Oral Desensitization to Peanut in Peanut Allergic Children and Adults Using CPNA Peanut OIT Safety Follow-On Study
Sponsor
Aimmune Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02198664
Collaborator
(none)
47
8
2
40.3
5.9
0.1
Study Details
Study Description
Brief Summary
This is a multi-center, open-label, follow-on study to gather additional information on the safety and tolerability of oral desensitization with CPNA in the subjects who participated in ARC001.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
This phase 2, open-label, follow-on, multicenter study was designed to gather additional information on the safety, tolerability, and efficacy of oral desensitization with AR101 in subjects who participated in study ARC001 (NCT01987817) as follows:
-
Group 1 (ARC001 placebo): Subjects who received placebo in study ARC001
-
Group 2 (ARC001 AR101): Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001
All subjects will receive daily oral dosing of peanut OIT (oral immunotherapy) in the form of Characterized Peanut Allergen (CPNA).
Study Duration - 12-90 weeks before reaching the Extended Maintenance Phase. All Subjects may continue Extended Maintenance Phase until CPNA becomes commercially available or the study is terminated.
Study Design
Study Type:
Interventional
Actual Enrollment
:
47 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen (CPNA) Peanut Oral Immunotherapy (OIT) Safety Follow-On Study
Actual Study Start Date
:
Aug 27, 2014
Actual Primary Completion Date
:
Jan 4, 2018
Actual Study Completion Date
:
Jan 4, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ARC001 placebo group Subjects who received placebo in study ARC001. |
Biological: AR101 - Peanut protein capsule
Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)
|
| Experimental: ARC001 AR101 group Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001. |
Biological: AR101 - Peanut protein capsule
Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Treatment-related Adverse Events and Dosing Symptoms Occurring With Peanut OIT Over a Protracted Treatment Period Comprising at Least 18 Months [Up to 90 weeks]
TEAEs are any event starting during or after the active treatment period. If a subject has multiple occurrences of TEAEs, the subject is presented once in the respective subject count (n).
Secondary Outcome Measures
- The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg) and 600 mg (1043 mg Cumulative) Peanut Protein With no More Than Mild Symptoms During the Up-dosing DBPCFC [Up to 36 weeks]
- The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg), 600 mg (1043 mg Cumulative), and 1000 mg Peanut Protein (2043 mg Cumulative) With no More Than Mild Symptoms During the Maintenance DBPCFC. [Up to 60 weeks.]
- Change From Baseline in the Single Highest Tolerated Dose of Peanut Protein [Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance)]
The single highest tolerated dose of peanut protein with no more than mild symptoms during the up-dosing DBPCFC and the change from baseline was evaluated for the ARC001 placebo completer population. The single highest tolerated dose of peanut protein with no more than mild symptoms during the maintenance DBPCFC and the change from up-dosing DBPCFC was evaluated for each group (ARC001 AR101 and ARC001 placebo) and overall for the food challenge completer population.
- Number of Participants Who Tolerated Maximum Dose of Peanut Protein With no More Than Mild Symptoms Maximum Dose of Peanut Protein Tolerated [Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance)]
The maximum dose of peanut protein tolerated with no more than mild symptoms during the up-dosing and maintenance DBPCFCs
- Change in Peanut-specific IgE From Baseline and Up-dosing to Extended Maintenance [Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks)]
- Change in Peanut-specific IgG4 From Baseline and Up-dosing to Extended Maintenance [Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks)]
- Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter and Peanut Erythema/Flare From Baseline and Up-dosing to Extended Maintenance [Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks)]
- Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC [Up to 36 weeks for up-dosing]
Maximum severity of symptoms that occurred at each challenge dose of peanut protein for all subjects during up-dosing DBPCFC
- Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC [Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance)]
Maximum severity of symptoms that occurred at each challenge dose of peanut protein for all subjects during maintenance DBPCFC
- Change in Physician Global Assessment, Disease Activity as Measured on a 100 mm Visual Analogue Scale (VAS) From Baseline and Up-dosing to Extended Maintenance. [Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks)]
A 100-mm Visual Analog Scale (VAS) was used by the investigators for the Physician Global Assessment of disease activity as a marker for safety. The investigator was to assign a single integrated overall disease activity score ranging from 0 to 100 mm. Zero indicated no disease activity and 100 indicated very severe disease activity.
