Trial Outcomes & Findings for Study to Evaluate Dupilumab Monotherapy in Pediatric Patients With Peanut Allergy (NCT NCT03793608)
NCT ID: NCT03793608
Last Updated: 2022-05-19
Results Overview
Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Percentage of participants treated with dupilumab who passed the DBPCFC with at least 444 mg (cumulative) peanut protein at Week 24 was reported.
COMPLETED
PHASE2
25 participants
At Week 24
2022-05-19
Participant Flow
Twenty-five participants met eligibility criteria. One of the 25 participants was randomized under the original double-blind placebo-controlled protocol and received placebo-matching dupilumab. Following implementation of Protocol Amendment 1, 24 participants were enrolled under the open-label design \& received open-label treatment with dupilumab.
A double-blind placebo-controlled food challenge (DBPCFC) consisting of increasing amounts of peanut protein up to a cumulative total of 144 mg and a matching placebo challenge consisting of placebo material (oat protein) were given to confirm current peanut allergy. Food challenges were performed on different days in random order (1-day placebo, 1-day peanut protein), at least 24 hours, but not more than 7 days, apart. Both food challenge days were required to evaluate eligibility.
Participant milestones
| Measure |
Placebo
Participant enrolled under original double-blind protocol design randomized to receive placebo matched to dupilumab from Day 1 up to Week 22. At Week 24, all participants underwent a DBPCFC up to 2044 mg peanut protein (cumulative) or placebo to assess tolerability.
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Dupilumab
Participants enrolled under open-label treatment protocol with weight of greater than or equal to (\>=) 20 kilograms (kg) and less than (\<) 60 kg received a subcutaneous (SC) injection of dupilumab 200 mg every 2 weeks (Q2W) after a loading dose of 400 mg on Day 1 up to Week 22; participants with weight of \>=60 kg received a SC injection of dupilumab 300 mg Q2W after a loading dose of 600 mg on Day 1 up to Week 22. At Week 24, all participants underwent a DBPCFC up to 2044 mg peanut protein (cumulative) or placebo to assess tolerability.
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|---|---|---|
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Overall Study
STARTED
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1
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24
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|
Overall Study
Treated
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1
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24
|
|
Overall Study
Safety Analysis Set (SAF)
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0
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24
|
|
Overall Study
COMPLETED
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1
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24
|
|
Overall Study
NOT COMPLETED
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate Dupilumab Monotherapy in Pediatric Patients With Peanut Allergy
Baseline characteristics by cohort
| Measure |
Dupilumab
n=24 Participants
Participants enrolled under open-label treatment protocol with weight of greater than or equal to (\>=) 20 kilograms (kg) and less than (\<) 60 kg received a subcutaneous (SC) injection of dupilumab 200 mg every 2 weeks (Q2W) after a loading dose of 400 mg on Day 1 up to Week 22; participants with weight of \>=60 kg received a SC injection of dupilumab 300 mg Q2W after a loading dose of 600 mg on Day 1 up to Week 22. At Week 24, all participants underwent a DBPCFC up to 2044 mg peanut protein (cumulative) or placebo to assess tolerability.
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|---|---|
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Age, Continuous
|
11.7 Years
STANDARD_DEVIATION 3.28 • n=5 Participants
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Sex: Female, Male
Female
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6 Participants
n=5 Participants
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Sex: Female, Male
Male
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18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
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3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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|
Race (NIH/OMB)
Black or African American
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1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Week 24Population: The SAF included all participants who received dupilumab.
Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Percentage of participants treated with dupilumab who passed the DBPCFC with at least 444 mg (cumulative) peanut protein at Week 24 was reported.
Outcome measures
| Measure |
Dupilumab
n=24 Participants
Participants enrolled under open-label treatment protocol with weight of greater than or equal to (\>=) 20 kilograms (kg) and less than (\<) 60 kg received a subcutaneous (SC) injection of dupilumab 200 mg every 2 weeks (Q2W) after a loading dose of 400 mg on Day 1 up to Week 22; participants with weight of \>=60 kg received a SC injection of dupilumab 300 mg Q2W after a loading dose of 600 mg on Day 1 up to Week 22. At Week 24, all participants underwent a DBPCFC up to 2044 mg peanut protein (cumulative) or placebo to assess tolerability.
