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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003133-15 | EudraCT Number |
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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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The primary objective of the study is to assess the tolerability of peanut protein in pediatric patients (6-17 years old) treated with dupilumab monotherapy, in which tolerability is defined as the proportion of patients who safely pass a double-blind placebo-controlled food challenge (DBPCFC) at week 24.
The secondary objectives are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dupilumab | Experimental | Open label weight base subcutaneous (SC) injection every two (Q2) weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dupilumab | Drug | Dupilumab weight-based dosing will be administered subcutaneously (SC) in a single-use, pre-filled syringe every two weeks (Q2W) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 444 mg (Cumulative) Peanut Protein 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. Percentage of participants treated with dupilumab who passed the DBPCFC with at least 444 mg (cumulative) peanut protein at Week 24 was reported. | At Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Cumulative Tolerated Dose (Log Transformed) of Peanut Protein During a DBPCFC at Weeks 24 and 36 | Change from baseline in cumulative tolerated dose (log transformed) of peanut protein during a DBPCFC at Week 24 and Week 36 was reported. | Weeks 24 and 36 |
| 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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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol Inclusion/Exclusion Criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regeneron Investigational Site | Mountain View | California | 94305 | United States | ||
| Regeneron Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39673367 | Derived | Chinthrajah RS, Sindher SB, Nadeau KC, Leflein JG, Spergel JM, Petroni DH, Jones SM, Casale TB, Wang J, Carr WW, Shreffler WG, Wood RA, Wambre E, Liu J, Akinlade B, Atanasio A, Orengo JM, Hamilton JD, Kamal MA, Hooper AT, Patel K, Laws E, Mannent LP, Adelman DC, Ratnayake A, Radin AR. Dupilumab as an Adjunct to Oral Immunotherapy in Pediatric Patients With Peanut Allergy. Allergy. 2025 Mar;80(3):827-842. doi: 10.1111/all.16420. Epub 2024 Dec 14. | |
| 38814736 |
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All IPD that underlie results in a publication
Individual de-identified participant data will be made available once the indication has been approved by a regulatory body, if there is participant consent and there is not a reasonable likelihood of participant re-identification.
Qualified researchers may request access to study documents (including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan) that support the methods and findings reported in a manuscript. Individual de-identified participant data will be made available once the indication has been approved by a regulatory body, if there is participant consent and there is not a reasonable likelihood of participant re-identification.
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
SAF(all participants who received dupilumab)
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 444 mg (Cumulative) Peanut Protein 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. Percentage of participants treated with dupilumab who passed the DBPCFC with at least 444 mg (cumulative) peanut protein at Week 24 was reported. | The SAF included all participants who received dupilumab. | Posted | Number | 95% Confidence Interval | Percentage of Participants | At Week 24 |
|
Up to the end of study (Week 36)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site erythema | General disorders | MedDRA (23.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Administrator | Regeneron Pharmaceuticals, Inc. | 844-734-6643 | clinicaltrials@regeneron.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 30, 2020 | Feb 16, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 5, 2021 | Apr 1, 2022 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D021183 | Peanut Hypersensitivity |
| ID | Term |
|---|---|
| D000074924 | Nut and Peanut Hypersensitivity |
| D005512 | Food Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
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| ID | Term |
|---|---|
| C582203 | dupilumab |
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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. |
| At Week 36 |
| Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 1044 mg (Cumulative) Peanut Protein 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. Percentage of participants treated with dupilumab who passed a DBPCFC with at least 1044 mg (cumulative) peanut protein at Week 24 was reported. | At Week 24 |
| Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 1044 mg (Cumulative) Peanut Protein at Week 36 | 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. | At Week 36 |
| Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 2044 mg (Cumulative) Peanut Protein 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. Percentage of participants treated with dupilumab who passed a DBPCFC with at least 2044 mg (cumulative) peanut protein at Week 24 was reported. | At Week 24 |
| Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 2044 mg (Cumulative) Peanut Protein at Week 36 | 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. | At Week 36 |
| Percent Change From Baseline in Peanut-specific Immunoglobulin E (sIgE) at Weeks 4, 8, 12, 16, 24, and 36 | Percent change from baseline in sIgE at Weeks 4, 8, 12, 16, 24, and 36 was reported. | Weeks 4, 8, 12, 16, 24, and 36 |
| 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 | 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. | Weeks 4, 12, 24, and 36 |
| Percentage of Participants With Grade 2 or Above Allergic Reactions During the DBPCFC 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. Percentage of participants with Grade 2 (Moderate) or above allergic reactions during the DBPCFC at Week 24 was reported. | At Week 24 |
| Percentage of Participants Who Used Epinephrine as a Rescue Medication During the DBPCFC at Week 24 | Percentage of participants who used Epinephrine as a rescue medication during the DBPCFC at Week 24 was reported. | At Week 24 |
| Tampa |
| Florida |
| 33612 |
| United States |
| Regeneron Investigational Site | Indianapolis | Indiana | 46202 | United States |
| Regeneron Investigational Site | Ypsilanti | Michigan | 48197 | United States |
| Regeneron Investigational Site | Great Neck | New York | 11021 | United States |
| Regeneron Investigational Site | The Bronx | New York | 10461 | United States |
| Regeneron Investigational Site | Hamilton | Ontario | L8S 1G5 | Canada |
| Regeneron Investigational Site | Toronto | Ontario | M5G 1X8 | Canada |
| Regeneron Investigational Site | Montreal | Quebec | H3T 1C5 | Canada |
| Derived |
| Ghelli C, Costanzo G, Canonica GW, Heffler E, Paoletti G. New evidence in food allergies treatment. Curr Opin Allergy Clin Immunol. 2024 Aug 1;24(4):251-256. doi: 10.1097/ACI.0000000000000999. Epub 2024 May 30. |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | Change From Baseline in Cumulative Tolerated Dose (Log Transformed) of Peanut Protein During a DBPCFC at Weeks 24 and 36 | Change from baseline in cumulative tolerated dose (log transformed) of peanut protein during a DBPCFC at Week 24 and Week 36 was reported. | The SAF included all participants who received dupilumab. | Posted | Mean | Standard Deviation | Log Transformed Milligrams | Weeks 24 and 36 |
|
|
|
| Secondary | Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 444 mg (Cumulative) Peanut Protein at Week 36 | 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. | A subset of the SAF that included only participants who passed the DBPCFC of at least 444 mg (cumulative) at Week 24. | Posted | Number | Percentage of Participants | At Week 36 |
|
|
|
| Secondary | Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 1044 mg (Cumulative) Peanut Protein 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. Percentage of participants treated with dupilumab who passed a DBPCFC with at least 1044 mg (cumulative) peanut protein at Week 24 was reported. | The SAF included all participants who received dupilumab. | Posted | Number | 95% Confidence Interval | Percentage of Participants | At Week 24 |
|
|
|
| Secondary | Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 1044 mg (Cumulative) Peanut Protein at Week 36 | 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. | A subset of the SAF that included only participants who passed the DBPCFC of at least 444 mg (cumulative) at Week 24. | Posted | Number | Percentage of Participants | At Week 36 |
|
|
|
| Secondary | Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 2044 mg (Cumulative) Peanut Protein 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. Percentage of participants treated with dupilumab who passed a DBPCFC with at least 2044 mg (cumulative) peanut protein at Week 24 was reported. | The SAF included all participants who received dupilumab. | Posted | Number | 95% Confidence Interval | Percentage of Participants | At Week 24 |
|
|
|
| Secondary | Percentage of Participants Treated With Dupilumab Who Passed a DBPCFC With at Least 2044 mg (Cumulative) Peanut Protein at Week 36 | 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. | A subset of the SAF that included only participants who passed the DBPCFC of at least 444 mg (cumulative) at Week 24. | Posted | Number | Percentage of Participants | At Week 36 |
|
|
|
| Secondary | Percent Change From Baseline in Peanut-specific Immunoglobulin E (sIgE) at Weeks 4, 8, 12, 16, 24, and 36 | Percent change from baseline in sIgE at Weeks 4, 8, 12, 16, 24, and 36 was reported. | The SAF included all participants who received dupilumab. | Posted | Median | Inter-Quartile Range | Percent Change | Weeks 4, 8, 12, 16, 24, and 36 |
|
|
|
| Secondary | 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 | 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. | The SAF included all participants who received dupilumab. | Posted | Mean | Standard Deviation | millimeter (mm) | Weeks 4, 12, 24, and 36 |
|
|
|
| Secondary | Percentage of Participants With Grade 2 or Above Allergic Reactions During the DBPCFC 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. Percentage of participants with Grade 2 (Moderate) or above allergic reactions during the DBPCFC at Week 24 was reported. | The SAF included all participants who received dupilumab. | Posted | Number | Percentage of Participants | At Week 24 |
|
|
|
| Secondary | Percentage of Participants Who Used Epinephrine as a Rescue Medication During the DBPCFC at Week 24 | Percentage of participants who used Epinephrine as a rescue medication during the DBPCFC at Week 24 was reported. | The SAF included all participants who received dupilumab. | Posted | Number | Percentage of Participants | At Week 24 |
|
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | 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. | 0 | 24 | 0 | 24 | 11 | 24 |
| Injection site haemorrhage | General disorders | MedDRA (23.1) | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA (23.1) | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA (23.1) | Systematic Assessment |
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| Injection site urticaria | General disorders | MedDRA (23.1) | Systematic Assessment |
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| Medical device pain | General disorders | MedDRA (23.1) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Systematic Assessment |
|
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.
| D007154 | Immune System Diseases |
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| Percent change at Week 12 |
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| Percent change at Week 16 |
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| Percent change at Week 24 |
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| Percent change at Week 36 |
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| Change at Week 24 |
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| Change at Week 36 |
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