Trial Outcomes & Findings for Peanut Oral Immunotherapy Study of Early Intervention for Desensitization (NCT NCT03736447)
NCT ID: NCT03736447
Last Updated: 2023-03-02
Results Overview
The percentage of subjects in the ITT population who achieve desensitization as determined by tolerating specified challenge doses of peanut protein with no more than mild allergy symptoms during the exit double-blind placebo-controlled food challenge (DBPCFC).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
146 participants
Primary outcome timeframe
12 months
Results posted on
2023-03-02
Participant Flow
Participant milestones
| Measure |
AR101
AR101 drug product was supplied in 2 presentations. These were pull-apart capsules containing 0.5, 1, 10, 20 and 100mg of peanut protein and sealed, foil-laminated sachets containing 300mg of peanut protein. Contents were delivered over an age-appropriate semisolid, vehicle food and mixed thoroughly.
The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase.
|
Placebo
A Placebo matching the AR101 drug product was supplied in 2 presentations. These were pull-apart capsules matching the 0.5, 1, 10, 20 and 100mg peanut capsules but containing no peanut protein, and sealed, foil-laminated sachets matching the peanut protein sachets but without any peanut protein. Contents were delivered over an age-appropriate semisolid, vehicle food and mixed thoroughly.
The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase.
|
|---|---|---|
|
Overall Study
STARTED
|
98
|
48
|
|
Overall Study
COMPLETED
|
83
|
45
|
|
Overall Study
NOT COMPLETED
|
15
|
3
|
Reasons for withdrawal
| Measure |
AR101
AR101 drug product was supplied in 2 presentations. These were pull-apart capsules containing 0.5, 1, 10, 20 and 100mg of peanut protein and sealed, foil-laminated sachets containing 300mg of peanut protein. Contents were delivered over an age-appropriate semisolid, vehicle food and mixed thoroughly.
The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase.
|
Placebo
A Placebo matching the AR101 drug product was supplied in 2 presentations. These were pull-apart capsules matching the 0.5, 1, 10, 20 and 100mg peanut capsules but containing no peanut protein, and sealed, foil-laminated sachets matching the peanut protein sachets but without any peanut protein. Contents were delivered over an age-appropriate semisolid, vehicle food and mixed thoroughly.
The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase.
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Continued commitment to study treatment
|
3
|
0
|
|
Overall Study
Taste aversion to study product
|
0
|
1
|
Baseline Characteristics
Peanut Oral Immunotherapy Study of Early Intervention for Desensitization
Baseline characteristics by cohort
| Measure |
AR101
n=98 Participants
AR101 drug product was supplied in 2 presentations. These were pull-apart capsules containing 0.5, 1, 10, 20 and 100mg of peanut protein and sealed, foil-laminated sachets containing 300mg of peanut protein. Contents were delivered over an age-appropriate semisolid, vehicle food and mixed thoroughly.
The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase.
|
Placebo
n=48 Participants
A Placebo matching the AR101 drug product was supplied in 2 presentations. These were pull-apart capsules matching the 0.5, 1, 10, 20 and 100mg peanut capsules but containing no peanut protein, and sealed, foil-laminated sachets matching the peanut protein sachets but without any peanut protein. Contents were delivered over an age-appropriate semisolid, vehicle food and mixed thoroughly.
The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase.
|
Total
n=146 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
1-<2 years
|
33 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Age, Customized
2-<3 years
|
35 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Age, Customized
3-<4 years
|
30 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
75 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
18 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
16 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
65 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsThe percentage of subjects in the ITT population who achieve desensitization as determined by tolerating specified challenge doses of peanut protein with no more than mild allergy symptoms during the exit double-blind placebo-controlled food challenge (DBPCFC).
Outcome measures
| Measure |
AR101
n=98 Participants
AR101 drug product was supplied in 2 presentations. These were pull-apart capsules containing 0.5, 1, 10, 20 and 100mg of peanut protein and sealed, foil-laminated sachets containing 300mg of peanut protein. Contents were delivered over an age-appropriate semisolid, vehicle food and mixed thoroughly.
The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase.
|
Placebo
n=48 Participants
A Placebo matching the AR101 drug product was supplied in 2 presentations. These were pull-apart capsules matching the 0.5, 1, 10, 20 and 100mg peanut capsules but containing no peanut protein, and sealed, foil-laminated sachets matching the peanut protein sachets but without any peanut protein. Contents were delivered over an age-appropriate semisolid, vehicle food and mixed thoroughly.
