A Phase 3 interventional study of AR101 in Peanut Allergy, sponsored by Aimmune Therapeutics, Inc.. Completed at 60 sites in 2 countries. Open to participants aged 4 Years to 17 Years. Per ClinicalTrials.gov, last updated 2021-11-02.
Sponsored by Aimmune Therapeutics, Inc. · Phase 3, Interventional, and Treatment
This study is enrolling participants by invitation only. This is an open-label, safety extension study for subjects who participated in the ARC007 study.
This is a Phase 3, multi-center, North American, open-label, long-term, safety extension study for eligible subjects who received AR101 therapy in the ARC007 trial (NCT03126227) and completed the study.
166 studies on the registry are indexed under Peanut Hypersensitivity; 27 are open to participants now.
This study's enrollment of 243 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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will receive maintenance dosing with AR101. Maintenance doses are provided in sachets, where each sachet contains 300 mg of peanut protein. Subjects are to ingest 300 mg orally once a day during maintenance.
Biological: AR101
Drug pages: Panobacumab · Iclaprim, (r)-
AR101
Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability)
Number of participants with treatment-emergent adverse events including serious adverse events during the overall study period (safety and tolerability)
Time frame: Approximately 6 months
Number of Participants With Premature Discontinuation of Dosing Due to Adverse Events
Time frame: Approximately 6 months
Number of Participants With Early Discontinuation of Dosing Due to Chronic/Recurrent GI Adverse Events
Time frame: Approximately 6 months
Percentage of Subjects With Chronic/Recurrent GI Adverse Events Resolving Before 2, Between 2 and 4, Between 4 and 12, and ≥ 12 Weeks After Discontinuation of Dosing
Time frame: Approximately 6 months
Number of Participants With Allergic Hypersensitivity Adverse Events
Time frame: Approximately 6 months
Number of Participants With of Anaphylaxis as Defined in the Protocol
Anaphylaxis is likely when any 1 of the 3 following sets of criteria is fulfilled: 1. Acute onset of an illness (minutes to hours) with involvement of: (a) Skin/mucosal tissue (eg, generalized hives, itch/flush, swollen lips/tongue/uvula); AND (b) Airway compromise (eg, dyspnea, stridor, wheeze/bronchospasm, hypoxia, reduced PEFR); AND/OR (c) Reduced BP or associated symptoms (eg, hypotonia, syncope, incontinence). 2. Two or more of the following that occur rapidly after exposure to the allergen (minutes to hours): (a) Skin/mucosal tissue; (b) Airway compromise; (c) Reduced BP or associated symptoms; (d) Persistent GI symptoms (eg, nausea, vomiting, crampy abdominal pain). 3. Reduced BP after exposure to the allergen (minutes to hours). Infants and children: low systolic BP (age-specific) or \> 30% drop in systolic BP; Adults: systolic BP \< 90 mm Hg or \> 30% drop from their baseline.
Time frame: Approximately 6 months
Number of Participants With Epinephrine Use as Rescue Medication
Time frame: Approximately 6 months
Number of Participants With Accidental/Nonaccidental Ingestion of Peanut and Other Allergenic Foods
Number of participants with accidental/nonaccidental ingestion of peanut (not AR101 or food challenge material) and other allergenic foods.
Time frame: Approximately 6 months
Assessment of Asthma Control Using the Childhood Asthma Control Test (C-ACT) Questionnaire Total Score From Baseline, Every 4 Weeks, Early Discontinuation and Study Exit, Ages 4-11
The C-ACT for subjects aged 4 to 11 years included 4 questions for the subject and 3 questions for the parent/caregiver; the total score (sum of 7 questions) ranged from 0 (worst control) to 27 (total control).
Time frame: Baseline, Maintenance Visit 1 (Wk 4), Maintenance Visit 2 (Wk 8), Maintenance Visit 3 (Wk 12), Maintenance Visit 4 (Wk 16), Maintenance Visit 5 (Wk 20), Maintenance Visit 6 (Wk 24), Early Discontinuation (14 days after last dose), Study Exit (~6 months)
Assessment of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline, Every 4 Weeks, Early Discontinuation and Study Exit, Ages 12-17
The ACT for subjects aged 12 to 17 years consisted of 5 questions, and the total score (sum of 5 questions) ranged from 5 (worst control) to 25 (total control).
Time frame: Baseline, Maintenance Visit 1 (Wk 4), Maintenance Visit 2 (Wk 8), Maintenance Visit 3 (Wk 12), Maintenance Visit 4 (Wk 16), Maintenance Visit 5 (Wk 20), Maintenance Visit 6 (Wk 24), Early Discontinuation (14 days after last dose), Study Exit (~6 months)
Number of Participants With Adverse Events That Led to Early Withdrawal
Time frame: Approximately 6 months
| Milestone | AR101 |
|---|---|
| Started | 243 |
| Safety population | 242 |
| Completed | 222 |
| Not completed | 21 |
| Withdrew: Withdrew consent | 17 |
| Withdrew: Allergic adverse event | 1 |
| Withdrew: Chronic /recurrent gi adverse event/symptoms | 1 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Unable to participate in study due to relocation | 1 |
Number of participants with treatment-emergent adverse events including serious adverse events during the overall study period (safety and tolerability)
| Participants | AR101 |
|---|---|
| Subjects with at least 1 Adverse Event (AE) | 219 |
| Mild AE | 176 |
| Moderate AE | 43 |
| Severe AE | 0 |
| Life-threatening AE | 0 |
| Death AE | 0 |
| Subjects with at least 1 Serious Adverse Event (SAE) | 1 |
| Mild SAE | 0 |
| Moderate SAE | 1 |
| Severe SAE | 0 |
| Life-threatening SAE | 0 |
| Death SAE | 0 |
| Participants | AR101 |
|---|---|
| Number of Participants With Premature Discontinuation of Dosing Due to Adverse Events | 1 |
| Participants | AR101 |
|---|---|
| Number of Participants With Early Discontinuation of Dosing Due to Chronic/Recurrent GI Adverse Events | 1 |
| Participants | AR101 |
|---|---|
| < 2 weeks | 1 |
| 2-4 weeks | 0 |
| 4-12 weeks | 0 |
| ≥ 12 weeks | 0 |
| Participants | AR101 |
|---|---|
| Throat irritation | 43 |
| Pruritus | 39 |
| Abdominal pain | 30 |
| Abdominal discomfort | 28 |
| Urticaria | 27 |
| Cough | 24 |
| Anaphylactic reaction | 21 |
| Nausea | 19 |
| Vomiting | 19 |
| Rash | 17 |
| Oral pruritus | 14 |
| Rhinorrhoea | 14 |
Anaphylaxis is likely when any 1 of the 3 following sets of criteria is fulfilled: 1. Acute onset of an illness (minutes to hours) with involvement of: (a) Skin/mucosal tissue (eg, generalized hives, itch/flush, swollen lips/tongue/uvula); AND (b) Airway compromise (eg, dyspnea, stridor, wheeze/bronchospasm, hypoxia, reduced PEFR); AND/OR (c) Reduced BP or associated symptoms (eg, hypotonia, syncope, incontinence). 2. Two or more of the following that occur rapidly after exposure to the allergen (minutes to hours): (a) Skin/mucosal tissue; (b) Airway compromise; (c) Reduced BP or associated symptoms; (d) Persistent GI symptoms (eg, nausea, vomiting, crampy abdominal pain). 3. Reduced BP after exposure to the allergen (minutes to hours). Infants and children: low systolic BP (age-specific) or \> 30% drop in systolic BP; Adults: systolic BP \< 90 mm Hg or \> 30% drop from their baseline.
| Participants | AR101 |
|---|---|
| Number of Participants With of Anaphylaxis as Defined in the Protocol | 21 |
| Participants | AR101 |
|---|---|
| Number of Participants With Epinephrine Use as Rescue Medication | 19 |
Number of participants with accidental/nonaccidental ingestion of peanut (not AR101 or food challenge material) and other allergenic foods.
| Participants | AR101 |
|---|---|
| Number of Participants With Accidental/Nonaccidental Ingestion of Peanut and Other Allergenic Foods | 33 |
The C-ACT for subjects aged 4 to 11 years included 4 questions for the subject and 3 questions for the parent/caregiver; the total score (sum of 7 questions) ranged from 0 (worst control) to 27 (total control).
| score on a scale | AR101 |
|---|---|
| Baseline | 24 ± 2.58 |
| Maintenance Visit 1 | 24.4 ± 2.70 |
| Maintenance Visit 2 | 25.0 ± 1.97 |
| Maintenance Visit 3 | 25.0 ± 2.49 |
| Maintenance Visit 4 | 25.3 ± 1.88 |
| Maintenance Visit 5 | 24.8 ± 2.36 |
| Maintenance Visit 6 | 24.9 ± 2.31 |
| Early Discontinuation | 26.4 ± 0.89 |
| Exit Visit | 24.2 ± 3.15 |
| Change from Baseline to Study Exit | 0.5 ± 2.94 |
The ACT for subjects aged 12 to 17 years consisted of 5 questions, and the total score (sum of 5 questions) ranged from 5 (worst control) to 25 (total control).
| score on a scale | AR101 |
|---|---|
| Baseline | 23.3 ± 1.92 |
| Maintenance Visit 1 | 23.8 ± 1.70 |
| Maintenance Visit 2 | 23.9 ± 1.65 |
| Maintenance Visit 3 | 23.7 ± 2.32 |
| Maintenance Visit 4 | 23.3 ± 2.72 |
| Maintenance Visit 5 | 23.6 ± 2.14 |
| Maintenance Visit 6 | 23.8 ± 2.19 |
| Early Discontinuation | 21.5 ± 4.95 |
| Exit Visit | 23.5 ± 2.58 |
| Change from Baseline to Study Exit | 0.3 ± 2.68 |
| Participants | AR101 |
|---|---|
| Number of Participants With Adverse Events That Led to Early Withdrawal | 1 |
Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment Arm Description | 0/242 (0%) | 1/242 (0.4%) | 219/242 (90.5%) |
| Event | Treatment Arm Description |
|---|---|
| Anaphylactic reactionImmune system disorders | 1/242 |
| Event | Treatment Arm Description |
|---|---|
| CoughRespiratory, thoracic and mediastinal disorders | 47/242 |
| Abdominal discomfortGastrointestinal disorders | 45/242 |
| Throat irritationRespiratory, thoracic and mediastinal disorders | 43/242 |
| Upper respiratory tract infectionInfections and infestations | 42/242 |
| PruritusSkin and subcutaneous tissue disorders | 41/242 |
| VomitingGastrointestinal disorders | 39/242 |
| Abdominal painGastrointestinal disorders | 34/242 |
| UrticariaSkin and subcutaneous tissue disorders | 33/242 |
| HeadacheNervous system disorders | 31/242 |
| NauseaGastrointestinal disorders | 30/242 |
A total of 243 subjects were enrolled. However, only 242 subjects were included in Safety Population. The Safety Population is defined as all subjects who received at least 1 dose of AR101.
| Age, Continuous(years) | AR101 |
|---|---|
| Median | 9 (4 to 17) |
| Sex: Female, Male(Participants) | AR101 |
|---|---|
| Female | 84 |
| Male | 158 |
| Ethnicity (NIH/OMB)(Participants) | AR101 |
|---|---|
| Hispanic or Latino | 15 |
| Not Hispanic or Latino | 227 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | AR101 |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 31 |
| Native Hawaiian or Other Pacific Islander | 2 |
| Black or African American | 7 |
| White | 174 |
| More than one race | 25 |
| Unknown or Not Reported | 3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Panobacumab · Iclaprim, (r)-
Aimmune Therapeutics, Inc.