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|---|---|
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Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 444 mg (Cumulative) Peanut Protein at Week 24
|
8.3 Percentage of Participants
Interval 1.03 to 27.0
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SECONDARY outcome
Timeframe: Weeks 24 and 36Population: The SAF included all participants who received dupilumab.
Change from baseline in cumulative tolerated dose (log transformed) of peanut protein during a DBPCFC at Week 24 and Week 36 was reported.
Outcome measures
| Measure |
Dupilumab
n=24 Participants
Participants enrolled under open-label treatment protocol with weight of greater than or equal to (\>=) 20 kilograms (kg) and less than (\<) 60 kg received a subcutaneous (SC) injection of dupilumab 200 mg every 2 weeks (Q2W) after a loading dose of 400 mg on Day 1 up to Week 22; participants with weight of \>=60 kg received a SC injection of dupilumab 300 mg Q2W after a loading dose of 600 mg on Day 1 up to Week 22. At Week 24, all participants underwent a DBPCFC up to 2044 mg peanut protein (cumulative) or placebo to assess tolerability.
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|---|---|
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Change From Baseline in Cumulative Tolerated Dose (Log Transformed) of Peanut Protein During a DBPCFC at Weeks 24 and 36
Change at Week 24
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0.69 Log Transformed Milligrams
Standard Deviation 1.822
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Change From Baseline in Cumulative Tolerated Dose (Log Transformed) of Peanut Protein During a DBPCFC at Weeks 24 and 36
Change at Week 36
|
3.38 Log Transformed Milligrams
Standard Deviation 3.096
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SECONDARY outcome
Timeframe: At Week 36Population: A subset of the SAF that included only participants who passed the DBPCFC of at least 444 mg (cumulative) at Week 24.
Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Only participants treated with dupilumab who passed at least 444 mg (cumulative) peanut challenge at Week 24 were eligible for Week 36 DBFC.
Outcome measures
| Measure |
Dupilumab
n=2 Participants
Participants enrolled under open-label treatment protocol with weight of greater than or equal to (\>=) 20 kilograms (kg) and less than (\<) 60 kg received a subcutaneous (SC) injection of dupilumab 200 mg every 2 weeks (Q2W) after a loading dose of 400 mg on Day 1 up to Week 22; participants with weight of \>=60 kg received a SC injection of dupilumab 300 mg Q2W after a loading dose of 600 mg on Day 1 up to Week 22. At Week 24, all participants underwent a DBPCFC up to 2044 mg peanut protein (cumulative) or placebo to assess tolerability.
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|---|---|
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Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 444 mg (Cumulative) Peanut Protein at Week 36
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50.0 Percentage of Participants
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SECONDARY outcome
Timeframe: At Week 24Population: The SAF included all participants who received dupilumab.
Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Percentage of participants treated with dupilumab who passed a DBPCFC with at least 1044 mg (cumulative) peanut protein at Week 24 was reported.
Outcome measures
| Measure |
Dupilumab
n=24 Participants
Participants enrolled under open-label treatment protocol with weight of greater than or equal to (\>=) 20 kilograms (kg) and less than (\<) 60 kg received a subcutaneous (SC) injection of dupilumab 200 mg every 2 weeks (Q2W) after a loading dose of 400 mg on Day 1 up to Week 22; participants with weight of \>=60 kg received a SC injection of dupilumab 300 mg Q2W after a loading dose of 600 mg on Day 1 up to Week 22. At Week 24, all participants underwent a DBPCFC up to 2044 mg peanut protein (cumulative) or placebo to assess tolerability.
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|---|---|
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Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 1044 mg (Cumulative) Peanut Protein at Week 24
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0.0 Percentage of Participants
Interval 0.0 to 14.25
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SECONDARY outcome
Timeframe: At Week 36Population: A subset of the SAF that included only participants who passed the DBPCFC of at least 444 mg (cumulative) at Week 24.
Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Only participants treated with dupilumab who passed at least 444 mg (cumulative) peanut challenge at Week 24 were eligible for Week 36 DBFC.