The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase.
|
|---|---|---|
|
Percentage of Subjects Who Tolerated a Single Highest Dose of at Least 600 mg in the Exit Double-Blind, Placebo-Controlled Food Challenge (DBPCFC)
|
73.5 Percentage of subjects
Interval 63.6 to 81.9
|
6.3 Percentage of subjects
Interval 1.3 to 17.2
|
SECONDARY outcome
Timeframe: 12 monthsThe percentage of subjects in the ITT population who achieve desensitization as determined by tolerating specified challenge doses of peanut protein with no more than mild allergy symptoms during the exit double-blind placebo-controlled food challenge (DBPCFC).
Outcome measures
| Measure |
AR101
n=98 Participants
AR101 drug product was supplied in 2 presentations. These were pull-apart capsules containing 0.5, 1, 10, 20 and 100mg of peanut protein and sealed, foil-laminated sachets containing 300mg of peanut protein. Contents were delivered over an age-appropriate semisolid, vehicle food and mixed thoroughly.
The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase.
|
Placebo
n=46 Participants
A Placebo matching the AR101 drug product was supplied in 2 presentations. These were pull-apart capsules matching the 0.5, 1, 10, 20 and 100mg peanut capsules but containing no peanut protein, and sealed, foil-laminated sachets matching the peanut protein sachets but without any peanut protein. Contents were delivered over an age-appropriate semisolid, vehicle food and mixed thoroughly.
The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase.
|
|---|---|---|
|
Percentage of Subjects Who Tolerated a Single Highest Dose of at Least 1000 mg in the Exit Double-Blind, Placebo-Controlled Food Challenge (DBPCFC) [Time Frame: 12 Months]
|
68.4 Percent of participants
Interval 58.2 to 77.4
|
4.2 Percent of participants
Interval 0.5 to 14.3
|
SECONDARY outcome
Timeframe: 12 monthsThe percentage of subjects in the ITT population who achieve desensitization as determined by tolerating specified challenge doses of peanut protein with no more than mild allergy symptoms during the exit double-blind placebo-controlled food challenge (DBPCFC).
Outcome measures
| Measure |
AR101
n=98 Participants
AR101 drug product was supplied in 2 presentations. These were pull-apart capsules containing 0.5, 1, 10, 20 and 100mg of peanut protein and sealed, foil-laminated sachets containing 300mg of peanut protein. Contents were delivered over an age-appropriate semisolid, vehicle food and mixed thoroughly.
The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase.
|
Placebo
n=48 Participants
A Placebo matching the AR101 drug product was supplied in 2 presentations. These were pull-apart capsules matching the 0.5, 1, 10, 20 and 100mg peanut capsules but containing no peanut protein, and sealed, foil-laminated sachets matching the peanut protein sachets but without any peanut protein. Contents were delivered over an age-appropriate semisolid, vehicle food and mixed thoroughly.
The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase.
|
|---|---|---|
|
Percentage of Subjects Who Tolerated a Single Highest Dose of at Least 300 mg in the Exit Double-Blind, Placebo-Controlled Food Challenge (DBPCFC)
|
79.6 Percentage of subjects
Interval 70.3 to 87.1
|
22.9 Percentage of subjects
Interval 12.0 to 37.3
|
SECONDARY outcome
Timeframe: 12 monthsThe maximum severity of symptoms that occurred at any challenge dose of peanut protein during the exit DBPCFC.
Outcome measures
| Measure |
AR101
n=98 Participants
AR101 drug product was supplied in 2 presentations. These were pull-apart capsules containing 0.5, 1, 10, 20 and 100mg of peanut protein and sealed, foil-laminated sachets containing 300mg of peanut protein. Contents were delivered over an age-appropriate semisolid, vehicle food and mixed thoroughly.
The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase.
|
Placebo
n=48 Participants
A Placebo matching the AR101 drug product was supplied in 2 presentations. These were pull-apart capsules matching the 0.5, 1, 10, 20 and 100mg peanut capsules but containing no peanut protein, and sealed, foil-laminated sachets matching the peanut protein sachets but without any peanut protein. Contents were delivered over an age-appropriate semisolid, vehicle food and mixed thoroughly.
The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase.
|
|---|---|---|
|
Maximum Severity of Symptoms in Participants at Any Challenge Dose During the Exit Double-blind Placebo Controlled Food Challenge (DBPCFC)
None
|
50 Participants
|
2 Participants
|
|
Maximum Severity of Symptoms in Participants at Any Challenge Dose During the Exit Double-blind Placebo Controlled Food Challenge (DBPCFC)
Mild
|
29 Participants
|
23 Participants
|
|
Maximum Severity of Symptoms in Participants at Any Challenge Dose During the Exit Double-blind Placebo Controlled Food Challenge (DBPCFC)
Moderate
|
17 Participants
|
21 Participants
|
|
Maximum Severity of Symptoms in Participants at Any Challenge Dose During the Exit Double-blind Placebo Controlled Food Challenge (DBPCFC)
Severe
|
2 Participants
|
2 Participants
|
|
Maximum Severity of Symptoms in Participants at Any Challenge Dose During the Exit Double-blind Placebo Controlled Food Challenge (DBPCFC)
Life-threatening or fatal
|
0 Participants
|
0 Participants
|
Adverse Events
AR101
Serious events: 7 serious events
Other events: 96 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AR101
n=98 participants at risk
AR101 drug product was supplied in 2 presentations. These were pull-apart capsules containing 0.5, 1, 10, 20 and 100mg of peanut protein and sealed, foil-laminated sachets containing 300mg of peanut protein. Contents were delivered over an age-appropriate semisolid, vehicle food and mixed thoroughly.
