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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-001544-64 | EudraCT Number |
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Lack of efficacy
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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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The primary objective of the study is to assess the efficacy of REGN3500 monotherapy in Atopic dermatitis (AD), as well as understand the dose-response relationship, compared with placebo treatment, in adult patients with moderate-to-severe AD.
Secondary objectives are to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment 1 | Experimental |
| |
| Treatment 2 | Experimental |
| |
| Treatment 3 | Experimental |
| |
| Treatment 4 | Experimental |
| |
| Treatment 5 | Experimental | Matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN3500 | Drug | Administered subcutaneous (SC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percent change from baseline in EASI score at Week 16 was reported. Values after first rescue treatment were set to missing. | Week 16 |
| Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on All Observed Values Regardless of Rescue Treatment at Week 16 | The EASI score was used to measure the severity and extent of AD and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percent change from baseline in EASI score at Week 16 based on all observed values regardless of rescue treatment was reported. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Eczema Area and Severity Index-50 (EASI-50) (Greater Than or Equal to [≥] 50 Percent [%] Improvement From Baseline) Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percentage of participants who achieved EASI-50 (≥50% Improvement from baseline) at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing EASI score at Week 16 were counted as non-responders. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Participation in a prior anti-Interleukin (IL)-33 medication clinical study
Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit
Having used any of the following treatments within 4 weeks before the baseline visit or any condition that, in the opinion of the investigator, is likely to require such treatment(s) during the first 4 weeks of study treatment:
Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the baseline visit
Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit
Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit
Known or suspected history of immunosuppression
History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening
Positive with hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C virus antibody (HCV Ab) at the screening visit
Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study
Note: Other protocol defined 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 Study Site | Birmingham | Alabama | 35209 | United States | ||
| Regeneron Study Site |
Participants were randomized in 1:1:1:1:1 ratio to 1 of the 5 treatment groups: Placebo every 2 weeks (Q2W); REGN3500 30 milligrams (mg) every 8 weeks (Q8W); REGN3500 100 mg every 4 weeks (Q4W); REGN3500 300 mg Q4W and REGN3500 300 mg Q2W.
A total of 238 participants were screened at centers in North America (United States of America and Canada), Europe (Czech Republic, Germany, Hungary, Spain, and Poland), and Asia Pacific (Republic of Korea, Japan, and Australia). Out of which, 129 participants were randomized in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Q2W | Participants received 3 subcutaneous (SC) injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14. |
| FG001 | REGN3500 30 mg Q8W |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Jan 3, 2019 | Dec 15, 2021 |
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| REGN3500-Matching Placebo | Drug | Administered subcutaneous (SC) |
|
| Week 16 |
| Percentage of Participants Who Achieved Eczema Area and Severity Index-50 (EASI-50) (Greater Than or Equal to [≥] 50% Improvement From Baseline) Based on All Observed Values Regardless of Rescue Treatment at Week 16 | The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percentage of participants who achieved EASI-50 (≥50% Improvement from baseline) at Week 16 were based on all observed values regardless of rescue treatment were reported. | Week 16 |
| Percentage of Participants Who Achieved Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percentage of participants who achieved EASI-75 (≥75% Improvement from baseline) at Week 16 based on observed values set to missing after rescue treatment were reported. Values after first rescue treatment were set to missing and participants with missing EASI score at Week 16 were counted as non-responders. | Week 16 |
| Percentage of Participants Who Achieved Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) Based on All Observed Values Regardless of Rescue Treatment at Week 16 | The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percentage of participants who achieved EASI-75 (≥75% Improvement from baseline) at Week 16 based on all observed values regardless of rescue treatment were reported. | Week 16 |
| Percentage of Participants Who Achieved Eczema Area and Severity Index-90 (EASI-90) (≥90% Improvement From Baseline) Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percentage of participants who achieved EASI-90 (≥90% Improvement from baseline) at Week 16 based on observed values set to missing after rescue treatment were reported. Values after first rescue treatment were set to missing and participants with missing EASI score at Week 16 were counted as non-responders. | Week 16 |
| Percentage of Participants Who Achieved Eczema Area and Severity Index-90 (EASI-90) (≥90% Improvement From Baseline) Based on All Observed Values Regardless of Rescue Treatment at Week 16 | The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percentage of participants who achieved EASI-90 (≥90% Improvement from baseline) at Week 16 based on all observed values regardless of rescue treatment were reported. | Week 16 |
| Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | The EASI score was used to measure the severity and extent of AD and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Absolute change from baseline in EASI score at Week 16 based on observed values set to missing after rescue treatment was reported. | Week 16 |
| Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on All Observed Values Regardless of Rescue Treatment at Week 16 | The EASI score was used to measure the severity and extent of AD and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Absolute change from baseline in EASI score at Week 16 based on all observed values regardless of rescue treatment was reported. | Week 16 |
| Percentage of Participants With Both Investigator Global Assessment (IGA) Score 0 or 1 (on 0 to 5 IGA Scale) and a Reduction From Baseline of ≥2 Points Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | IGA was an assessment scale used to determine severity of AD and clinical response to treatment on a 5 point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). Participants with both IGA score of "0" or "1" and a reduction from baseline of ≥2 points at Week 16 based on observed values set to missing after rescue treatment were reported. Values after first rescue treatment were set to missing and participants with missing IGA score at Week 16 were counted as non-responders. | Week 16 |
| Percentage of Participants With Both IGA Score 0 or 1 (on the 0 to 5 IGA Scale) and a Reduction From Baseline of ≥2 Points Based on All Observed Values Regardless of Rescue Treatment at Week 16 | IGA was an assessment scale used to determine severity of AD and clinical response to treatment on a 5 point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). Participants with both IGA score of "0" or "1" and a reduction from baseline of ≥2 points at Week 16 based on all observed values regardless of rescue treatment were reported. | Week 16 |
| Absolute Change From Baseline in Weekly Average of Daily Peak Pruritus Numerical Rating Scale (NRS) Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Absolute change from baseline in weekly average of daily Peak Pruritus NRS score at Week 16 based on observed values set to missing after rescue treatment was reported. | Week 16 |
| Absolute Change From Baseline in Weekly Average of Daily Peak Pruritus NRS Score Based on All Observed Values Regardless of Rescue Treatment at Week 16 | Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Absolute Change From Baseline in Weekly Average of Daily Peak Pruritus NRS Score Based on All Observed Values Regardless of Rescue Treatment at Week 16 | Week 16 |
| Percent Change From Baseline in Weekly Average of Daily Peak Pruritus NRS Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Percent change from baseline in weekly average of daily peak pruritus NRS score at Week 16 based on observed values set to missing after rescue treatment was reported. Values after first rescue treatment were set to missing and participants with missing NRS score at Week 16 were counted as non-responders. | Week 16 |
| Percent Change From Baseline in Weekly Average of Daily Peak Pruritus NRS Score Based on All Observed Values Regardless of Rescue Treatment at Week 16 | Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Percent change from baseline in weekly average of daily peak pruritus NRS score at Week 16 based on all observed values regardless of rescue treatment was reported. | Week 16 |
| Percentage of Participants With Improvement (Reduction From Baseline) in Weekly Average of Peak Daily Pruritus NRS Score ≥4 Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Percentage of participants with improvement of weekly average of daily peak pruritus NRS score ≥4 from baseline to Week 16 based on observed values set to missing after rescue treatment were reported. Values after first rescue treatment were set to missing and participants with missing NRS score at Week 16 were counted as non-responders. | Week 16 |
| Percentage of Participants With Improvement (Reduction From Baseline) in Weekly Average of Daily Peak Pruritus NRS Score ≥4 Based on All Observed Values Regardless of Rescue Treatment at Week 16 | Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Percentage of participants with improvement of weekly average of daily peak pruritus NRS score ≥4 from baseline to Week 16 based on all observed values regardless of rescue treatment were reported. | Week 16 |