Outcome measures
| Measure |
Dupilumab
n=2 Participants
Participants enrolled under open-label treatment protocol with weight of greater than or equal to (\>=) 20 kilograms (kg) and less than (\<) 60 kg received a subcutaneous (SC) injection of dupilumab 200 mg every 2 weeks (Q2W) after a loading dose of 400 mg on Day 1 up to Week 22; participants with weight of \>=60 kg received a SC injection of dupilumab 300 mg Q2W after a loading dose of 600 mg on Day 1 up to Week 22. At Week 24, all participants underwent a DBPCFC up to 2044 mg peanut protein (cumulative) or placebo to assess tolerability.
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|---|---|
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Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 1044 mg (Cumulative) Peanut Protein at Week 36
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50.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: At Week 24Population: The SAF included all participants who received dupilumab.
Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Percentage of participants treated with dupilumab who passed a DBPCFC with at least 2044 mg (cumulative) peanut protein at Week 24 was reported.
Outcome measures
| Measure |
Dupilumab
n=24 Participants
Participants enrolled under open-label treatment protocol with weight of greater than or equal to (\>=) 20 kilograms (kg) and less than (\<) 60 kg received a subcutaneous (SC) injection of dupilumab 200 mg every 2 weeks (Q2W) after a loading dose of 400 mg on Day 1 up to Week 22; participants with weight of \>=60 kg received a SC injection of dupilumab 300 mg Q2W after a loading dose of 600 mg on Day 1 up to Week 22. At Week 24, all participants underwent a DBPCFC up to 2044 mg peanut protein (cumulative) or placebo to assess tolerability.
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|---|---|
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Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 2044 mg (Cumulative) Peanut Protein at Week 24
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0.0 Percentage of Participants
Interval 0.0 to 14.25
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SECONDARY outcome
Timeframe: At Week 36Population: A subset of the SAF that included only participants who passed the DBPCFC of at least 444 mg (cumulative) at Week 24.
Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Only participants treated with dupilumab who passed at least 444 mg (cumulative) peanut challenge at Week 24 were eligible for Week 36 DBFC.
Outcome measures
| Measure |
Dupilumab
n=2 Participants
Participants enrolled under open-label treatment protocol with weight of greater than or equal to (\>=) 20 kilograms (kg) and less than (\<) 60 kg received a subcutaneous (SC) injection of dupilumab 200 mg every 2 weeks (Q2W) after a loading dose of 400 mg on Day 1 up to Week 22; participants with weight of \>=60 kg received a SC injection of dupilumab 300 mg Q2W after a loading dose of 600 mg on Day 1 up to Week 22. At Week 24, all participants underwent a DBPCFC up to 2044 mg peanut protein (cumulative) or placebo to assess tolerability.
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|---|---|
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Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 2044 mg (Cumulative) Peanut Protein at Week 36
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0.0 Percentage of Participants
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SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 24, and 36Population: The SAF included all participants who received dupilumab.
Percent change from baseline in sIgE at Weeks 4, 8, 12, 16, 24, and 36 was reported.
Outcome measures
| Measure |
Dupilumab
n=24 Participants
Participants enrolled under open-label treatment protocol with weight of greater than or equal to (\>=) 20 kilograms (kg) and less than (\<) 60 kg received a subcutaneous (SC) injection of dupilumab 200 mg every 2 weeks (Q2W) after a loading dose of 400 mg on Day 1 up to Week 22; participants with weight of \>=60 kg received a SC injection of dupilumab 300 mg Q2W after a loading dose of 600 mg on Day 1 up to Week 22. At Week 24, all participants underwent a DBPCFC up to 2044 mg peanut protein (cumulative) or placebo to assess tolerability.