Eligibility Criteria
Criteria
Ages Eligible for Study:
4 Years
to 26 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Key Inclusion Criteria:
-
Completion of ARC001 study
-
No change in the status of any longitudinally applicable ARC001 inclusion criteria
Key Exclusion Criteria:
-
Early termination from ARC001
-
Failure to tolerate 300 mg of peanut protein in the ARC001 exit food challenge
-
A lapse in dosing of more than 10 days from completion of ARC001
-
Change in the status of any longitudinally applicable ARC001 exclusion criteria
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Arkansas Children's Hospital | Little Rock | Arkansas | United States | 72202 |
| 2 | UC San Diego | San Diego | California | United States | 92123 |
| 3 | Boston Children's Hospital | Boston | Massachusetts | United States | 02115 |
| 4 | Mount Sinai Medical Center | New York | New York | United States | 10029 |
| 5 | University of North Carolina Chapel HIll | Chapel Hill | North Carolina | United States | 25799 |
| 6 | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | United States | 45229 |
| 7 | The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | United States | 19104 |
| 8 | Children's Medical Center Dallas | Dallas | Texas | United States | 75235 |
Sponsors and Collaborators
- Aimmune Therapeutics, Inc.
Investigators
- Study Director: Director of Regulatory Affairs, Aimmune Therapeutics
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Aimmune Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT02198664
Other Study ID Numbers:
- ARC002
First Posted:
Jul 24, 2014
Last Update Posted:
Nov 9, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Aimmune Therapeutics, Inc.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | ARC001 Placebo Group | ARC001 AR101 Group |
|---|---|---|
| Arm/Group Description | Subjects who received placebo in study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg) | Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg) |
| Period Title: Overall Study | ||
| STARTED | 26 | 21 |
| COMPLETED | 10 | 13 |
| NOT COMPLETED | 16 | 8 |
Baseline Characteristics
| Arm/Group Title | ARC001 Placebo Group | ARC001 AR101 Group | Total |
|---|---|---|---|
| Arm/Group Description | Subjects who received placebo in study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg) | Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg) | Total of all reporting groups |
| Overall Participants | 26 | 21 | 47 |
| Age (years) [Median (Full Range) ] | |||
| Median (Full Range) [years] |
8.5
|
8.0
|
8.0
|
| Age, Customized (Count of Participants) | |||
| 4-17 years |
26
100%
|
20
95.2%
|
46
97.9%
|
| 18-26 years |
0
0%
|
1
4.8%
|
1
2.1%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
10
38.5%
|
7
33.3%
|
17
36.2%
|
| Male |
16
61.5%
|
14
66.7%
|
30
63.8%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
26
100%
|
21
100%
|
47
100%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
1
3.8%
|
0
0%
|
1
2.1%
|
| Asian |
1
3.8%
|
1
4.8%
|
2
4.3%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
2
7.7%
|
1
4.8%
|
3
6.4%
|
| White |
20
76.9%
|
18
85.7%
|
38
80.9%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
2
7.7%
|
1
4.8%
|
3
6.4%
|
Outcome Measures
| Title | Number of Participants With Treatment-related Adverse Events and Dosing Symptoms Occurring With Peanut OIT Over a Protracted Treatment Period Comprising at Least 18 Months |
|---|---|
| Description | TEAEs are any event starting during or after the active treatment period. If a subject has multiple occurrences of TEAEs, the subject is presented once in the respective subject count (n). |
