CompletedNCT02993107Updated Mar 17, 2022Results posted

PALISADE Follow-on Study (ARC004)

A Phase 3 interventional study of AR101 in Peanut Allergy, sponsored by Aimmune Therapeutics, Inc.. Completed at 65 sites in 9 countries. Open to participants aged 4 Years to 55 Years. Per ClinicalTrials.gov, last updated 2022-03-17.

Sponsored by Aimmune Therapeutics, Inc. · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 388
Allocation: Randomized
Ages: 4 Years to 55 Years
Sex: All

Study summary

The purpose of this study is to demonstrate the safety, tolerability, and efficacy of AR101 through oral immunotherapy (OIT) in peanut-allergic children and adults who have completed the ARC003 study.

Read the detailed description

This is an international, multicenter, open-label, 2-arm follow-on study of the safety, tolerability, and efficacy of AR101 in peanut-allergic individuals who have completed the ARC003 study. This study will explore alternative dosing regimens during extended maintenance with AR101.

Conditions studied

Peanut Allergy

Browse trials for

Keywords

AR101
Characterized Peanut Allergen
CPNA (Characterized Peanut Allergen)
OIT (oral immunotherapy)
Peanut Allergy
Allergy
Peanut-Allergic Children
Peanut-Allergic Adults
Desensitization
PALISADE

In context

Peanut Hypersensitivity

166 studies on the registry are indexed under Peanut Hypersensitivity; 27 are open to participants now.

This study's enrollment of 388 is above the median of 50 across 127 interventional studies indexed under Peanut Hypersensitivity.

Browse Peanut Hypersensitivity studies →

Lead sponsor

Aimmune Therapeutics, Inc. is the lead sponsor of 12 studies on the registry; none are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 11 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 4 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Key Inclusion Criteria:

Completion of the ARC003 study
Written and/or assent from subjects/guardians as appropriate
Use of effective by sexually active female subjects of

Key Exclusion Criteria:

Early discontinuation from the ARC003 study
Meets any longitudinally applicable ARC003 study exclusion criteria
(Group 2 only) Failure to tolerate ≥ 443 mg cumulative of peanut protein with no or mild symptoms in the ARC003 study Exit DBPCFC
Any other condition that, in the opinion of the Investigator, precludes participation for reasons of safety

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 388 participants (actual)

Study arms

Other
Group 1 (Placebo Crossovers)
Subjects who complete the placebo arm of ARC003 and consent to enroll in ARC004 (Group-1) will cross over to active treatment with AR101 using the same dosing regimen used in ARC003 in open-label fashion. Group 1 subjects may also be assigned to cohorts which test the gradual lengthening of dosing intervals. Following the completion of their longest tested dosing interval, Group 1 subjects will undergo an exit double-blinded placebo-controlled food challenge (DBPCFC).
Biological: AR101
Other
Group 2 (Active Rollovers)
Subjects who successfully complete the active arm of ARC003 and consent to enroll in ARC004 (Group-2) will consecutively enter treatment with AR101 in one of three cohorts which will test alternate dosing intervals. There will be a DBPCFC at the completion of the subject's longest tested dosing interval.
Biological: AR101

Interventions

BiologicalAR101
Drug pages: Panobacumab · Iclaprim, (r)-
AR101 powder provided in capsules \& sachets

What researchers measure

Primary outcomes

Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE)
Percentage of subjects ages 4-17 with at-least 1 TEAE, including serious adverse events, during the overall study period. The percentage of subjects reporting at least 1 TEAE by maximum reported severity is also presented using the 5-point CTCAE severity grading scale. All safety evaluations were conducted using the safety population (all subjects who received at least 1 dose of AR101 during ARC004), age 4-17 years. Safety data are presented for group 1 (former placebo) and Group 2 data are divided into columns for cohort 1 (QD), cohort 2 (overall), cohort 3A (QD), and cohorts 3B and 3C (overall).
Time frame: Up to 126 weeks

Secondary outcomes

Percentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge)
The percentage of subjects who tolerated each the of 300 mg, 600 mg, 1000 mg, or 2000 mg challenge doses with no more than mild symptoms at exit DBPCFC. Analyses based on DBPCFCs used the completer population (age 4-17 years).
Time frame: Up to 126 weeks

Results

Posted Dec 15, 2021

Participant flow

Participant flow — Overall Study
Milestone	Group 1 (Placebo Crossovers)	Group 2: Cohort 1 (Active Rollovers)	Group 2: Cohort 2 (Active Rollovers)	Group 2: Cohort 3A (Active Rollovers)	Group 2: Cohort 3B (Active Rollovers)	Group 2: Cohort 3C (Active Rollovers)
Started	113	120	50	35	34	36
Adverse event	12	4	1	1	3	5
Physician decision	1	0	1	0	0	0
Withdrawal by subject	32	7	7	3	6	2
Lost to follow-up	0	1	0	0	0	1
Sponsor decision	4	0	1	1	0	4
Protocol deviation	0	0	0	0	1	0
Other reasons	2	1	1	1	2	3
Completed	62	107	39	29	22	21
Not completed	51	13	11	6	12	15

Outcome measures

PrimaryPercentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE)

Percentage of subjects ages 4-17 with at-least 1 TEAE, including serious adverse events, during the overall study period. The percentage of subjects reporting at least 1 TEAE by maximum reported severity is also presented using the 5-point CTCAE severity grading scale. All safety evaluations were conducted using the safety population (all subjects who received at least 1 dose of AR101 during ARC004), age 4-17 years. Safety data are presented for group 1 (former placebo) and Group 2 data are divided into columns for cohort 1 (QD), cohort 2 (overall), cohort 3A (QD), and cohorts 3B and 3C (overall).

Time frame:: Up to 126 weeks
Reported as:: Count of participants · Participants

Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE)
Participants	Group 1 (Overall)	Group 2: Cohort 1 (QD)	Group 2: Cohort 2 (Overall)	Group 2: Cohort 3A (QD)	Group 2: Cohort 3B (Overall)	Group 2: Cohort 3C (Overall)
All AEs	98	90	36	27	28	33
SAEs	0	1	0	0	1	1
Grade 1: Mild	37	58	22	15	13	12
Grade 2: Moderate	58	29	14	12	15	18
Grade 3: Severe	3	3	0	0	0	3
Grade 4: Life-Threatening	0	0	0	0	0	0
Grade 5: Death	0	0	0	0	0	0

SecondaryPercentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge)

The percentage of subjects who tolerated each the of 300 mg, 600 mg, 1000 mg, or 2000 mg challenge doses with no more than mild symptoms at exit DBPCFC. Analyses based on DBPCFCs used the completer population (age 4-17 years).

Time frame:: Up to 126 weeks
Reported as:: Number · Percent of participants

Percentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge)
Percent of participants	Group 1 (Placebo Crossovers)	Group 2: Cohort 1 (Active Rollovers)	Group 2: Cohort 2 (Active Rollovers)	Group 2: Cohort 3A (Active Rollovers)	Group 2: Cohort 3B (Active Rollovers)	Group 2: Cohort 3C (Active Rollovers)
Percentage (and 95% CI) tolerating 300 mg	98.6 (92.5 to 100)	98.1 (93.2 to 99.8)	94.7 (82.3 to 99.4)	100.0 (86.8 to 100.0)	81.8 (59.7 to 94.8)	90.5 (69.6 to 98.8)
Percentage (and 95% CI) tolerating 600 mg	86.1 (75.9 to 93.1)	89.3 (81.7 to 94.5)	71.1 (54.1 to 84.6)	96.2 (80.4 to 99.9)	77.3 (54.6 to 92.2)	76.2 (52.8 to 91.8)
Percentage (and 95% CI) tolerating 1000 mg	72.2 (60.4 to 82.1)	80.6 (71.6 to 87.7)	57.9 (40.8 to 73.7)	96.2 (80.4 to 99.99)	68.2 (45.1 to 86.1)	66.7 (43.0 to 85.4)
Percentage (and 95% CI) tolerating 2000 mg	51.4 (39.3 to 63.3)	48.5 (38.6 to 58.6)	36.8 (21.8 to 54.0)	80.8 (60.6 to 93.4)	45.5 (24.4 to 67.8)	42.9 (21.8 to 66.0)

