A Phase 2 interventional study of AR201 powder and Placebo powder in Hen Egg Allergy, sponsored by Aimmune Therapeutics, Inc.. Terminated at 11 sites in United States. Open to participants aged 4 Years to 26 Years. Per ClinicalTrials.gov, last updated 2022-03-10.
Sponsored by Aimmune Therapeutics, Inc. · Phase 2, Interventional, and Treatment
To determine the efficacy and safety of AR201 in a characterized oral desensitization immunotherapy (CODIT™) regimen in hen egg-allergic subjects aged 4 to 26 years, inclusive.
This is a phase 2, randomized, double-blind, placebo-controlled study of the efficacy and safety of AR201 in a CODIT regimen in hen egg-allergic subjects aged 4 to 26 years, inclusive. The study was conducted at 8 sites in the United States.
1,055 studies on the registry are indexed under Hypersensitivity; 149 are open to participants now.
This study's enrollment of 15 is below the median of 73 across 691 interventional studies indexed under Hypersensitivity.
Browse Hypersensitivity studies →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.
Key Inclusion Criteria:
Key Exclusion Criteria:
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.
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.
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.
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.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects were randomized to active arm of AIME01 and administered AR201 in escalating doses for approximately 6 months, followed by a maintenance dose for approximately 12 weeks
Biological: AR201 powder
Subjects were randomized to placebo arm of AIME01 and administered placebo for approximately 6 months, followed by maintenance placebo for approximately 12 weeks.
Biological: Placebo powder
AR201 powder (Hen Egg allergen formulation) provided in capsules
Placebo powder provided in capsules
Proportion of Subjects Tolerating a Single Highest Dose of at Least 1000 mg Dried Egg White Protein With no More Than Mild Symptoms at the Exit Double-blind Placebo Controlled Food Challenge (DBPCFC)
Time frame: 9-12 months
Number of Participants by Maximum Dose Achieved With no or Mild Symptoms at Exit DBPCFC
Time frame: 9-12 months
| Milestone | AR201 Powder | Placebo Powder |
|---|---|---|
| Started | 9 | 6 |
| Completed | 6 | 3 |
| Not completed | 3 | 3 |
| Withdrew: Sponsor discontinued study | 3 | 3 |
| Participants | AR201 Powder | Placebo Powder |
|---|---|---|
| Proportion of Subjects Tolerating a Single Highest Dose of at Least 1000 mg Dried Egg White Protein With no More Than Mild Symptoms at the Exit Double-blind Placebo Controlled Food Challenge (DBPCFC) | 1 | 0 |
| Participants | AR201 Powder | Placebo Powder |
|---|---|---|
| None | 0 | 0 |
| 1 mg | 0 | 0 |
| 3 mg | 0 | 0 |
| 10 mg | 0 | 0 |
| 30 mg | 0 | 0 |
| 100 mg | 0 | 0 |
| 300 mg | 2 | 0 |
| 600 mg | 0 | 0 |
| 1000 mg | 0 | 0 |
| 2000 mg | 1 | 0 |
| Did not have an exit DBPCFC | 6 | 6 |
Collected over Approximately 9 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AR201 Powder | 0/9 (0%) | 1/9 (11.1%) | 9/9 (100%) |
| Placebo Powder | 0/6 (0%) | 0/6 (0%) | 5/6 (83.3%) |
| Event | AR201 Powder | Placebo Powder |
|---|---|---|
| Subdural haematomaInjury, poisoning and procedural complications | 1/9 | 0/6 |
| HeadacheNervous system disorders | 1/9 | 0/6 |
| Event | AR201 Powder | Placebo Powder |
|---|---|---|
| Abdominal painGastrointestinal disorders | 5/9 | 2/6 |
| Abdominal pain upperGastrointestinal disorders | 1/9 | 3/6 |
| PruritusSkin and subcutaneous tissue disorders | 3/9 | 3/6 |
| UrticariaSkin and subcutaneous tissue disorders | 4/9 | 2/6 |
| NauseaGastrointestinal disorders | 3/9 | 1/6 |
| Oral pruritusGastrointestinal disorders | 1/9 | 2/6 |
| Tongue pruritusGastrointestinal disorders | 1/9 | 2/6 |
| HeadacheNervous system disorders | 3/9 | 1/6 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 1/9 | 2/6 |
| VomitingGastrointestinal disorders | 2/9 | 1/6 |
| Age, Continuous(years) | AR201 Powder | Placebo Powder | Total |
|---|---|---|---|
| Median | 13.0 (6 to 23) | 5.5 (4 to 12) | 7.0 (4 to 23) |
| Sex: Female, Male(Participants) | AR201 Powder | Placebo Powder | Total |
|---|---|---|---|
| Female | 5 | 3 | 8 |
| Male | 4 | 3 | 7 |
| Ethnicity (NIH/OMB)(Participants) | AR201 Powder | Placebo Powder | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 8 | 6 | 14 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | AR201 Powder | Placebo Powder | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 7 | 4 | 11 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 2 | 2 |
| Region of Enrollment(participants) | AR201 Powder | Placebo Powder | Total |
|---|---|---|---|
| United States | 9 | 6 | 15 |
Plan to share: No
This study is terminated, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Aimmune Therapeutics, Inc.