| Time Frame | Up to 90 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Safety Population (those who received any amount of AR101) |
| Arm/Group Title | ARC001 Placebo Group | ARC001 AR101 Group |
|---|---|---|
| Arm/Group Description | Subjects who received placebo in study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg) | Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg) |
| Measure Participants | 26 | 21 |
| Any TEAE |
26
100%
|
21
100%
|
| Any Grade 3 or Higher TEAE |
1
3.8%
|
1
4.8%
|
| Any TEAE Related to Study Treatment |
25
96.2%
|
15
71.4%
|
| Any TEAE Leading to Study Treatment Temporarily Withdrawn |
12
46.2%
|
15
71.4%
|
| Any TEAE Event Leading to Study Treatment Permanently Withdrawn |
4
15.4%
|
0
0%
|
| Any Treatment-Related Hypersensitivity Adverse Event |
5
19.2%
|
4
19%
|
| Any serious TEAE |
0
0%
|
1
4.8%
|
| Any Serious TEAE leading to Death |
0
0%
|
0
0%
|
| Title | The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg) and 600 mg (1043 mg Cumulative) Peanut Protein With no More Than Mild Symptoms During the Up-dosing DBPCFC |
|---|---|
| Description | |
| Time Frame | Up to 36 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Safety Population (those who received any amount of AR101). Only results for the "ARC001 AR101 Group" is reported as only subjects in this group had Up-dosing DBPCFC in ARC002 study. |
| Arm/Group Title | ARC001 Placebo Group |
|---|---|
| Arm/Group Description | Subjects who received placebo in study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg) |
| Measure Participants | 26 |
| Up-dosing DBPCFC: Responder at 300 mg |
20
76.9%
|
| Up-dosing DBPCFC: Responder at 600 mg |
19
73.1%
|
| Title | The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg), 600 mg (1043 mg Cumulative), and 1000 mg Peanut Protein (2043 mg Cumulative) With no More Than Mild Symptoms During the Maintenance DBPCFC. |
|---|---|
| Description | |
| Time Frame | Up to 60 weeks. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Safety Population (those who received any amount of AR101). Multiple food challenge dose levels were given at each DBPCFC, so results at 300 mg and 600 mg for Maintenance DBPCFC are not expected to match those for Up-dosing DBPCFC. |
| Arm/Group Title | ARC001 Placebo Group | ARC001 AR101 Group |
|---|---|---|
| Arm/Group Description | Subjects who received placebo in study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg) | Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg) |
| Measure Participants | 26 | 21 |
| Maintenance DBPCFC: Responder at 300 mg |
20
76.9%
|
20
95.2%
|
| Maintenance DBPCC: Responder at 600 mg |
20
76.9%
|
18
85.7%
|
| Maintenance DBPCC: Responder at 1000 mg |
17
65.4%
|
14
66.7%
|
| Title | Change From Baseline in the Single Highest Tolerated Dose of Peanut Protein |
|---|---|
| Description | The single highest tolerated dose of peanut protein with no more than mild symptoms during the up-dosing DBPCFC and the change from baseline was evaluated for the ARC001 placebo completer population. The single highest tolerated dose of peanut protein with no more than mild symptoms during the maintenance DBPCFC and the change from up-dosing DBPCFC was evaluated for each group (ARC001 AR101 and ARC001 placebo) and overall for the food challenge completer population. |
| Time Frame | Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Only includes food challenge completer population |
