Asthma Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma
| Verified date | November 2015 |
| Source | Sanofi |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
Primary Objective:
To evaluate the efficacy of different doses and regimens of dupilumab in patients with
moderate to severe uncontrolled asthma
Secondary Objective:
To evaluate different doses and regimens of dupilumab in patients with moderate to severe
uncontrolled asthma, with regard to:
- Safety and tolerability
- Dupilumab systemic exposure and anti-drug antibodies
| Status | Completed |
| Enrollment | 776 |
| Est. completion date | April 2015 |
| Est. primary completion date | November 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion criteria: Patients with a physician diagnosis of moderate to severe, uncontrolled asthma for =12 months, based on the Global Initiative for Asthma (GINA) 2009 Guidelines and: - Existing treatment with moderate- or high-dose inhaled corticosteroid / long-acting beta-2 agonist - Forced expiratory volume (FEV1) 40 to 80% of predicted normal - Juniper Asthma Control Questionnaire, 5-question version (ACQ-5) score =1.5 - Reversibility of at least 12% and 200 mL in forced expiratory volume (FEV1) - Has experienced, within prior year: hospitalization, emergency or urgent care visit or systemic corticosteroid treatment for worsening asthma Exclusion criteria: - Patients <18 years - Chronic obstructive pulmonary disease (COPD) or other lung diseases (eg, emphysema, idiopathic pulmonary fibrosis, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis) which impair pulmonary function tests - Chest X-ray within 12 months of screening visit or at screening visit with clinically significant findings of lung disease(s) other than asthma - Current smoker or cessation of smoking within 6 months prior to Visit 1 - Previous smoker with a smoking history >10 pack-years The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Investigational Site Number 032003 | Buenos Aires | |
| Argentina | Investigational Site Number 032004 | Buenos Aires | |
| Argentina | Investigational Site Number 032001 | Caba | |
| Argentina | Investigational Site Number 032008 | Caba | |
| Argentina | Investigational Site Number 032010 | Caba | |
| Argentina | Investigational Site Number 032002 | La Plata | |
| Argentina | Investigational Site Number 032005 | Rosario | |
| Argentina | Investigational Site Number 032006 | Rosario | |
| Argentina | Investigational Site Number 032007 | Rosario | |
| Argentina | Investigational Site Number 032012 | Santa Fe | |
| Argentina | Investigational Site Number 032009 | Tucumán | |
| Australia | Investigational Site Number 036004 | Adelaide | |
| Australia | Investigational Site Number 036002 | Brisbane | |
| Australia | Investigational Site Number 036005 | Campbelltown | |
| Australia | Investigational Site Number 036001 | Clayton | |
| Australia | Investigational Site Number 036008 | Frankston | |
| Australia | Investigational Site Number 036003 | Nedlands | |
| Australia | Investigational Site Number 036009 | Prahran | |
| Australia | Investigational Site Number 036006 | Woolloongabba | |
| Chile | Investigational Site Number 152007 | Quillota | |
| Chile | Investigational Site Number 152001 | Santiago | |
| Chile | Investigational Site Number 152002 | Santiago | |
| Chile | Investigational Site Number 152003 | Santiago | |
| Chile | Investigational Site Number 152005 | Santiago | |
| Chile | Investigational Site Number 152011 | Santiago | |
| Chile | Investigational Site Number 152012 | Santiago | |
| Chile | Investigational Site Number 152013 | Santiago | |
| Chile | Investigational Site Number 152014 | Santiago | |
| Chile | Investigational Site Number 152008 | Talca | |
| Chile | Investigational Site Number 152006 | Viña Del Mar | |
| France | Investigational Site Number 250009 | Brest Cedex | |
| France | Investigational Site Number 250004 | Grenoble Cedex 09 | |
| France | Investigational Site Number 250010 | Lille | |