Adverse events

Collected over 28 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Group 1 (Age 4-17 Overall)	0/100 (0%)	0/100 (0%)	98/100 (98%)
Group 2: Cohort 1 (Age 4-17 QD)	0/109 (0%)	1/109 (0.9%)	90/109 (82.6%)
Group 2: Cohort 2 (Age 4-17 Overall)	0/46 (0%)	0/46 (0%)	36/46 (78.3%)
Group 2: Cohort 3A (Age 4-17 QD)	0/31 (0%)	0/31 (0%)	27/31 (87.1%)
Group 2: Cohort 3B (Age 4-17 Overall)	0/31 (0%)	1/31 (3.2%)	28/31 (90.3%)
Group 2: Cohort 3C (Age 4-17 Overall)	0/34 (0%)	1/34 (2.9%)	33/34 (97.1%)
Group 1 (Age 18-55 Overall)	0/11 (0%)	0/11 (0%)	10/11 (90.9%)
Group 2: Cohort 1 (Age 18-55 QD)	0/8 (0%)	1/8 (12.5%)	6/8 (75%)
Group 2: Cohort 2 (Age 18-55 Overall)	0/2 (0%)	0/2 (0%)	1/2 (50%)
Group 2: Cohort 3A (Age 18-55 QD)	0/4 (0%)	0/4 (0%)	2/4 (50%)
Group 2: Cohort 3B (Age 18-55 Overall)	0/3 (0%)	0/3 (0%)	2/3 (66.7%)
Group 2: Cohort 3C (Age 18-55 Overall)	0/2 (0%)	0/2 (0%)	2/2 (100%)

Most frequent serious events

Most frequent serious events
Event	Group 1 (Age 4-17 Overall)	Group 2: Cohort 1 (Age 4-17 QD)	Group 2: Cohort 2 (Age 4-17 Overall)	Group 2: Cohort 3A (Age 4-17 QD)	Group 2: Cohort 3B (Age 4-17 Overall)	Group 2: Cohort 3C (Age 4-17 Overall)	Group 1 (Age 18-55 Overall)	Group 2: Cohort 1 (Age 18-55 QD)	Group 2: Cohort 2 (Age 18-55 Overall)	Group 2: Cohort 3A (Age 18-55 QD)	Group 2: Cohort 3B (Age 18-55 Overall)	Group 2: Cohort 3C (Age 18-55 Overall)
Intestinal perforationGastrointestinal disorders	0/100	0/109	0/46	0/31	0/31	0/34	0/11	1/8	0/2	0/4	0/3	0/2
Abdominal painGastrointestinal disorders	0/100	0/109	0/46	0/31	1/31	0/34	0/11	0/8	0/2	0/4	0/3	0/2
Humerus fractureInjury, poisoning and procedural complications	0/100	0/109	0/46	0/31	0/31	1/34	0/11	0/8	0/2	0/4	0/3	0/2
Streptococcal infectionInfections and infestations	0/100	1/109	0/46	0/31	0/31	0/34	0/11	0/8	0/2	0/4	0/3	0/2
DehydrationMetabolism and nutrition disorders	0/100	1/109	0/46	0/31	0/31	0/34	0/11	0/8	0/2	0/4	0/3	0/2

Most frequent other events

Showing 10 of 112

Most frequent other events
Event	Group 1 (Age 4-17 Overall)	Group 2: Cohort 1 (Age 4-17 QD)	Group 2: Cohort 2 (Age 4-17 Overall)	Group 2: Cohort 3A (Age 4-17 QD)	Group 2: Cohort 3B (Age 4-17 Overall)	Group 2: Cohort 3C (Age 4-17 Overall)	Group 1 (Age 18-55 Overall)	Group 2: Cohort 1 (Age 18-55 QD)	Group 2: Cohort 2 (Age 18-55 Overall)	Group 2: Cohort 3A (Age 18-55 QD)	Group 2: Cohort 3B (Age 18-55 Overall)	Group 2: Cohort 3C (Age 18-55 Overall)
HeadacheNervous system disorders	27/100	12/109	12/46	8/31	5/31	14/34	1/11	1/8	0/2	1/4	0/3	2/2
Throat irritationRespiratory, thoracic and mediastinal disorders	32/100	15/109	9/46	5/31	5/31	9/34	7/11	0/8	0/2	0/4	1/3	0/2
Abdominal pain upperGastrointestinal disorders	31/100	9/109	6/46	5/31	6/31	4/34	6/11	0/8	0/2	1/4	0/3	0/2
NauseaGastrointestinal disorders	33/100	9/109	9/46	5/31	5/31	5/34	6/11	0/8	1/2	1/4	1/3	0/2
RhinorrhoeaRespiratory, thoracic and mediastinal disorders	28/100	7/109	2/46	3/31	4/31	7/34	6/11	0/8	0/2	1/4	0/3	0/2
Eye pruritusEye disorders	8/100	5/109	4/46	1/31	3/31	6/34	2/11	0/8	0/2	0/4	0/3	1/2
Abdominal painGastrointestinal disorders	38/100	11/109	7/46	5/31	7/31	16/34	5/11	0/8	1/2	0/4	0/3	0/2
Paraesthesia oralGastrointestinal disorders	6/100	0/109	2/46	2/31	2/31	4/34	3/11	0/8	1/2	0/4	0/3	0/2
NasopharyngitisInfections and infestations	16/100	5/109	5/46	5/31	5/31	9/34	3/11	0/8	0/2	1/4	0/3	1/2
Upper respiratory tract infectionInfections and infestations	23/100	20/109	6/46	3/31	5/31	7/34	5/11	4/8	0/2	0/4	1/3	0/2

Baseline characteristics

A total of 388 subjects were enrolled. However, only 381 received any amount of treatment and were included in the Safety population, which includes all subjects who received at least one dose of open-label study treatment in any cohort.

Age, Customized
Age, Customized(Participants)	Group 1 (Placebo Crossovers)	Group 2: Cohort 1 (Active Rollovers)	Group 2: Cohort 2 (Active Rollovers)	Group 2: Cohort 3A (Active Rollovers)	Group 2: Cohort 3B (Active Rollovers)	Group 2: Cohort 3C (Active Rollovers)	Total
Age 18-55 years	11	8	2	4	3	2	30
Age 4-17 years	100	109	46	31	31	34	351

Sex: Female, Male
Sex: Female, Male(Participants)	Group 1 (Placebo Crossovers)	Group 2: Cohort 1 (Active Rollovers)	Group 2: Cohort 2 (Active Rollovers)	Group 2: Cohort 3A (Active Rollovers)	Group 2: Cohort 3B (Active Rollovers)	Group 2: Cohort 3C (Active Rollovers)	Total
Female	39	55	22	16	13	17	162
Male	72	62	26	19	21	19	219

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Group 1 (Placebo Crossovers)	Group 2: Cohort 1 (Active Rollovers)	Group 2: Cohort 2 (Active Rollovers)	Group 2: Cohort 3A (Active Rollovers)	Group 2: Cohort 3B (Active Rollovers)	Group 2: Cohort 3C (Active Rollovers)	Total
Hispanic or Latino	13	9	3	4	1	1	31
Not Hispanic or Latino	98	108	45	31	33	35	350
Unknown or Not Reported	0	0	0	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Group 1 (Placebo Crossovers)	Group 2: Cohort 1 (Active Rollovers)	Group 2: Cohort 2 (Active Rollovers)	Group 2: Cohort 3A (Active Rollovers)	Group 2: Cohort 3B (Active Rollovers)	Group 2: Cohort 3C (Active Rollovers)	Total
American Indian or Alaska Native	0	0	0	0	1	0	1
Asian	7	14	7	3	1	3	35
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	1	1
Black or African American	3	3	1	0	0	0	7
White	86	92	33	28	30	28	297
More than one race	0	0	0	0	0	0	0
Unknown or Not Reported	15	8	7	4	2	4	40