| Arm/Group Title | ARC001 Placebo Group | ARC001 AR101 Group |
|---|---|---|
| Arm/Group Description | Subjects who received placebo in study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg) | Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg) |
| Measure Participants | 26 | 21 |
| AR101 baseline (mg) [2] |
38.90
(4.37)
|
NA
(NA)
|
| Up-dosing DBPCFC |
501.2
(1.55)
|
524.8
(1.32)
|
| Maintenance DBPCFC |
776.2
(1.41)
|
758.6
(1.55)
|
| Title | Number of Participants Who Tolerated Maximum Dose of Peanut Protein With no More Than Mild Symptoms Maximum Dose of Peanut Protein Tolerated |
|---|---|
| Description | The maximum dose of peanut protein tolerated with no more than mild symptoms during the up-dosing and maintenance DBPCFCs |
| Time Frame | Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Only includes food challenge completer population |
| Arm/Group Title | ARC001 Placebo Group | ARC001 AR101 Group |
|---|---|---|
| Arm/Group Description | Subjects who received placebo in study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg) | Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg) |
| Measure Participants | 26 | 21 |
| 100 mg |
1
3.8%
|
0
0%
|
| 300 mg |
3
11.5%
|
4
19%
|
| 600 mg |
17
65.4%
|
17
81%
|
| 1000 mg |
NA
NaN
|
NA
NaN
|
| 100 mg |
0
0%
|
0
0%
|
| 300 mg |
1
3.8%
|
3
14.3%
|
| 600 mg |
8
30.8%
|
4
19%
|
| 1000 mg |
11
42.3%
|
13
61.9%
|
| Title | Change in Peanut-specific IgE From Baseline and Up-dosing to Extended Maintenance |
|---|---|
| Description | |
| Time Frame | Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Safety Population (those who received any amount of AR101) |
| Arm/Group Title | ARC001 Placebo Group | ARC001 AR101 Group |
|---|---|---|
| Arm/Group Description | Subjects who received placebo in study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg) | Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg) |
| Measure Participants | 26 | 21 |
| Baseline: Peanut-specific IgE |
56.826
(2.8864)
|
NA
(NA)
|
| Up-dosing: Peanut-specific IgE |
59.145
(2.9154)
|
29.964
(4.4817)
|
| Extended maintenance: Peanut-specific IgE |
14.880
(6.7531)
|
10.381
(4.0149)
|
| Change from baseline: Peanut-specific IgE |
0.387
(2.2479)
|
NA
(NA)
|
| Change from up-dosing: Peanut-specific IgE |
0.364
(2.8292)
|
0.228
(2.0544)
|
| Title | Change in Peanut-specific IgG4 From Baseline and Up-dosing to Extended Maintenance |
|---|---|
| Description | |
| Time Frame | Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Safety Population (those who received any amount of AR101) |
| Arm/Group Title | ARC001 Placebo Group | ARC001 AR101 Group |
|---|---|---|
| Arm/Group Description | Subjects who received placebo in study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg) | Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg) |
| Measure Participants | 26 | 21 |
| Baseline: Peanut-specific IgG4 |
0.538
(2.4351)
|
NA
(NA)
|
| Up-dosing: Peanut-specific IgG4 |
3.004
(3.8962)
|
4.096
(3.9749)
|
| Extended maintenance: Peanut-specific IgG4 |
5.755
(3.6328)
|
12.429
(2.8292)
|
| Change from baseline: Peanut-specific IgG4 |
12.429
(2.2705)
|
NA
(NA)
|
| Change from up-dosing: Peanut-specific IgG4 |
1.682
(3.1268)
|
2.746
(3.4556)
|
| Title | Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter and Peanut Erythema/Flare From Baseline and Up-dosing to Extended Maintenance |
|---|---|
| Description | |
| Time Frame | Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Safety Population (those who received any amount of AR101) |
| Arm/Group Title | ARC001 Placebo Group | ARC001 AR101 Group |
|---|---|---|
| Arm/Group Description | Subjects who received placebo in study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg) | Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg) |
| Measure Participants | 26 | 21 |
| Peanut wheal diameter; baseline |
11.8
(6.29)
|
NA
(NA)
|
| Peanut wheal diameter; up-dosing |
8.6
(4.62)
|
6.6
(3.04)
|
| Peanut wheal diameter; extended maintenance |
9.0
(5.77)
|
5.1
(3.40)
|
| Change from baseline: Peanut wheal diameter |
-1.5
(6.52)
|
NA
(NA)
|
| Change from up-dosing: Peanut wheal diameter |
-0.8
(4.72)
|
-0.7
(2.98)
|
| Peanut erythema/flare; baseline |
37.6
(17.69)
|
NA
(NA)
|
| Peanut erythema/flare; up-dosing |
26.8
(12.05)
|
21.8
(8.76)
|
| Peanut erythema/flare; extended maintenance |
28.2
(19.73)
|
14.7
(11.62)
|
| Change from baseline: peanut erythema/flare |
-8.7
(15.35)
|
NA
(NA)
|
| Change from up-dosing: peanut erythema/flare |
-1.8
(11.55)
|
-5.4
(9.79)
|
| Title | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC |
|---|---|
| Description | Maximum severity of symptoms that occurred at each challenge dose of peanut protein for all subjects during up-dosing DBPCFC |
| Time Frame | Up to 36 weeks for up-dosing |
Outcome Measure Data
| Analysis Population Description |
|---|
| Only subjects who completed the food challenge at each challenge dose during the Up-dosing DBPCFC were analyzed |
| Arm/Group Title | ARC001 Placebo Group | ARC001 AR101 Group |
|---|---|---|
| Arm/Group Description | Subjects who received placebo in study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg | Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg) |
| Measure Participants | 21 | 21 |
| None |
11
42.3%
|
18
85.7%
|
| Mild |
0
0%
|
3
14.3%
|
| Moderate |
0
0%
|
0
0%
|
| Severe |
0
0%
|
0
0%
|
| Missing |
10
38.5%
|
0
0%
|
| None |
10
38.5%
|
21
100%
|
| Mild |
1
3.8%
|
0
0%
|
| Moderate |
0
0%
|
0
0%
|
| Severe |
0
0%
|
0
0%
|
| Missing |
10
38.5%
|
0
0%
|
| None |
10
38.5%
|
20
95.2%
|
| Mild |
2
7.7%
|
1
4.8%
|
| Moderate |
0
0%
|
0
0%
|
| Severe |
0
0%
|
0
0%
|
| Missing |
9
34.6%
|
0
0%
|
| None |
11
42.3%
|
18
85.7%
|
| Mild |
1
3.8%
|
3
14.3%
|
| Moderate |
0
0%
|
0
0%
|
| Severe |
0
0%
|
0
0%
|
| Missing |
9
34.6%
|
0
0%
|
| None |
7
26.9%
|
20
95.2%
|
| Mild |
4
15.4%
|
1
4.8%
|
| Moderate |
0
0%
|
0
0%
|
| Severe |
0
0%
|
0
0%
|
| Missing |
10
38.5%
|
0
0%
|
| None |
6
23.1%
|
12
57.1%
|
| Mild |
6
23.1%
|
5
23.8%
|
| Moderate |
0
0%
|
4
19%
|
| Severe |
0
0%
|
0
0%
|
| Missing |
9
34.6%
|
0
0%
|
| Title | Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC |
|---|---|
| Description | Maximum severity of symptoms that occurred at each challenge dose of peanut protein for all subjects during maintenance DBPCFC |
| Time Frame | Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Only subjects who completed the food challenge at each challenge dose during the Maintenance DBPCFC were analyzed |
| Arm/Group Title | ARC001 Placebo Group | ARC001 AR101 Group |
|---|---|---|
| Arm/Group Description | Subjects who received placebo in study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg). | Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg) |
| Measure Participants | 20 | 20 |
| None |
7
26.9%
|
9
42.9%
|
| Mild |
0
0%
|
1
4.8%
|
| Moderate |
0
0%
|
0
0%
|
| Severe |
0
0%
|
0
0%
|
| Missing |
13
50%
|
10
47.6%
|
| None |
6
23.1%
|
9
42.9%
|
| Mild |
0
0%
|
0
0%
|
| Moderate |
0
0%
|
0
0%
|
| Severe |
0
0%
|
0
0%
|
| Missing |
14
53.8%
|
11
52.4%
|
| None |