| France | Investigational Site Number 250006 | Lyon | |
| France | Investigational Site Number 250001 | Marseille | |
| France | Investigational Site Number 250002 | Montpellier | |
| France | Investigational Site Number 250005 | Nantes | |
| France | Investigational Site Number 250007 | Nimes | |
| France | Investigational Site Number 250003 | Pessac | |
| France | Investigational Site Number 250008 | Strasbourg | |
| France | Investigational Site Number 250011 | Vernon | |
| Italy | Investigational Site Number 380010 | Ancona | |
| Italy | Investigational Site Number 380009 | Catania | |
| Italy | Investigational Site Number 380004 | Ferrara | |
| Italy | Investigational Site Number 380002 | Firenze | |
| Italy | Investigational Site Number 380008 | Foggia | |
| Italy | Investigational Site Number 380003 | Modena | |
| Italy | Investigational Site Number 380007 | Padova | |
| Italy | Investigational Site Number 380001 | Pisa | |
| Italy | Investigational Site Number 380005 | Torino | |
| Italy | Investigational Site Number 380006 | Verona | |
| Japan | Investigational Site Number 392009 | Asahi-Shi | |
| Japan | Investigational Site Number 392037 | Chiyoda-Ku | |
| Japan | Investigational Site Number 392002 | Chuo-Ku | |
| Japan | Investigational Site Number 392007 | Chuoh-Ku | |
| Japan | Investigational Site Number 392012 | Edogawa-Ku | |
| Japan | Investigational Site Number 392017 | Fukuoka-Shi | |
| Japan | Investigational Site Number 392021 | Fukuyama-Shi | |
| Japan | Investigational Site Number 392030 | Habikino-Shi | |
| Japan | Investigational Site Number 392004 | Himeji-Shi | |
| Japan | Investigational Site Number 392032 | Hirakata-Shi | |
| Japan | Investigational Site Number 392013 | Iizuka-Shi | |
| Japan | Investigational Site Number 392042 | Isesaki-Shi | |
| Japan | Investigational Site Number 392026 | Itabashi-Ku | |
| Japan | Investigational Site Number 392023 | Kanazawa-Shi | |
| Japan | Investigational Site Number 392001 | Kitakyushu-Shi | |
| Japan | Investigational Site Number 392022 | Kiyose-Shi | |
| Japan | Investigational Site Number 392025 | Kobe-Shi | |
| Japan | Investigational Site Number 392040 | Kodaira-Shi | |
| Japan | Investigational Site Number 392044 | Kokubunji-Shi | |
| Japan | Investigational Site Number 392010 | Kurashiki-Shi | |
| Japan | Investigational Site Number 392036 | Kyoto-Shi | |
| Japan | Investigational Site Number 392041 | Nagaoka-Shi | |
| Japan | Investigational Site Number 392020 | Naka-Gun | |
| Japan | Investigational Site Number 392015 | Nakano-Ku | |
| Japan | Investigational Site Number 392005 | Naruto-Shi | |
| Japan | Investigational Site Number 392043 | Ohta-Shi | |
| Japan | Investigational Site Number 392019 | Sagamihara-Shi | |
| Japan | Investigational Site Number 392024 | Sakai-Shi | |
| Japan | Investigational Site Number 392011 | Sakaide-Shi | |
| Japan | Investigational Site Number 392008 | Sapporo-Shi | |
| Japan | Investigational Site Number 392034 | Sapporo-Shi | |
| Japan | Investigational Site Number 392038 | Setagaya-Ku | |
| Japan | Investigational Site Number 392028 | Sumida-Ku | |
| Japan | Investigational Site Number 392006 | Tomakomai-Shi | |
| Japan | Investigational Site Number 392003 | Toride-Shi | |
| Japan | Investigational Site Number 392029 | Tsu-Shi | |
| Japan | Investigational Site Number 392018 | Tsukubo-Gun | |
| Japan | Investigational Site Number 392045 | Uruma-Shi | |
| Japan | Investigational Site Number 392014 | Yokohama-Shi | |
| Japan | Investigational Site Number 392035 | Yokohama-Shi | |
| Korea, Republic of | Investigational Site Number 410002 | Bucheon | |
| Korea, Republic of | Investigational Site Number 410003 | Cheongju | |
| Korea, Republic of | Investigational Site Number 410004 | Seoul | |
| Korea, Republic of | Investigational Site Number 410005 | Seoul | |
| Korea, Republic of | Investigational Site Number 410001 | Suwon | |
| Mexico | Investigational Site Number 484006 | Chihuahua | |
| Mexico | Investigational Site Number 484005 | Distrito Federal | |