The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase.
|
Placebo
n=48 participants at risk
A Placebo matching the AR101 drug product was supplied in 2 presentations. These were pull-apart capsules matching the 0.5, 1, 10, 20 and 100mg peanut capsules but containing no peanut protein, and sealed, foil-laminated sachets matching the peanut protein sachets but without any peanut protein. Contents were delivered over an age-appropriate semisolid, vehicle food and mixed thoroughly.
The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase.
|
|---|---|---|
|
Infections and infestations
Enterovirus infection
|
1.0%
1/98 • 12 months
|
0.00%
0/48 • 12 months
|
|
Infections and infestations
Influenza
|
1.0%
1/98 • 12 months
|
0.00%
0/48 • 12 months
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
1.0%
1/98 • 12 months
|
0.00%
0/48 • 12 months
|
|
Infections and infestations
Viral infection
|
1.0%
1/98 • 12 months
|
0.00%
0/48 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.0%
2/98 • 12 months
|
2.1%
1/48 • 12 months
|
|
Infections and infestations
Status asthmaticus
|
1.0%
1/98 • 12 months
|
0.00%
0/48 • 12 months
|
|
Injury, poisoning and procedural complications
Carbon monoxide poisoning
|
0.00%
0/98 • 12 months
|
2.1%
1/48 • 12 months
|
Other adverse events
| Measure |
AR101
n=98 participants at risk
AR101 drug product was supplied in 2 presentations. These were pull-apart capsules containing 0.5, 1, 10, 20 and 100mg of peanut protein and sealed, foil-laminated sachets containing 300mg of peanut protein. Contents were delivered over an age-appropriate semisolid, vehicle food and mixed thoroughly.
The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase.
|
Placebo
n=48 participants at risk
A Placebo matching the AR101 drug product was supplied in 2 presentations. These were pull-apart capsules matching the 0.5, 1, 10, 20 and 100mg peanut capsules but containing no peanut protein, and sealed, foil-laminated sachets matching the peanut protein sachets but without any peanut protein. Contents were delivered over an age-appropriate semisolid, vehicle food and mixed thoroughly.
The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
53.1%
52/98 • 12 months
|
31.2%
15/48 • 12 months
|
|
Gastrointestinal disorders
Diarrhoea
|
34.7%
34/98 • 12 months
|
27.1%
13/48 • 12 months
|
|
Gastrointestinal disorders
Abdominal pain
|
23.5%
23/98 • 12 months
|
12.5%
6/48 • 12 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
14.3%
14/98 • 12 months
|
8.3%
4/48 • 12 months
|
|
Gastrointestinal disorders
Constipation
|
11.2%
11/98 • 12 months
|
10.4%
5/48 • 12 months
|
|
Gastrointestinal disorders
Oral pruritus
|
10.2%
10/98 • 12 months
|
4.2%
2/48 • 12 months
|
|
Gastrointestinal disorders
Teething
|
10.2%
10/98 • 12 months
|
14.6%
7/48 • 12 months
|
|
Gastrointestinal disorders
Flatulence
|
5.1%
5/98 • 12 months
|
0.00%
0/48 • 12 months
|
|
Gastrointestinal disorders
Lip swelling
|
5.1%
5/98 • 12 months
|
0.00%
0/48 • 12 months
|
|
Gastrointestinal disorders
Nausea
|
5.1%
5/98 • 12 months
|
4.2%
2/48 • 12 months
|
|
Infections and infestations
Upper respiratory tract infection
|
35.7%
35/98 • 12 months
|
27.1%
13/48 • 12 months
|
|
Infections and infestations
Nasopharyngitis
|
28.6%
28/98 • 12 months
|
27.1%
13/48 • 12 months
|
|
Infections and infestations
Rhinitis
|
20.4%
20/98 • 12 months
|
16.7%
8/48 • 12 months
|
|
Infections and infestations
Ear infection
|
11.2%
11/98 • 12 months
|
4.2%
2/48 • 12 months
|
|
Infections and infestations
Gastroenteritis
|
10.2%
10/98 • 12 months
|
12.5%
6/48 • 12 months
|
|
Infections and infestations
Viral infection
|
9.2%
9/98 • 12 months
|
10.4%
5/48 • 12 months
|
|
Infections and infestations
Viral upper respiratory tract infection
|
9.2%
9/98 • 12 months
|
10.4%
5/48 • 12 months
|
|
Infections and infestations
Gastroenteritis viral
|
8.2%
8/98 • 12 months
|
2.1%
1/48 • 12 months
|
|
Infections and infestations
Conjunctivitis
|
6.1%
6/98 • 12 months
|
10.4%
5/48 • 12 months
|
|
Infections and infestations
Corona virus infection
|
6.1%
6/98 • 12 months
|
12.5%
6/48 • 12 months
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
5.1%
5/98 • 12 months
|
4.2%
2/48 • 12 months
|
|
Infections and infestations
Influenza
|
5.1%
5/98 • 12 months
|
0.00%
0/48 • 12 months
|
|
Infections and infestations
Lower respiratory tract infection
|
5.1%
5/98 • 12 months
|
0.00%
0/48 • 12 months
|
|
Infections and infestations
Urinary tract infection
|
5.1%
5/98 • 12 months
|
0.00%
0/48 • 12 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
52.0%
51/98 • 12 months
|
50.0%
24/48 • 12 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
34.7%
34/98 • 12 months
|
35.4%
17/48 • 12 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
27.6%
27/98 • 12 months
|
31.2%
15/48 • 12 months
|
|
Skin and subcutaneous tissue disorders
Eczema
|
24.5%
24/98 • 12 months
|
25.0%
12/48 • 12 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
23.5%
23/98 • 12 months
|
22.9%
11/48 • 12 months
|
|
Skin and subcutaneous tissue disorders
Perioral dermatitis
|
17.3%
17/98 • 12 months
|
8.3%
4/48 • 12 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.2%
8/98 • 12 months
|
4.2%
2/48 • 12 months
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
8.2%
8/98 • 12 months
|
6.2%
3/48 • 12 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
6.1%
6/98 • 12 months
|
10.4%
5/48 • 12 months
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
5.1%
5/98 • 12 months
|
2.1%
1/48 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
53.1%
52/98 • 12 months
|
43.8%
21/48 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
42.9%
42/98 • 12 months
|
31.2%
15/48 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
23.5%
23/98 • 12 months
|
18.8%
9/48 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
14.3%
14/98 • 12 months
|
10.4%
5/48 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
14.3%
14/98 • 12 months
|
8.3%
4/48 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
11.2%
11/98 • 12 months
|
14.6%
7/48 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
8.2%
8/98 • 12 months
|
4.2%
2/48 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.1%
5/98 • 12 months
|
2.1%
1/48 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
5.1%
5/98 • 12 months
|
2.1%
1/48 • 12 months
|
|
General disorders
Pyrexia
|
51.0%
50/98 • 12 months
|
41.7%
20/48 • 12 months
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
7.1%
7/98 • 12 months
|
4.2%
2/48 • 12 months
|
|
Injury, poisoning and procedural complications
Head injury
|
6.1%
6/98 • 12 months
|
2.1%
1/48 • 12 months
|
|
Injury, poisoning and procedural complications
Contusion
|
5.1%
5/98 • 12 months
|
0.00%
0/48 • 12 months
|
|
Eye disorders
Eye pruritus
|
9.2%
9/98 • 12 months
|
10.4%
5/48 • 12 months
|
|
Eye disorders
Eye swelling
|
9.2%
9/98 • 12 months
|
6.2%
3/48 • 12 months
|
|
Eye disorders
Ocular hyperaemia
|
6.1%
6/98 • 12 months
|
4.2%
2/48 • 12 months
|
|
Immune system disorders
Anaphylactic reaction
|
8.2%
8/98 • 12 months
|
8.3%
4/48 • 12 months
|
|
Immune system disorders
Seasonal allergy
|
4.1%
4/98 • 12 months
|
8.3%
4/48 • 12 months
|
|
Nervous system disorders
Headache
|
10.2%
10/98 • 12 months
|
2.1%
1/48 • 12 months
|
|
Psychiatric disorders
Irritability
|
6.1%
6/98 • 12 months
|
2.1%
1/48 • 12 months
|
|
Ear and labyrinth disorders
Ear pain
|
5.1%
5/98 • 12 months
|
6.2%
3/48 • 12 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.1%
5/98 • 12 months
|
0.00%
0/48 • 12 months
|
Additional Information
Director of Regulatory Affairs
Aimmune Therapeutics, Inc.
Phone: 650-409-5164
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee * 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
- Publication restrictions are in place
Restriction type: OTHER