| Time to Onset of Effect on Pruritus (≥4-point Reduction of Weekly Average of Daily Peak Pruritus NRS From Baseline) | Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period. Participants were asked the following question: For maximum itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours?" | Week 16 |
| Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 16 | The SCORAD index is a clinical tool for assessing the severity of atopic dermatitis (AD). Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease). | Week 16 |
| Absolute Change From Baseline in Percent Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement at Week 16 | BSA affected by AD will be assessed for each section of the body using the rule of nines (the possible highest score for each region is: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]) and will be reported as a percentage of all major body sections combined. The proportion assigned to different body regions is different in younger children as compared to older children (head and neck area is assigned a higher proportion in younger children as compared to older children). | Week 16 |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) up to Week 16 | Adverse Event (AE): any untoward medical occurrence in a participant administered a study drug which may/may not have a causal relationship with study drug. Serious AE (SAE): any untoward medical occurrence that resulted in any of following outcomes: death, life-threatening, required initial/prolonged in-participant hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect/considered as medically important event. TEAE: AEs starting/worsening after first intake of study drug. TEAEs included: serious TEAEs and Non-serious TEAEs. AESI included: Anaphylactic or acute allergic reactions; Severe injection site reactions; Mycosis fungoides/other forms of cutaneous T-cell lymphoma; severe infections; any clinical endoparasitosis; Conjunctivitis, keratitis, or blepharitis; significant Alanine aminotransferase (ALT) elevation. Number of participants with TEAEs, Serious TEAES and AESIs from baseline up to Week 16 were reported. | Up to week 16 |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) up to Week 36 | AE: any untoward medical occurrence in a participant administered a study drug which may/may not have a causal relationship with study drug. SAE: any untoward medical occurrence that resulted in any of following outcomes: death, life-threatening, required initial/prolonged in-participant hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect/considered as medically important event. TEAE: AEs starting/worsening after first intake of study drug. TEAEs included both Serious TEAEs and Non-serious TEAEs. AESI included: Anaphylactic or acute allergic reactions; Severe injection site reactions; Mycosis fungoides/other forms of cutaneous T-cell lymphoma; severe infections; any clinical endoparasitosis; Conjunctivitis, keratitis, or blepharitis; significant Alanine aminotransferase (ALT) elevation. Number of participants with TEAEs, Serious TEAES and AESIs from baseline up to Week 36 were reported. | Up to week 36 |
| Serum Concentration of Functional REGN3500 | Serum Concentration of Functional REGN3500 was reported. | Baseline (Week 0), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32 and 36 |
| Number of Participants With Positive Treatment-Emergent Anti-REGN3500 Antibodies (ADA) | Treatment-Emergent (TE) ADA was defined as any positive post baseline assay response when baseline results were negative or missing. Treatment-Emergent ADA responses were further classified as: - persistent (treatment-emergent positive ADA response detected in at least 2 consecutive post baseline samples separated by at least a 16-week post baseline period [based on nominal sampling time], with no ADA-negative samples in-between, regardless of any missing samples or a positive response at the last ADA sampling time point),- indeterminate (a positive assay response at the last collection time point only, regardless of any missing samples), - transient (not persistent/indeterminate, regardless of any missing samples). Number of participants with positive treatment-emergent anti-REGN3500 antibodies (ADA) were reported. Here, "Number of Participants Analyzed" signifies those participants who were evaluable for this endpoint. | Up to week 36 |
| Phoenix |
| Arizona |
| 85006 |
| United States |
| Regeneron Study Site | Scottsdale | Arizona | 85259 | United States |
| Regeneron Study Site | Tucson | Arizona | 85718 | United States |
| Regeneron Study Site | Little Rock | Arkansas | 72205 | United States |
| Regeneron Study Site | Fountain Valley | California | 92708 | United States |
| Regeneron Study Site | Fremont | California | 94538 | United States |
| Regeneron Study Site | Oceanside | California | 92056 | United States |
| Regeneron Study Site | Sacramento | California | 95815 | United States |
| Regeneron Study Site | Santa Monica | California | 90404 | United States |
| Regeneron Study Site | Jacksonville | Florida | 32256 | United States |
| Regeneron Study Site | Macon | Georgia | 31217 | United States |
| Regeneron Study Site | Skokie | Illinois | 60077 | United States |
| Regeneron Study Site | Evansville | Indiana | 47714 | United States |
| Regeneron Study Site | Overland Park | Kansas | 66215 | United States |
| Regeneron Study Site | Louisville | Kentucky | 40202 | United States |