6
23.1%
|
9
42.9%
|
| Mild |
0
0%
|
1
4.8%
|
| Moderate |
0
0%
|
0
0%
|
| Severe |
0
0%
|
0
0%
|
| Missing |
14
53.8%
|
10
47.6%
|
| None |
6
23.1%
|
9
42.9%
|
| Mild |
1
3.8%
|
0
0%
|
| Moderate |
0
0%
|
0
0%
|
| Severe |
0
0%
|
0
0%
|
| Missing |
13
50%
|
11
52.4%
|
| None |
6
23.1%
|
8
38.1%
|
| Mild |
0
0%
|
1
4.8%
|
| Moderate |
0
0%
|
0
0%
|
| Severe |
0
0%
|
0
0%
|
| Missing |
14
53.8%
|
11
52.4%
|
| None |
7
26.9%
|
7
33.3%
|
| Mild |
2
7.7%
|
3
14.3%
|
| Moderate |
0
0%
|
1
4.8%
|
| Severe |
0
0%
|
0
0%
|
| Missing |
11
42.3%
|
9
42.9%
|
| None |
5
19.2%
|
7
33.3%
|
| Mild |
7
26.9%
|
4
19%
|
| Moderate |
2
7.7%
|
2
9.5%
|
| Severe |
0
0%
|
1
4.8%
|
| Missing |
6
23.1%
|
6
28.6%
|
| Title | Change in Physician Global Assessment, Disease Activity as Measured on a 100 mm Visual Analogue Scale (VAS) From Baseline and Up-dosing to Extended Maintenance. |
|---|---|
| Description | A 100-mm Visual Analog Scale (VAS) was used by the investigators for the Physician Global Assessment of disease activity as a marker for safety. The investigator was to assign a single integrated overall disease activity score ranging from 0 to 100 mm. Zero indicated no disease activity and 100 indicated very severe disease activity. |
| Time Frame | Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Safety Population (those who received any amount of AR101) |
| Arm/Group Title | ARC001 Placebo Group | ARC001 AR101 Group |
|---|---|---|
| Arm/Group Description | Subjects who received placebo in study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg) | Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg) |
| Measure Participants | 26 | 21 |
| Baseline |
36.4
(24.31)
|
NA
(NA)
|
| Up-dosing |
34.9
(21.42)
|
25.6
(17.78)
|
| Extended maintenance |
27.5
(25.03)
|
20.1
(12.61)
|
| Change from baseline |
-26.30
(34.50)
|
NA
(NA)
|
| Change from up-dosing |
-20.00
(38.87)
|
-15.5
(20.56)
|
Adverse Events
| Time Frame | 90 weeks | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | A multi-page adverse event form was used allowing all adverse events to be submitted through a single reporting mechanism. Study investigators will provide the Coordinating Center with data of all SAEs as defined per the protocol on an ongoing basis, within 24 h of site awareness of the event. The sponsor's Medical Monitor will review each SAE report and will determine whether the SAE must be reported to FDA on an expedited basis. | |||
| Arm/Group Title | ARC001 Placebo Group | ARC001 AR101 Group | ||
| Arm/Group Description | Subjects who received placebo in study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg) | Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001. AR101 - Peanut protein provided in capsules: Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg) | ||
All Cause Mortality |
||||
| ARC001 Placebo Group | ARC001 AR101 Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/26 (0%) | 0/21 (0%) | ||
Serious Adverse Events |
||||
| ARC001 Placebo Group | ARC001 AR101 Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/26 (0%) | 1/21 (4.8%) | ||
| Immune system disorders | ||||
| Anaphylactic reaction | 0/26 (0%) | 1/21 (4.8%) | ||
Other (Not Including Serious) Adverse Events |
||||
| ARC001 Placebo Group | ARC001 AR101 Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 26/26 (100%) | 21/21 (100%) | ||
| Ear and labyrinth disorders | ||||
| Ear pruritus | 3/26 (11.5%) | 0/21 (0%) | ||
| Eye disorders | ||||
| Eye pruritus | 1/26 (3.8%) | 2/21 (9.5%) | ||
| Gastrointestinal disorders | ||||
