00788-w.

  PMID: 30649752 DERIVED

• Panettieri RA Jr, Sjobring U, Peterffy A, Wessman P, Bowen K, Piper E, Colice G, Brightling CE. Tralokinumab for severe, uncontrolled asthma (STRATOS 1 and STRATOS 2): two randomised, double-blind, placebo-controlled, phase 3 clinical trials. Lancet Respir Med. 2018 Jul;6(7):511-525. doi: 10.1016/S2213-2600(18)30184-X. Epub 2018 May 20.

  PMID: 29792288 DERIVED

• Panettieri RA Jr, Wang M, Braddock M, Bowen K, Colice G. Tralokinumab for the treatment of severe, uncontrolled asthma: the ATMOSPHERE clinical development program. Immunotherapy. 2018 Mar 1;10(6):473-490. doi: 10.2217/imt-2017-0191. Epub 2018 Mar 14.

  PMID: 29536781 DERIVED

Results Point of Contact

• Title: Global Clinical Lead
• Organization: AstraZeneca

ClinicalTrialTransparency@astrazeneca.com

+1 301-398-0582

Study Officials

• Christopher Brightling, MD

  Institute for Lung Health, United Kingdom

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2014
• First Posted: July 18, 2014
• Study Start: October 30, 2014
• Primary Completion: May 10, 2017
• Study Completion: September 21, 2017
• Last Updated: May 15, 2018
• Results First Posted: March 21, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (15); TW (3); US (82); ZA (6); GB (10); CL (6); IT (10); ME (5); CZ (6); PH (7); UA (16); JP (47); RU (21)