10 completed, 2 terminated, 1 recruiting. 8 Phase 3, 4 Phase 2, 1 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 8 | Completed 7, Terminated 1 |
| Phase 2 | 4 | Completed 3, Terminated 1 |
| Not applicable | 1 | Recruiting 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Aimmune Longitudinal Collaboration Study Chia seeds - Stool Spore Colony Forming Units, Microbiome Composition | Not applicable | Recruiting | Aimmune Therapeutics, Inc. | 60 | 2025-10-01 | 2025-10-20 |
| Oral Immunotherapy for Desensitization in Children, Adolescents, and Young Adults With Hen Egg Allergy AR201 powder, Placebo powder - Hen Egg Allergy | Phase 2 | Terminated | Aimmune Therapeutics, Inc. | 15 | 2019-08-20 | 2022-03-10 |
| Peanut Oral Immunotherapy Study of Early Intervention for Desensitization AR101 powder provided in capsules & sachets, Placebo powder provided in capsules & sachets - Peanut Allergy | Phase 3 | Completed | Aimmune Therapeutics, Inc. | 146 | 2018-12-27 | 2023-03-02 |
| Real World, Open Label, QOL Assessment of Peanut Immunotherapy AR101 in Children and Adolescents AR101 - Peanut Allergy | Phase 3 | Terminated | Aimmune Therapeutics, Inc. | 1 | 2018-10-24 | 2021-07-13 |
| Study in Pediatric Subjects With Peanut Allergy to Evaluate Efficacy and Safety of Dupilumab as Adjunct to AR101 (Peanut Oral Immunotherapy) Dupilumab, Placebo matching dupilumab, AR101 - Peanut Allergy | Phase 2 | Completed | Regeneron Pharmaceuticals | 148 | 2018-10-03 | 2024-02-07 |
| Longer-term Study of AR101 in Subjects Who Participated in a Prior AR101 Study (ARC008) AR101 - Peanut Allergy | Phase 3 | Completed | Aimmune Therapeutics, Inc. | 911 | 2017-11-02 | 2024-12-19 |
| AR101 Real-World Open-Label Extension Study AR101 - Peanut Allergy | Phase 3 | Completed | Aimmune Therapeutics, Inc. | 243 | 2017-10-18 | 2021-11-02 |
| ARTEMIS Peanut Allergy In Children AR101 powder provided in capsules & sachets, Placebo powder provided in capsules & sachets - Peanut Allergy | Phase 3 | Completed | Aimmune Therapeutics, Inc. | 175 | 2017-06-12 | 2021-08-03 |
| Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children (RAMSES) AR101, Placebo - Peanut Allergy | Phase 3 | Completed | Aimmune Therapeutics, Inc. | 506 | 2017-05-08 | 2021-11-02 |
| PALISADE Follow-on Study (ARC004) AR101 - Peanut Allergy | Phase 3 | Completed | Aimmune Therapeutics, Inc. | 388 | 2016-12-29 | 2022-03-17 |
| Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE) AR101 powder provided in capsules & sachets, Placebo powder provided in capsules & sachets - Peanut Allergy | Phase 3 | Completed | Aimmune Therapeutics, Inc. | 555 | 2015-12-22 | 2022-03-17 |
| Oral Desensitization to Peanut in Peanut Allergic Children and Adults Using CPNA Peanut OIT Safety Follow-On Study AR101 - Peanut protein capsule - Peanut Allergy | Phase 2 | Completed | Aimmune Therapeutics, Inc. | 47 | 2014-08-27 | 2021-11-09 |
| Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen OIT AR101 powder provided in capsules, Placebo powder provided in capsules - Peanut Allergy | Phase 2 | Completed | Aimmune Therapeutics, Inc. | 56 | 2014-02-06 | 2021-11-30 |
Peanut Hypersensitivity (11) · Hypersensitivity (8) · Food Hypersensitivity (2) · Severe combined immunodeficiency with sensitivity to ionizing radiation (1)
United States (11) · Canada (5) · Germany (5) · Spain (5) · United Kingdom (5) · Ireland (4) · Italy (4) · Sweden (4) · France (3) · Netherlands (3) · Denmark (1)
Jason Goldsmith, MD, PhD (1) · Jen Garcia (1)
PMID 34389504, PMID 34320250, PMID 36915184, PMID 30449234, PMID 32702315, PMID 38282192, PMID 38320526, PMID 38814736
2018 (1)