| Abdominal pain | 15/26 (57.7%) | 9/21 (42.9%) | ||
| Vomiting | 15/26 (57.7%) | 8/21 (38.1%) | ||
| Abdominal pain upper | 7/26 (26.9%) | 7/21 (33.3%) | ||
| Nausea | 7/26 (26.9%) | 6/21 (28.6%) | ||
| Oral pruritus | 6/26 (23.1%) | 2/21 (9.5%) | ||
| Abdominal discomfort | 3/26 (11.5%) | 3/21 (14.3%) | ||
| Diarrhoea | 3/26 (11.5%) | 3/21 (14.3%) | ||
| Lip swelling | 4/26 (15.4%) | 2/21 (9.5%) | ||
| Dyspepsia | 3/26 (11.5%) | 1/21 (4.8%) | ||
| Constipation | 2/26 (7.7%) | 1/21 (4.8%) | ||
| Gastritis | 2/26 (7.7%) | 1/21 (4.8%) | ||
| Lip pruritus | 1/26 (3.8%) | 2/21 (9.5%) | ||
| General disorders | ||||
| Pyrexia | 7/26 (26.9%) | 6/21 (28.6%) | ||
| Chest discomfort | 1/26 (3.8%) | 2/21 (9.5%) | ||
| Malaise | 1/26 (3.8%) | 2/21 (9.5%) | ||
| Immune system disorders | ||||
| Hypersensitivity | 6/26 (23.1%) | 7/21 (33.3%) | ||
| Anaphylactic reaction | 4/26 (15.4%) | 2/21 (9.5%) | ||
| Seasonal allergy | 1/26 (3.8%) | 3/21 (14.3%) | ||
| Food allergy | 0/26 (0%) | 3/21 (14.3%) | ||
| Infections and infestations | ||||
| Pharyngitis streptococcal | 10/26 (38.5%) | 5/21 (23.8%) | ||
| Upper respiratory tract infection | 7/26 (26.9%) | 8/21 (38.1%) | ||
| Gastroenteritis viral | 4/26 (15.4%) | 5/21 (23.8%) | ||
| Viral infection | 5/26 (19.2%) | 4/21 (19%) | ||
| Gastroenteritis | 3/26 (11.5%) | 5/21 (23.8%) | ||
| Nasopharyngitis | 4/26 (15.4%) | 4/21 (19%) | ||
| Otitis media | 3/26 (11.5%) | 2/21 (9.5%) | ||
| Ear infection | 2/26 (7.7%) | 2/21 (9.5%) | ||
| Influenza | 2/26 (7.7%) | 2/21 (9.5%) | ||
| Injury, poisoning and procedural complications | ||||
| Arthropod bite | 3/26 (11.5%) | 1/21 (4.8%) | ||
| Joint injury | 2/26 (7.7%) | 1/21 (4.8%) | ||
| Ligament sprain | 2/26 (7.7%) | 1/21 (4.8%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Musculoskeletal discomfort | 3/26 (11.5%) | 0/21 (0%) | ||
| Nervous system disorders | ||||
| Headache | 6/26 (23.1%) | 8/21 (38.1%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 11/26 (42.3%) | 6/21 (28.6%) | ||
| Nasal congestion | 9/26 (34.6%) | 7/21 (33.3%) | ||
| Oropharyngeal pain | 7/26 (26.9%) | 4/21 (19%) | ||
| Rhinorrhoea | 6/26 (23.1%) | 5/21 (23.8%) | ||
| Sneezing | 8/26 (30.8%) | 3/21 (14.3%) | ||
| Throat irritation | 6/26 (23.1%) | 5/21 (23.8%) | ||
| Rhinitis allergic | 6/26 (23.1%) | 3/21 (14.3%) | ||
| Wheezing | 7/26 (26.9%) | 2/21 (9.5%) | ||
| Nasal turbinate hypertrophy | 3/26 (11.5%) | 1/21 (4.8%) | ||
| Asthma | 2/26 (7.7%) | 1/21 (4.8%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Urticaria | 7/26 (26.9%) | 5/21 (23.8%) | ||
| Rash | 5/26 (19.2%) | 5/21 (23.8%) | ||
| Pruritus | 5/26 (19.2%) | 4/21 (19%) | ||
| Eczema | 1/26 (3.8%) | 3/21 (14.3%) | ||
| Erythema | 2/26 (7.7%) | 1/21 (4.8%) | ||
| Vascular disorders | ||||
| Flushing | 3/26 (11.5%) | 0/21 (0%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Institutions cannot publish until the multi-center sponsor publication is published Or, institutions cannot publish until 18 months after study completion And Sponsor review of any publications is required prior to any institution publications according to contractual agreements
Results Point of Contact
| Name/Title | Director of Regulatory Affairs |
|---|---|
| Organization | Aimmune Therapeutics, Inc. |
| Phone | 650-409-5164 |
| RegulatoryAffairs@aimmune.com |
Responsible Party:
Aimmune Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT02198664
Other Study ID Numbers:
- ARC002
First Posted:
Jul 24, 2014
Last Update Posted:
Nov 9, 2021
Last Verified:
Nov 1, 2021