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Percent Change From Baseline in Peanut-specific Immunoglobulin E (sIgE) at Weeks 4, 8, 12, 16, 24, and 36
Percent change at Week 4
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-7.86 Percent Change
Interval -19.75 to -1.62
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Percent Change From Baseline in Peanut-specific Immunoglobulin E (sIgE) at Weeks 4, 8, 12, 16, 24, and 36
Percent change at Week 8
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-21.03 Percent Change
Interval -33.45 to -10.37
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Percent Change From Baseline in Peanut-specific Immunoglobulin E (sIgE) at Weeks 4, 8, 12, 16, 24, and 36
Percent change at Week 12
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-32.10 Percent Change
Interval -40.92 to -11.14
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Percent Change From Baseline in Peanut-specific Immunoglobulin E (sIgE) at Weeks 4, 8, 12, 16, 24, and 36
Percent change at Week 16
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-32.22 Percent Change
Interval -47.75 to -16.17
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Percent Change From Baseline in Peanut-specific Immunoglobulin E (sIgE) at Weeks 4, 8, 12, 16, 24, and 36
Percent change at Week 24
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-49.25 Percent Change
Interval -61.22 to -31.85
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Percent Change From Baseline in Peanut-specific Immunoglobulin E (sIgE) at Weeks 4, 8, 12, 16, 24, and 36
Percent change at Week 36
|
-58.43 Percent Change
Interval -71.25 to -45.17
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SECONDARY outcome
Timeframe: Weeks 4, 12, 24, and 36Population: The SAF included all participants who received dupilumab.
The titrated SPT is the skin testing for atopic response at different concentrations of peanut extract with saline as negative control and histamine as positive controls. Wheal size induced by peanut extract at each concentration was calculated as average of largest diameter and perpendicular midpoint diameter. The AUC for titrated SPT was calculated using the mean wheal diameter versus the concentration at which the wheal diameter was measured, which was then normalized to concentration. Change from baseline in titrated SPT as measured by average wheal size AUC after peanut allergen stimulation at different concentrations at Weeks 4, 12, 24, and 36 was reported.
Outcome measures
| Measure |
Dupilumab
n=24 Participants
Participants enrolled under open-label treatment protocol with weight of greater than or equal to (\>=) 20 kilograms (kg) and less than (\<) 60 kg received a subcutaneous (SC) injection of dupilumab 200 mg every 2 weeks (Q2W) after a loading dose of 400 mg on Day 1 up to Week 22; participants with weight of \>=60 kg received a SC injection of dupilumab 300 mg Q2W after a loading dose of 600 mg on Day 1 up to Week 22. At Week 24, all participants underwent a DBPCFC up to 2044 mg peanut protein (cumulative) or placebo to assess tolerability.
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|---|---|
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Change From Baseline in Titrated Skin Prick Test (SPT) Measured by Average Wheal Size Area Under the Curve (AUC) After Peanut Allergen Stimulation at Different Concentrations at Weeks 4, 12, 24, and 36
Change at Week 4
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-0.633 millimeter (mm)
Standard Deviation 2.0604
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Change From Baseline in Titrated Skin Prick Test (SPT) Measured by Average Wheal Size Area Under the Curve (AUC) After Peanut Allergen Stimulation at Different Concentrations at Weeks 4, 12, 24, and 36
Change at Week 12
|
-0.174 millimeter (mm)
Standard Deviation 2.0618
|
|
Change From Baseline in Titrated Skin Prick Test (SPT) Measured by Average Wheal Size Area Under the Curve (AUC) After Peanut Allergen Stimulation at Different Concentrations at Weeks 4, 12, 24, and 36
Change at Week 24
|
-0.232 millimeter (mm)
Standard Deviation 2.0610
|
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Change From Baseline in Titrated Skin Prick Test (SPT) Measured by Average Wheal Size Area Under the Curve (AUC) After Peanut Allergen Stimulation at Different Concentrations at Weeks 4, 12, 24, and 36
Change at Week 36
|
-0.364 millimeter (mm)
Standard Deviation 2.1419
|
SECONDARY outcome
Timeframe: At Week 24Population: The SAF included all participants who received dupilumab.
Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction. Percentage of participants with Grade 2 (Moderate) or above allergic reactions during the DBPCFC at Week 24 was reported.
Outcome measures
| Measure |
Dupilumab
n=24 Participants
Participants enrolled under open-label treatment protocol with weight of greater than or equal to (\>=) 20 kilograms (kg) and less than (\<) 60 kg received a subcutaneous (SC) injection of dupilumab 200 mg every 2 weeks (Q2W) after a loading dose of 400 mg on Day 1 up to Week 22; participants with weight of \>=60 kg received a SC injection of dupilumab 300 mg Q2W after a loading dose of 600 mg on Day 1 up to Week 22. At Week 24, all participants underwent a DBPCFC up to 2044 mg peanut protein (cumulative) or placebo to assess tolerability.