| Mexico | Investigational Site Number 484001 | Guadalajara | |
| Mexico | Investigational Site Number 484004 | Mexico City | |
| Mexico | Investigational Site Number 484003 | Monterrey | |
| New Zealand | Investigational Site Number 554001 | Dunedin | |
| New Zealand | Investigational Site Number 554002 | Wellington | |
| Poland | Investigational Site Number 616006 | Bialystok | |
| Poland | Investigational Site Number 616003 | Gdansk | |
| Poland | Investigational Site Number 616004 | Gdansk | |
| Poland | Investigational Site Number 616007 | Krakow | |
| Poland | Investigational Site Number 616001 | Lodz | |
| Poland | Investigational Site Number 616005 | Lodz | |
| Poland | Investigational Site Number 616008 | Warszawa | |
| Russian Federation | Investigational Site Number 643001 | Moscow | |
| Russian Federation | Investigational Site Number 643002 | Moscow | |
| Russian Federation | Investigational Site Number 643003 | Moscow | |
| Russian Federation | Investigational Site Number 643007 | Moscow | |
| Russian Federation | Investigational Site Number 643012 | Moscow | |
| Russian Federation | Investigational Site Number 643006 | Novosibirsk | |
| Russian Federation | Investigational Site Number 643010 | Saint-Petersburg | |
| Russian Federation | Investigational Site Number 643011 | Saint-Petersburg | |
| Russian Federation | Investigational Site Number 643009 | St-Petersburg | |
| Russian Federation | Investigational Site Number 643008 | Yaroslavl | |
| South Africa | Investigational Site Number 710001 | Cape Town | |
| South Africa | Investigational Site Number 710002 | Cape Town | |
| Spain | Investigational Site Number 724001 | Barcelona | |
| Spain | Investigational Site Number 724002 | Barcelona | |
| Spain | Investigational Site Number 724005 | Barcelona | |
| Spain | Investigational Site Number 724004 | Cáceres | |
| Spain | Investigational Site Number 724006 | Pozuelo De Alarcón | |
| Spain | Investigational Site Number 724003 | Sabadell | |
| Spain | Investigational Site Number 724007 | Sant Boi De Llobregat | |
| Turkey | Investigational Site Number 792011 | Amasya | |
| Turkey | Investigational Site Number 792002 | Ankara | |
| Turkey | Investigational Site Number 792008 | Bursa | |
| Turkey | Investigational Site Number 792001 | Istanbul | |
| Turkey | Investigational Site Number 792003 | Istanbul | |
| Turkey | Investigational Site Number 792004 | Istanbul | |
| Turkey | Investigational Site Number 792007 | Istanbul | |
| Turkey | Investigational Site Number 792005 | Izmir | |
| Turkey | Investigational Site Number 792013 | Kirikkale | |
| Turkey | Investigational Site Number 792006 | Mersin | |
| Ukraine | Investigational Site Number 804016 | Donetsk | |
| Ukraine | Investigational Site Number 804001 | Kharkiv | |
| Ukraine | Investigational Site Number 804003 | Kyiv | |
| Ukraine | Investigational Site Number 804004 | Kyiv | |
| Ukraine | Investigational Site Number 804008 | Kyiv | |
| Ukraine | Investigational Site Number 804018 | Kyiv | |
| Ukraine | Investigational Site Number 804020 | Kyiv | |
| Ukraine | Investigational Site Number 804006 | Odessa | |
| Ukraine | Investigational Site Number 804002 | Poltava | |
| Ukraine | Investigational Site Number 804019 | Vinnytsya | |
| Ukraine | Investigational Site Number 804015 | Yalta | |
| Ukraine | Investigational Site Number 804012 | Zaporozhye | |
| United States | Investigational Site Number 840048 | Albany | Georgia |
| United States | Investigational Site Number 840028 | Baltimore | Maryland |
| United States | Investigational Site Number 840015 | Cincinnati | Ohio |
| United States | Investigational Site Number 840020 | Cincinnati | Ohio |
| United States | Investigational Site Number 840025 | Cincinnati | Ohio |
| United States | Investigational Site Number 840032 | Colorado Springs | Colorado |
| United States | Investigational Site Number 840040 | Colorado Springs | Colorado |
| United States | Investigational Site Number 840023 | Dallas | Texas |
