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NCT03703791
Real World, Open Label, QOL Assessment of Peanut Immunotherapy AR101 in Children and Adolescents
Phase 3 trial testing AR101 in Peanut Allergy in 1 participant. Terminated before completion.
23 November 2018
Quick facts
| Lead sponsor | Aimmune Therapeutics, Inc. |
|---|---|
| Phase | Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1 |
| Start date | 24 October 2018 |
| Primary completion | 23 November 2018 |
| Estimated completion | 23 November 2018 |
| Sites | 11 locations across Spain |
Drugs / interventions tested
- AR101 — full drug profile →
Conditions studied
- Peanut Allergy — all drugs for Peanut Allergy →
Sponsor
Aimmune Therapeutics, Inc. — full company profile →
Who can join
Adults 4 to 17, any sex, with Peanut Allergy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To compare the HRQOL of AR101 characterized oral desensitization immunotherapy (CODIT™) in combination with standard of care (peanut avoidance, education) versus standard of care alone in peanut-allergic subjects aged 4 to 17 years.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03703791
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of AR101
Trials testing the same drug.
- NCT03682770 — Study in Pediatric Subjects With Peanut Allergy to Evaluate Efficacy and Safety of Dupilumab as Adjunct to AR101 (Peanut · Phase 2 · completed
- NCT03292484 — Longer-term Study of AR101 in Subjects Who Participated in a Prior AR101 Study (ARC008) · Phase 3 · completed
- NCT03337542 — AR101 Real-World Open-Label Extension Study · Phase 3 · completed
- NCT03126227 — Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children (RAMSES) · Phase 3 · completed
- NCT02993107 — PALISADE Follow-on Study (ARC004) · Phase 3 · completed
Other recruiting trials for Peanut Allergy
Currently open trials in the same condition.
- NCT07349212 — UKK-0018 as an Immunotherapeutic for Treatment of Peanut Allergies · Phase 1, PHASE2 · recruiting
- NCT05695261 — Evaluating the Safety and Efficacy of Oral Encapsulated Microbiota Transplantation Therapy in Peanut Allergic Patients · Phase 2 · recruiting
- NCT05503446 — Using Commonly Available Food Products To Treat Food Allergy · NA · active not recruiting
- NCT05667610 — Immune-supportive Diet and Gut Permeability in Allergic Children · NA · recruiting
- NCT06256146 — Investigating Modified Protocols of Oral Immunotherapy to Validate Efficacy and Safety · NA · recruiting
Other Aimmune Therapeutics, Inc. trials
Trials by the same sponsor.
- NCT04056299 — Oral Immunotherapy for Desensitization in Children, Adolescents, and Young Adults With Hen Egg Allergy · Phase 2 · terminated
- NCT03736447 — Peanut Oral Immunotherapy Study of Early Intervention for Desensitization · Phase 3 · completed
- NCT03292484 — Longer-term Study of AR101 in Subjects Who Participated in a Prior AR101 Study (ARC008) · Phase 3 · completed
- NCT03337542 — AR101 Real-World Open-Label Extension Study · Phase 3 · completed
- NCT03201003 — ARTEMIS Peanut Allergy In Children · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03703791 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Aimmune Therapeutics, Inc.
- Last refreshed: 13 July 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03703791.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing