Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE)

PHASE3CompletedINTERVENTIONAL
Enrollment

555

Participants

Timeline

Start Date

December 22, 2015

Primary Completion Date

December 21, 2017

Study Completion Date

July 2, 2018

Conditions
Peanut Allergy
Interventions
BIOLOGICAL

AR101 powder provided in capsules & sachets

Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol

BIOLOGICAL

Placebo powder provided in capsules & sachets

Study product formulated to contain only inactive ingredients for use as defined in the protocol

Trial Locations (69)

10029

Icahn School of Medicine at Mount Sinai, Clinical Research Unit, New York

10032

Columbia University Medical Center, New York

13353

Charite Universitaetsmedizin Berlin, Berlin

15224

Children's Hospital of Pittsburgh of UPMC, Pittsburgh

19104

Children's Hospital of Philadelphia: Allergy / Immunology, Philadelphia

20010

Children's National Medical Center, Washington D.C.

21236

Chesapeake Clinical Research, Inc., Baltimore

21287

John Hopkins Hospital, Baltimore

27599

University of North Carolina at Chapel Hill, Clinical & Translational Research Center (CTRC), Chapel Hill

28007

Hospital General Universitario Gregorio Maranon, Madrid

28009

Hospital Infantil Universitario Nino Jesus, Madrid

28040

Hospital Clinico San Carlos, Madrid

28277

Clinical Research of Charlotte, Charlotte

29407

National Allergy and Asthma Research, LLC, Charleston

30060

Atlanta Allergy & Asthma Clinic, PA, Marietta

33613

University of South Florida Asthma, Allergy & Immunology Clinical Research Unit, Tampa

34239

Windom Allergy, Asthma and Sinus, Sarasota

35128

Az. Osp. - Univ. degli Studi- Padova, UOSD- Allergie Alimentari,, Padua

38105

LeBonheur Children's Hospital - Outpatient Building, Memphis

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

46032

IU North Riley Children's Specialists, Carmel

48109

University of Michigan Health System, Ann Arbor

55441

Clinical Research Institute Inc., Plymouth

60590

Universitatsklinikum Frankfurt, Klinik fur Kinger und Jagendmedizin, Frankfurt

60596

Medaimun GmbH, Frankfurt am Main

60611

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago

60637

Comer Children's Hospital, Chicago

61761

Sneeze, Wheeze & Itch Associates, LLC, Normal

64111

Children's Mercy on Broadway, Kansas City

68123

Asthma & Allergy Center, PC, Bellevue

72202

Arkansas Children's Hospital, Little Rock

75230

Allergy Partners of North Texas Research, Dallas

75235

Children's Medical Center, Dallas

77030

Texas Children's Hospital, Houston

78229

Sylvana Research, San Antonio

78723

Specially for Children Allergy, Asthma and Immunology Clinic, Austin

79903

Western Sky Medical Research, El Paso

80045

Children's Hospital Colorado, Aurora

80112

Colorado Allergy & Asthma Centers, P.C., Centennial

80206

National Jewish Health, Denver

83616

Idaho Allergy LLC dba Idaho Research, Eagle

85724

Banner University of Arizona Medical Center, Tucson

90274

Peninsula Research Associates, Inc., Rolling Hills Estates

90404

UCLA Medical Center, Santa Monica, Los Angeles

90806

Long Beach Memorial Medical Center / Miller Children's and Women's Hospital, Long Beach

92123

Allergy & Asthma Medical Group and Research Center, A.P.C, San Diego

Rady Children's Hospital, San Diego

92691

Allergy & Asthma Associates of Southern California dba Southern California Research, Mission Viejo

94040

Sean N. Parker Center for Allergy Research, LPCH at El Camino Hospital, Mountain View

94158

University of California, San Francisco, San Francisco

97223

Baker Allergy Asthma & Dermatology Research Center, LLC, Portland

98101

Virginia Mason Medical Center, Seattle

98115

Northwest Asthma and Allergy Center, Seattle

02114

Massachusetts General Hospital, Boston

02115

Boston Children's Hospital, Boston

07712

Atlantic Research Center, LLC, Ocean City

L8S 1G5

Ohayon, Hamilton

L5A 3V4

Cheema Research, Inc., Mississauga

K1G 6C6

Ottawa Allergy Research Corp, Ottawa

M4V 1R2

Gordon Sussman Clinical Research, Inc., Toronto

H4A3J1

Montreal Children's Hospital, Montreal

DK5000

Odense Universitetshospital - Department of Dermatology and Allergy Center, Odense

Unknown

Cork University Hospital, Cork

9713GZ

Universitair medisch Centrum Groningen, Groningen

University Medical Center Groningen, Groningen

118 83

Barnforskningscentrum, Sachs' Children and Youth Hospital, Stockholm

SE1 7EH

Guy and St Thomas' NHS Foundation Trust, London

M13 9WL

Central Manchester University Hospitals NHS Foundation Trust, Manchester

M23 9LT

University Hospital of South Manchester NHS Foundation Trust, Respiratory and Allergy Clinical Research Facility, Manchester

Sponsors
All Listed Sponsors
lead

Aimmune Therapeutics, Inc.

INDUSTRY

NCT02635776 - Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE) | Biotech Hunter | Biotech Hunter