| United States | Investigational Site Number 840027 | Daytona Beach | Florida |
| United States | Investigational Site Number 840006 | Denver | Colorado |
| United States | Investigational Site Number 840024 | Denver | Colorado |
| United States | Investigational Site Number 840043 | Denver | Colorado |
| United States | Investigational Site Number 840005 | El Paso | Texas |
| United States | Investigational Site Number 840053 | Evansville | Indiana |
| United States | Investigational Site Number 840054 | Everett | Washington |
| United States | Investigational Site Number 840050 | Fullerton | California |
| United States | Investigational Site Number 840041 | Huntington Beach | California |
| United States | Investigational Site Number 840031 | Lake Oswego | Oregon |
| United States | Investigational Site Number 840019 | Los Angeles | California |
| United States | Investigational Site Number 840022 | Los Angeles | California |
| United States | Investigational Site Number 840029 | Los Angeles | California |
| United States | Investigational Site Number 840017 | Louisville | Kentucky |
| United States | Investigational Site Number 840034 | Medford | Oregon |
| United States | Investigational Site Number 840039 | Miami | Florida |
| United States | Investigational Site Number 840018 | Minneapolis | Minnesota |
| United States | Investigational Site Number 840013 | Mission Viejo | California |
| United States | Investigational Site Number 840037 | Missoula | Montana |
| United States | Investigational Site Number 840044 | Newport Beach | California |
| United States | Investigational Site Number 840045 | North Dartmouth | Massachusetts |
| United States | Investigational Site Number 840046 | Novi | Michigan |
| United States | Investigational Site Number 840051 | Novi | Michigan |
| United States | Investigational Site Number 840001 | Oklahoma City | Oklahoma |
| United States | Investigational Site Number 840030 | Owensboro | Kentucky |
| United States | Investigational Site Number 840004 | Papillion | Nebraska |
| United States | Investigational Site Number 840042 | Philadelphia | Pennsylvania |
| United States | Investigational Site Number 840010 | Pittsburgh | Pennsylvania |
| United States | Investigational Site Number 840011 | Princeton | New Jersey |
| United States | Investigational Site Number 840035 | Richmond | Virginia |
| United States | Investigational Site Number 840026 | River Forest | Illinois |
| United States | Investigational Site Number 840007 | Riverside | California |
| United States | Investigational Site Number 840016 | Rochester | New York |
| United States | Investigational Site Number 840014 | Rolling Hills Estates | California |
| United States | Investigational Site Number 840008 | San Antonio | Texas |
| United States | Investigational Site Number 840036 | San Jose | California |
| United States | Investigational Site Number 840021 | Spartanburg | South Carolina |
| United States | Investigational Site Number 840002 | St Louis | Missouri |
| United States | Investigational Site Number 840003 | St Louis | Missouri |
| United States | Investigational Site Number 840033 | Tacoma | Washington |
| United States | Investigational Site Number 840009 | Upland | Pennsylvania |
| United States | Investigational Site Number 840052 | Wheaton | Maryland |
| Lead Sponsor | Collaborator |
|---|---|
| Sanofi | Regeneron Pharmaceuticals |
United States, Argentina, Australia, Chile, France, Italy, Japan, Korea, Republic of, Mexico, New Zealand, Poland, Russian Federation, South Africa, Spain, Turkey, Ukraine,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from baseline in forced expiratory volume (FEV1) | Week 12 | No | |
| Secondary | Relative change from baseline in FEV1 | Week 12 | No | |
| Secondary | Annualized rate of loss of asthma control | Week 24 | No | |
| Secondary | Time to loss of asthma control | Week 24 | No | |
| Secondary | Change from baseline in asthma symptom scores | Week 12 | No |
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