Study locations

65 sites

Banner University of Arizona Medical Center
Tucson, Arizona 85724, United States
Arkansas Children's Hospital
Little Rock, Arkansas 72202, United States
Allergy & Asthma Associates of Southern California
Mission Viejo, California 92691, United States
Sean N. Parker Center for Allergy Research at Stanford University Packard-El Camino Hospital
Mountain View, California 94040, United States
Peninsula Research Associates, Inc.
Rolling Hills Estates, California 90274, United States
Allergy & Asthma Medical Group and Research Center, APC
San Diego, California 92123, United States
Rady Children's Hospital, San Diego
San Diego, California 92123, United States
University of California, San Francisco
San Francisco, California 94158, United States
UCLA Medical Center, Santa Monica
Santa Monica, California 90404, United States
Children's Hospital Colorado
Aurora, Colorado 80045, United States
Colorado Allergy & Asthma Centers, P.C.
Centennial, Colorado 80122, United States
National Jewish Health
Denver, Colorado 80206, United States
Children's National Medical Center
Washington, District of Columbia 20010, United States
Sarasota Clinical Research
Sarasota, Florida 34239, United States
University of South Florida Asthma, Allergy, and Immunology Clinical Research Unit
Tampa, Florida 33613, United States
Atlanta Allergy & Asthma Clinic, PA
Marietta, Georgia 30060, United States
Idaho Allergy and Research, dba Idaho Research
Eagle, Idaho 83616, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois 60611, United States
Comer Children's Hospital
Chicago, Illinois 60637, United States
Sneeze, Wheeze, & Itch Associates, LLC
Normal, Illinois 61761, United States
IU North Riley Children's Specialist
Carmel, Indiana 46032, United States
Chesapeake Clinical Research, Inc.
Baltimore, Maryland 21236, United States
Johns Hopkins Hospital
Baltimore, Maryland 21287, United States
Massachusetts General Hospital
Boston, Massachusetts 02114, United States
Boston Children's Hospital, Div. of Allergy & Immunology
Boston, Massachusetts 02115, United States
Michigan Medicine, Michigan Clinical Research Unit
Ann Arbor, Michigan 48109, United States
Clinical Research Institute, Inc.
Plymouth, Minnesota 55441, United States
Children's Mercy on Broadway
Kansas City, Missouri 64111, United States
Nebraska Medical Research Institute Inc.
Bellevue, Nebraska 68123, United States
Atlantic Research Center, LLC
Ocean City, New Jersey 07712, United States
Icahn School of Medicine at Mount Sinai, Clinical Research Unit
New York, New York 10029, United States
University of North Carolina at Chapel Hill, Clinical & Translational Research Center (CTRC)
Chapel Hill, North Carolina 27599, United States
Clinical Research of Charlotte
Charlotte, North Carolina 28277, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229, United States
Baker Allergy, Asthma & Dermatology
Portland, Oregon 97223, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania 15224, United States
National Allergy and Asthma Research, LLC
Charleston, South Carolina 29407, United States
Le Bonheur Children's Hospital - Outpatient Building
Memphis, Tennessee 38105, United States
'Specially for Children Allergy, Asthma and Immunology Clinic
Austin, Texas 78723, United States
Children's Health
Dallas, Texas 75235, United States
Western Sky Medical Research
El Paso, Texas 79903, United States
Texas Children's Hospital, Baylor College of Medicine
Houston, Texas 77030, United States
Central Texas Health Research
New Braunfels, Texas 78130, United States
Sylvana Research Associates
San Antonio, Texas 78229, United States
Benaroya Research Inst. at Virginia Mason; Virginia Mason Medical Center
Seattle, Washington 98101, United States
Asthma Inc Clinical Research Center
Seattle, Washington 98115, United States
Triple A Lab
Hamilton, Ontario L8S 1G5, Canada
Cheema Research Inc.
Mississauga, Ontario L5A 3V4, Canada
Ottawa Allergy Research Corp
Ottawa, Ontario K1G 6C6, Canada
Gordon Sussman Clinical Research, Inc.
Toronto, Ontario M4V 1R2, Canada
Montreal Children's Hospital
Montréal, Quebec H4A 3J1, Canada
Charité Universitaetsmedizin Berlin
Berlin, 13353, Germany
University of Frankfurt
Frankfurt am Main, 60590, Germany
Cork University Hospital
Cork, T12 DC4A, Ireland
Azienda Ospedaliera di Padova
Padova, 35128, Italy
Beatrix Children's Hospital, University Medical Center Groningen
Groningen, 9700 RB, Netherlands
University Medical Center Groningen
Groningen, 9713 GZ, Netherlands
Hospital Gregorio Marañón
Madrid, 28007, Spain
H. Infantil Universitario Niño Jesús
Madrid, 28009, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Sachsska Children and Youth Hospital
Stockholm, 118 83, Sweden
Guy & St Thomas' NHS foundation Trust
London, SE1 7EH, United Kingdom
Central Manchester University Hospitals, NHS Foundation Trust
Manchester, M13 9WL, United Kingdom
Central Manchester University Hospitals, NHS Foundation Trust
Manchester, M23 9LT, United Kingdom

References and documents

Publications

Nilsson C, Scurlock AM, Dellon ES, Brostoff JM, Pham T, Ryan R, Brown KR, Adelman DC, Aceves SS. Onset of eosinophilic esophagitis during a clinical trial program of oral immunotherapy for peanut allergy. J Allergy Clin Immunol Pract. 2021 Dec;9(12):4496-4501. doi: 10.1016/j.jaip.2021.07.048. Epub 2021 Aug 11. No abstract available. PubMed 34389504 ↗

Study documents

Study protocol ↗ · Apr 12, 2018
Statistical analysis plan ↗ · Jul 10, 2019

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 17, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02993107
Lead sponsor: Aimmune Therapeutics, Inc.
Responsible party: Sponsor
First posted: Dec 15, 2016
Start date: Dec 29, 2016
Primary completion: May 31, 2019
Completion: May 31, 2019
Results posted: Dec 15, 2021
Last update: Mar 17, 2022

Study contacts

Director of Regulatory Affairs

study director · Aimmune Regulatory Affairs

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Panobacumab · Iclaprim, (r)-

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