A Phase 2 interventional study of AR101 powder provided in capsules and Placebo powder provided in capsules in Peanut Allergy, sponsored by Aimmune Therapeutics, Inc.. Completed at 8 sites in United States. Open to participants aged 4 Years to 26 Years. Per ClinicalTrials.gov, last updated 2021-11-30.
Sponsored by Aimmune Therapeutics, Inc. · Phase 2, Interventional, and Treatment
This is a multi-center, randomized, double-blind placebo controlled study of efficacy and safety of characterized peanut oral immunotherapy in peanut allergic individuals.
This is a multicenter, randomized, double-blind placebo controlled study of efficacy and safety of characterized peanut OIT in peanut allergic individuals. All eligible subjects will receive an escalating dose of CPNA or placebo. Approximately 50 subjects will be randomized 1:1 to peanut OIT or placebo.
166 studies on the registry are indexed under Peanut Hypersensitivity; 27 are open to participants now.
This study's enrollment of 56 is above the median of 50 across 127 interventional studies indexed under Peanut Hypersensitivity.
Browse Peanut 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.
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.
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.
Study product provided as peanut protein in pull-apart capsules
Biological: AR101 powder provided in capsules
Placebo formulation in pull-apart capsules containing only inactive ingredients
Biological: Placebo powder provided in capsules
Drug pages: Panobacumab · Iclaprim, (r)-
Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol
Study product formulated to contain only inactive ingredients for use as defined in the protocol
The Percentage of Subjects Who Tolerate at Least 300 mg (443 mg Cumulative) of Peanut Protein With no More Than Mild Symptoms at the Exit DBPCFC
The primary endpoint was the percentage of subjects who achieved desensitization, as determined by tolerating at least 300 mg (443 mg cumulative) of peanut protein at the Exit Double Blind Placebo Controlled Food Challenge (DBPCFC) with no more than mild symptoms (i.e., desensitization responders)
Time frame: 6-9 Months
Change From Baseline in Maximum Tolerated Dose of Peanut Protein at the Exit DBPCFC
The change in maximum tolerated dose of peanut protein from baseline (screening) to the Exit Double-Blind, Placebo-Controlled Food Challenge
Time frame: 6-9 months
Number of Participants by Maximum Dose Achieved With no or Mild Symptoms at Exit DBPCFC
Time frame: 6-9 months
Changes in Peanut-Specific IgE From Baseline to Exit DBPCFC
Time frame: 6-9 months
Changes in Peanut-Specific IgG4 From Baseline to Exit DBPCFC
Time frame: 6-9 months
Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter Results From Baseline
Time frame: Baseline, 6-9 months
| Milestone | AR101 Powder Provided in Capsules | Placebo Powder Provided in Capsules |
|---|---|---|
| Started | 29 | 27 |
| Completed | 23 | 26 |
| Not completed | 6 | 1 |
| Withdrew: Adverse event | 4 | 0 |
| Withdrew: Withdrawal by subject | 1 | 1 |
| Withdrew: Physician decision | 1 | 0 |
The primary endpoint was the percentage of subjects who achieved desensitization, as determined by tolerating at least 300 mg (443 mg cumulative) of peanut protein at the Exit Double Blind Placebo Controlled Food Challenge (DBPCFC) with no more than mild symptoms (i.e., desensitization responders)
| Participants | AR101 Powder Provided in Capsules | Placebo Powder Provided in Capsules |
|---|---|---|
| The Percentage of Subjects Who Tolerate at Least 300 mg (443 mg Cumulative) of Peanut Protein With no More Than Mild Symptoms at the Exit DBPCFC | 23 | 5 |
The change in maximum tolerated dose of peanut protein from baseline (screening) to the Exit Double-Blind, Placebo-Controlled Food Challenge
| Change from baseline in MTD (log10 mg) | AR101 Powder Provided in Capsules | Placebo Powder Provided in Capsules |
|---|---|---|
| Change From Baseline in Maximum Tolerated Dose of Peanut Protein at the Exit DBPCFC | 1.254 (0.984 to 1.523) | 0.341 (0.057 to 0.626) |
| Participants | AR101 Powder Provided in Capsules | Placebo Powder Provided in Capsules |
|---|---|---|
| 0.3 mg | 0 | 1 |
| 3 mg | 2 | 2 |
| 10 mg | 3 | 7 |
| 30 mg | 1 | 5 |
| 100 mg | 0 | 6 |
| 300 mg | 5 | 5 |
| 600 mg | 18 | 0 |
| kUA/L | AR101 Powder Provided in Capsules | Placebo Powder Provided in Capsules |
|---|---|---|
| Peanut-Specific IgE, Baseline | 32.571 (18.626 to 56.957) | 53.839 (34.952 to 82.934) |
| Peanut-Specific IgE, Exit | 36.889 (21.258 to 64.015) | 57.060 (37.186 to 87.557) |
| Relative Change From Baseline of Peanut-Specific IgGE | 1.231 (1.027 to 1.475) | 1.060 (1.001 to 1.122) |
| μg/mL | AR101 Powder Provided in Capsules | Placebo Powder Provided in Capsules |
|---|---|---|
| Peanut-Specific IgG4, Baseline | 0.734 (0.487 to 1.107) | 0.510 (0.344 to 0.757) |
| Peanut-Specific IgG4, Exit | 3.609 (2.074 to 6.281) | 0.540 (0.377 to 0.775) |
| Relative Change From Baseline of Peanut-Specific IgG4 | 5.068 (3.640 to 7.055) | 1.066 (0.905 to 1.255) |
| millimeter | AR101 Powder Provided in Capsules | Placebo Powder Provided in Capsules |
|---|---|---|
| Peanut Wheal, Baseline (mm) | 14.1 (11.6 to 16.7) | 13.7 (11.4 to 16.0) |
| Peanut Wheal, Exit (mm) | 7.1 (5.7 to 8.6) | 11.8 (9.3 to 14.4) |
| Change in Peanut Wheel from Baseline (mm) | -7.0 (-9.9 to -4.1) | -1.8 (-4.8 to -1.1) |
Collected over 6-9 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AR101 Powder Provided in Capsules | 0/29 (0%) | 1/29 (3.4%) | 28/29 (96.6%) |
| Placebo Powder Provided in Capsules | 0/26 (0%) | 1/26 (3.8%) | 22/26 (84.6%) |
| Event | AR101 Powder Provided in Capsules | Placebo Powder Provided in Capsules |
|---|---|---|
| HypersensitivityImmune system disorders | 1/29 | 1/26 |
| Event | AR101 Powder Provided in Capsules | Placebo Powder Provided in Capsules |
|---|---|---|
| HypersensitivityImmune system disorders | 26/29 | 14/26 |
| Upper Respiratory Tract InfectionInfections and infestations | 2/29 | 5/26 |
| PyrexiaGeneral disorders | 5/29 | 4/26 |
| VomitingGastrointestinal disorders | 4/29 | 2/26 |
| DiarrhoeaGastrointestinal disorders | 1/29 | 3/26 |
| Nasal congestionRespiratory, thoracic and mediastinal disorders | 2/29 | 3/26 |
| HeadacheNervous system disorders | 3/29 | 3/26 |
| Viral InfectionInfections and infestations | 3/29 | 1/26 |
| NauseaGastrointestinal disorders | 3/29 | 1/26 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 3/29 | 1/26 |
These values reflect the intent-to-treat population (subjects who received at least 1 dose of randomized study treatment)
| Age, Continuous(years) | AR101 Powder Provided in Capsules | Placebo Powder Provided in Capsules | Total |
|---|---|---|---|
| Median | 7.0 (4 to 21) | 8.0 (4 to 14) | 8.0 (4 to 21) |
| Sex: Female, Male(Participants) | AR101 Powder Provided in Capsules | Placebo Powder Provided in Capsules | Total |
|---|---|---|---|
| Female | 9 | 10 | 19 |
| Male | 20 | 16 | 36 |
| Ethnicity (NIH/OMB)(Participants) | AR101 Powder Provided in Capsules | Placebo Powder Provided in Capsules | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 29 | 26 | 55 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | AR101 Powder Provided in Capsules | Placebo Powder Provided in Capsules | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 2 | 3 |
| White | 26 | 20 | 46 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 2 | 3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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Studies of the drugs tested here: Panobacumab · Iclaprim, (r)-
Aimmune Therapeutics, Inc.