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|---|---|
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Percentage of Participants With Grade 2 or Above Allergic Reactions During the DBPCFC at Week 24
|
33.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: At Week 24Population: The SAF included all participants who received dupilumab.
Percentage of participants who used Epinephrine as a rescue medication during the DBPCFC at Week 24 was reported.
Outcome measures
| Measure |
Dupilumab
n=24 Participants
Participants enrolled under open-label treatment protocol with weight of greater than or equal to (\>=) 20 kilograms (kg) and less than (\<) 60 kg received a subcutaneous (SC) injection of dupilumab 200 mg every 2 weeks (Q2W) after a loading dose of 400 mg on Day 1 up to Week 22; participants with weight of \>=60 kg received a SC injection of dupilumab 300 mg Q2W after a loading dose of 600 mg on Day 1 up to Week 22. At Week 24, all participants underwent a DBPCFC up to 2044 mg peanut protein (cumulative) or placebo to assess tolerability.
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|---|---|
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Percentage of Participants Who Used Epinephrine as a Rescue Medication During the DBPCFC at Week 24
|
41.7 Percentage of Participants
|
Adverse Events
Placebo
Dupilumab
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=1 participants at risk
Participant enrolled under original double-blind protocol design randomized to receive placebo matched to dupilumab from Day 1 up to Week 22. At Week 24, all participants underwent a DBPCFC up to 2044 mg peanut protein (cumulative) or placebo to assess tolerability.
|
Dupilumab
n=24 participants at risk
Participants enrolled under open-label treatment protocol with weight of greater than or equal to (\>=) 20 kilograms (kg) and less than (\<) 60 kg received a subcutaneous (SC) injection of dupilumab 200 mg every 2 weeks (Q2W) after a loading dose of 400 mg on Day 1 up to Week 22; participants with weight of \>=60 kg received a SC injection of dupilumab 300 mg Q2W after a loading dose of 600 mg on Day 1 up to Week 22. At Week 24, all participants underwent a DBPCFC up to 2044 mg peanut protein (cumulative) or placebo to assess tolerability.
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|---|---|---|
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General disorders
Injection site erythema
|
0.00%
0/1 • Up to the end of study (Week 36)
|
8.3%
2/24 • Number of events 2 • Up to the end of study (Week 36)
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/1 • Up to the end of study (Week 36)
|
8.3%
2/24 • Number of events 3 • Up to the end of study (Week 36)
|
|
General disorders
Injection site pain
|
0.00%
0/1 • Up to the end of study (Week 36)
|
12.5%
3/24 • Number of events 4 • Up to the end of study (Week 36)
|
|
General disorders
Injection site reaction
|
0.00%
0/1 • Up to the end of study (Week 36)
|
8.3%
2/24 • Number of events 4 • Up to the end of study (Week 36)
|
|
General disorders
Injection site urticaria
|
0.00%
0/1 • Up to the end of study (Week 36)
|
12.5%
3/24 • Number of events 5 • Up to the end of study (Week 36)
|
|
General disorders
Medical device pain
|
0.00%
0/1 • Up to the end of study (Week 36)
|
8.3%
2/24 • Number of events 2 • Up to the end of study (Week 36)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/1 • Up to the end of study (Week 36)
|
8.3%
2/24 • Number of events 2 • Up to the end of study (Week 36)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/1 • Up to the end of study (Week 36)
|
8.3%
2/24 • Number of events 2 • Up to the end of study (Week 36)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1 • Up to the end of study (Week 36)
|
8.3%
2/24 • Number of events 2 • Up to the end of study (Week 36)
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Up to the end of study (Week 36)
|
12.5%
3/24 • Number of events 8 • Up to the end of study (Week 36)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/1 • Up to the end of study (Week 36)
|
8.3%
2/24 • Number of events 4 • Up to the end of study (Week 36)
|
Additional Information
Clinical Trials Administrator
Regeneron Pharmaceuticals, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER