AR101 Real-World Open-Label Extension Study
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03337542 |
Recruitment Status :
Active, not recruiting
First Posted : November 9, 2017
Last Update Posted : December 20, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Peanut Allergy | Biological: AR101 | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 330 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children, Active Treatment Arm Open-Label Extension Study (RAMSES OLE) |
Actual Study Start Date : | October 19, 2017 |
Estimated Primary Completion Date : | February 2019 |
Estimated Study Completion Date : | April 2019 |
Arm | Intervention/treatment |
---|---|
Treatment arm description
Subjects will receive maintenance dosing with AR101.
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Biological: AR101
AR101 |
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: 6 months ]Incidence and frequency of treatment-emergent adverse events including serious adverse events during the overall study period (Safety and Tolerability)

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Ages Eligible for Study: | 4 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
- Received AR101 in study ARC007
- Completed the ARC007 study
- Use of effective birth control by sexually active female subjects of childbearing potential
Key Exclusion Criteria:
- Developed a clinically significant change in health status during the ARC007 study which in the opinion of the investigator would make the subject unsuitable for participation in this study.
- Receiving a prohibited medication or anticipated use of a prohibited medication [e.g., angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers or calcium channel blockers], any monoclonal antibody, any investigational peanut immunotherapy, or any other immunomodulatory therapy.
- Currently in the build-up phase of immunotherapy for any nonfood allergen.
- Currently participating in any other interventional clinical study outside of the ARC007 study that was just completed.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03337542

Study Chair: | Freddy Byrth | Director, Clinical Operations |
Additional Information:
Responsible Party: | Aimmune Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT03337542 History of Changes |
Other Study ID Numbers: |
ARC011 |
First Posted: | November 9, 2017 Key Record Dates |
Last Update Posted: | December 20, 2018 |
Last Verified: | December 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | Yes | |
Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Aimmune Therapeutics, Inc.:
AR101 Characterized Peanut Allergen CPNA (Characterized Peanut Allergen) OIT (oral immunotherapy) |
Peanut Allergy Peanut-Allergic Children Desensitization Food Allergy |
Additional relevant MeSH terms:
Hypersensitivity Peanut Hypersensitivity Immune System Diseases Food Hypersensitivity Hypersensitivity, Immediate |