| Regeneron Study Site | Louisville | Kentucky | 40217 | United States |
| Regeneron Study Site | Louisville | Kentucky | 40241 | United States |
| Regeneron Study Site | Saint Joseph | Michigan | 49085 | United States |
| Regeneron Study Site | Minneapolis | Minnesota | 55402 | United States |
| Regeneron Study Site | Las Vegas | Nevada | 89148 | United States |
| Regeneron Study Site | Lebanon | New Hampshire | 03756 | United States |
| Regeneron Study Site | New York | New York | 10022 | United States |
| Regeneron Study Site | Wilmington | North Carolina | 28405 | United States |
| Regeneron Study Site | Cincinnati | Ohio | 45231 | United States |
| Regeneron Study Site | Norman | Oklahoma | 73071 | United States |
| Regeneron Study Site | North Charleston | South Carolina | 29420 | United States |
| Regeneron Study Site | San Antonio | Texas | 78218 | United States |
| Regeneron Study Site | San Antonio | Texas | 78229 | United States |
| Regeneron Study Site | San Antonio | Texas | 78258 | United States |
| Regeneron Study Site | Norfolk | Virginia | 23502 | United States |
| Regeneron Study Site | Kogarah | 2217 | Australia |
| Regeneron Study Site | Melbourne | 3002 | Australia |
| Regeneron Study Site | Calgary | Alberta | T2G 1B1 | Canada |
| Regeneron Study Site | Hamilton | Ontario | L8S 1G5 | Canada |
| Regeneron Study Site | Hamilton | Ontario | L8S 4K1 | Canada |
| Regeneron Study Site | Toronto | Ontario | M5N 1E3 | Canada |
| Regeneron Study Site | Windsor | Ontario | N8X 2G1 | Canada |
| Regeneron Study Site | Verdun | Quebec | H4G 3E7 | Canada |
| Regeneron Study Site | Brno | 602 00 | Czechia |
| Regeneron Study Site | Náchod | 547 01 | Czechia |
| Regeneron Study Site | Ostrava | 702 00 | Czechia |
| Regeneron Study Site | Prague | 130 00 | Czechia |
| Regeneron Study Site | Bad Bentheim | 48455 | Germany |
| Regeneron Study Site | Berlin | 10117 | Germany |
| Regeneron Study Site | Berlin | 12459 | Germany |
| Regeneron Study Site | Frankfurt | 60590 | Germany |
| Regeneron Study Site | Hamburg | 20537 | Germany |
| Regeneron Study Site | Hanau | 63450 | Germany |
| Regeneron Study Site | Ibbenbueren | 49477 | Germany |
| Regeneron Study Site | Leipzig | 04103 | Germany |
| Regeneron Study Site | Lübeck | 23538 | Germany |
| Regeneron Study Site | München | 80337 | Germany |
| Regeneron Study Site | Münster | 48149 | Germany |
| Regeneron Study Site | Tübingen | 72076 | Germany |
| Regeneron Study Site | Witten | 58453 | Germany |
| Regeneron Study Site | Orosháza | Bekes County | 5900 | Hungary |
| Regeneron Study Site | Debrecen | Hajdú-Bihar | 4032 | Hungary |
| Regeneron Study Site | Budapest | 84-88 | Hungary |
| Regeneron Study Site | Chūō | 409-3898 | Japan |
| Regeneron Study Site | Hiroshima | 734-8551 | Japan |
| Regeneron Study Site | Kanagawa | 252-0392 | Japan |
| Regeneron Study Site | Kyoto | 602-8566 | Japan |
| Regeneron Study Site | Kyoto | 606-8507 | Japan |
| Regeneron Study Site | Shizuoka | 420-8630 | Japan |
| Regeneron Study Site | Shizuoka | 430-0929 | Japan |
| Regeneron Study Site | Wakayama | 641-8510 | Japan |
| Regeneron Study Site | Yamanashi | 400-8506 | Japan |
| Regeneron Study Site | Krakow | 30-033 | Poland |
| Regeneron Study Site | Lodz | 90-436 | Poland |
| Regeneron Study Site | Szczecin | 71-434 | Poland |
| Regeneron Study Site | Warsaw | 01-817 | Poland |
| Regeneron Study Site | Warsaw | 02-953 | Poland |
| Regeneron Study Site | Wroclaw | 51-318 | Poland |
| Regeneron Study Site | Wroclaw | 51-685 | Poland |
| Regeneron Study Site | Bucheon-si | 14584 | South Korea |
| Regeneron Study Site | Busan | 49241 | South Korea |
| Regeneron Study Site | Gyeonggi-do | 16499 | South Korea |
| Regeneron Study Site | Incheon | 21431 | South Korea |
| Regeneron Study Site | Incheon | 21565 | South Korea |
| Regeneron Study Site | Seoul | 02841 | South Korea |
| Regeneron Study Site | Seoul | 06591 | South Korea |
| Regeneron Study Site | Seoul | 06973 | South Korea |
| Regeneron Study Site | Seoul | 07441 | South Korea |
| Regeneron Study Site | Barakaldo | 48903 | Spain |
| Regeneron Study Site | Córdoba | 14004 | Spain |
| Regeneron Study Site | Madrid | 28041 | Spain |
| Regeneron Study Site | Santiago de Compostela | 15706 | Spain |
| Regeneron Study Site | Sheffield | S10 2JF | United Kingdom |
Participants received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
| FG002 | REGN3500 100 mg Q4W | Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. |
| FG003 | REGN3500 300 mg Q4W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. |
| FG004 | REGN3500 300 mg Q2W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14. |
| Treated |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
Full Analysis Set (FAS) included all randomized participants and was based on the treatment allocated (as randomized).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Q2W | Participants received 3 subcutaneous (SC) injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14. |
| BG001 | REGN3500 30 mg Q8W | Participants received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14. |
| BG002 | REGN3500 100 mg Q4W | Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. |
| BG003 | REGN3500 300 mg Q4W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. |
| BG004 | REGN3500 300 mg Q2W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Eczema Area and Severity Index (EASI) Score | The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. FAS included all randomized participants and was based on the treatment allocated (as randomized). | Here, "Number Analyzed" signifies those participants who were evaluable for this baseline characteristic. | Mean | Standard Deviation | Scores on a scale |
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| 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 | ||||||||||||||||||||||||||||||||
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| Primary | Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percent change from baseline in EASI score at Week 16 was reported. Values after first rescue treatment were set to missing. | FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed. | Posted | Mean | Standard Deviation | Percentage of change | Week 16 |
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| Primary | Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on All Observed Values Regardless of Rescue Treatment at Week 16 | The EASI score was used to measure the severity and extent of AD and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percent change from baseline in EASI score at Week 16 based on all observed values regardless of rescue treatment was reported. | FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed. | Posted | Mean | Standard Deviation | Percentage of change | Week 16 |
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| Secondary | Percentage of Participants Who Achieved Eczema Area and Severity Index-50 (EASI-50) (Greater Than or Equal to [≥] 50 Percent [%] Improvement From Baseline) Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percentage of participants who achieved EASI-50 (≥50% Improvement from baseline) at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing EASI score at Week 16 were counted as non-responders. | FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed. | Posted | Number | Percentage of participants | Week 16 |
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| Secondary | Percentage of Participants Who Achieved Eczema Area and Severity Index-50 (EASI-50) (Greater Than or Equal to [≥] 50% Improvement From Baseline) Based on All Observed Values Regardless of Rescue Treatment at Week 16 | The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percentage of participants who achieved EASI-50 (≥50% Improvement from baseline) at Week 16 were based on all observed values regardless of rescue treatment were reported. | FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed. | Posted | Number | Percentage of participants | Week 16 |
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| Secondary | Percentage of Participants Who Achieved Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percentage of participants who achieved EASI-75 (≥75% Improvement from baseline) at Week 16 based on observed values set to missing after rescue treatment were reported. Values after first rescue treatment were set to missing and participants with missing EASI score at Week 16 were counted as non-responders. | FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed. | Posted | Number | Percentage of participants | Week 16 |
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| Secondary | Percentage of Participants Who Achieved Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) Based on All Observed Values Regardless of Rescue Treatment at Week 16 | The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percentage of participants who achieved EASI-75 (≥75% Improvement from baseline) at Week 16 based on all observed values regardless of rescue treatment were reported. | FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed. | Posted | Number | Percentage of participants | Week 16 |
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| Secondary | Percentage of Participants Who Achieved Eczema Area and Severity Index-90 (EASI-90) (≥90% Improvement From Baseline) Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percentage of participants who achieved EASI-90 (≥90% Improvement from baseline) at Week 16 based on observed values set to missing after rescue treatment were reported. Values after first rescue treatment were set to missing and participants with missing EASI score at Week 16 were counted as non-responders. | FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed. | Posted | Number | Percentage of participants | Week 16 |
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| Secondary | Percentage of Participants Who Achieved Eczema Area and Severity Index-90 (EASI-90) (≥90% Improvement From Baseline) Based on All Observed Values Regardless of Rescue Treatment at Week 16 | The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Percentage of participants who achieved EASI-90 (≥90% Improvement from baseline) at Week 16 based on all observed values regardless of rescue treatment were reported. | FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed. | Posted | Number | Percentage of participants | Week 16 |
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| Secondary | Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | The EASI score was used to measure the severity and extent of AD and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Absolute change from baseline in EASI score at Week 16 based on observed values set to missing after rescue treatment was reported. | FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed. | Posted | Mean | Standard Deviation | Score on a scale | Week 16 |
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| Secondary | Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Score Based on All Observed Values Regardless of Rescue Treatment at Week 16 | The EASI score was used to measure the severity and extent of AD and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Absolute change from baseline in EASI score at Week 16 based on all observed values regardless of rescue treatment was reported. | FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed. | Posted | Mean | Standard Deviation | Score on a scale | Week 16 |
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| Secondary | Percentage of Participants With Both Investigator Global Assessment (IGA) Score 0 or 1 (on 0 to 5 IGA Scale) and a Reduction From Baseline of ≥2 Points Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | IGA was an assessment scale used to determine severity of AD and clinical response to treatment on a 5 point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). Participants with both IGA score of "0" or "1" and a reduction from baseline of ≥2 points at Week 16 based on observed values set to missing after rescue treatment were reported. Values after first rescue treatment were set to missing and participants with missing IGA score at Week 16 were counted as non-responders. | FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed. | Posted | Number | Percentage of participants | Week 16 |
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| Secondary | Percentage of Participants With Both IGA Score 0 or 1 (on the 0 to 5 IGA Scale) and a Reduction From Baseline of ≥2 Points Based on All Observed Values Regardless of Rescue Treatment at Week 16 | IGA was an assessment scale used to determine severity of AD and clinical response to treatment on a 5 point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). Participants with both IGA score of "0" or "1" and a reduction from baseline of ≥2 points at Week 16 based on all observed values regardless of rescue treatment were reported. | FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed. | Posted | Number | Percentage of participants | Week 16 |
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| Secondary | Absolute Change From Baseline in Weekly Average of Daily Peak Pruritus Numerical Rating Scale (NRS) Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Absolute change from baseline in weekly average of daily Peak Pruritus NRS score at Week 16 based on observed values set to missing after rescue treatment was reported. | FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed. | Posted | Mean | Standard Deviation | Score on a scale | Week 16 |
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| Secondary | Absolute Change From Baseline in Weekly Average of Daily Peak Pruritus NRS Score Based on All Observed Values Regardless of Rescue Treatment at Week 16 | Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Absolute Change From Baseline in Weekly Average of Daily Peak Pruritus NRS Score Based on All Observed Values Regardless of Rescue Treatment at Week 16 | FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed. | Posted | Mean | Standard Deviation | Score on a scale | Week 16 |
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| Secondary | Percent Change From Baseline in Weekly Average of Daily Peak Pruritus NRS Score Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Percent change from baseline in weekly average of daily peak pruritus NRS score at Week 16 based on observed values set to missing after rescue treatment was reported. Values after first rescue treatment were set to missing and participants with missing NRS score at Week 16 were counted as non-responders. | FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed. | Posted | Mean | Standard Deviation | Percentage of change | Week 16 |
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| Secondary | Percent Change From Baseline in Weekly Average of Daily Peak Pruritus NRS Score Based on All Observed Values Regardless of Rescue Treatment at Week 16 | Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Percent change from baseline in weekly average of daily peak pruritus NRS score at Week 16 based on all observed values regardless of rescue treatment was reported. | FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed. | Posted | Mean | Standard Deviation | Percentage of change | Week 16 |
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| Secondary | Percentage of Participants With Improvement (Reduction From Baseline) in Weekly Average of Peak Daily Pruritus NRS Score ≥4 Based on Observed Values Set to Missing After Rescue Treatment at Week 16 | Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Percentage of participants with improvement of weekly average of daily peak pruritus NRS score ≥4 from baseline to Week 16 based on observed values set to missing after rescue treatment were reported. Values after first rescue treatment were set to missing and participants with missing NRS score at Week 16 were counted as non-responders. | FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed. | Posted | Number | Percentage of participants | Week 16 |
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| Secondary | Percentage of Participants With Improvement (Reduction From Baseline) in Weekly Average of Daily Peak Pruritus NRS Score ≥4 Based on All Observed Values Regardless of Rescue Treatment at Week 16 | Pruritus NRS was an assessment tool used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, using an electronic questionnaire (e-diary). Participants were asked the following question: how would you rate your itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Percentage of participants with improvement of weekly average of daily peak pruritus NRS score ≥4 from baseline to Week 16 based on all observed values regardless of rescue treatment were reported. | FAS included all randomized participants and was based on the treatment allocated (as randomized). Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. Due to premature discontinuation, all statistical analyses were descriptive, and no hypothesis testing was performed. | Posted | Number | Percentage of participants | Week 16 |
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| Secondary | Time to Onset of Effect on Pruritus (≥4-point Reduction of Weekly Average of Daily Peak Pruritus NRS From Baseline) | Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period. Participants were asked the following question: For maximum itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours?" | Time to event analysis performed for participants in FAS with baseline weekly peak NRS score ≥4 and at least one post-baseline weekly peak NRS score reduced ≥4 points from baseline. Time to event was calculated in weeks as the (date of first event - the date of first dose)/7. The event of NRS reduction ≥4 was based on observed data regardless of rescue use. Here 'n' = number of evaluable participants analyzed at specified time frame. | Posted | Mean | Standard Deviation | Weeks | Week 16 |
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| Secondary | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 16 | The SCORAD index is a clinical tool for assessing the severity of atopic dermatitis (AD). Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease). | FAS; All observed values, regardless of rescue treatment use; Here 'n' = number of evaluable participants at the specific timepoint | Posted | Mean | Standard Deviation | Percentage of change | Week 16 |
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| Secondary | Absolute Change From Baseline in Percent Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement at Week 16 | BSA affected by AD will be assessed for each section of the body using the rule of nines (the possible highest score for each region is: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]) and will be reported as a percentage of all major body sections combined. The proportion assigned to different body regions is different in younger children as compared to older children (head and neck area is assigned a higher proportion in younger children as compared to older children). | FAS; All observed values regardless of rescue treatment use; Here 'n' = number of evaluable participants at the specific timepoint | Posted | Mean | Standard Deviation | Percentage of change | Week 16 |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) up to Week 16 | Adverse Event (AE): any untoward medical occurrence in a participant administered a study drug which may/may not have a causal relationship with study drug. Serious AE (SAE): any untoward medical occurrence that resulted in any of following outcomes: death, life-threatening, required initial/prolonged in-participant hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect/considered as medically important event. TEAE: AEs starting/worsening after first intake of study drug. TEAEs included: serious TEAEs and Non-serious TEAEs. AESI included: Anaphylactic or acute allergic reactions; Severe injection site reactions; Mycosis fungoides/other forms of cutaneous T-cell lymphoma; severe infections; any clinical endoparasitosis; Conjunctivitis, keratitis, or blepharitis; significant Alanine aminotransferase (ALT) elevation. Number of participants with TEAEs, Serious TEAES and AESIs from baseline up to Week 16 were reported. | The safety analysis set (SAF) included all randomized participants who received any study drug and was based on the treatment received (as treated). | Posted | Count of Participants | Participants | Up to week 16 |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs) up to Week 36 | AE: any untoward medical occurrence in a participant administered a study drug which may/may not have a causal relationship with study drug. SAE: any untoward medical occurrence that resulted in any of following outcomes: death, life-threatening, required initial/prolonged in-participant hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect/considered as medically important event. TEAE: AEs starting/worsening after first intake of study drug. TEAEs included both Serious TEAEs and Non-serious TEAEs. AESI included: Anaphylactic or acute allergic reactions; Severe injection site reactions; Mycosis fungoides/other forms of cutaneous T-cell lymphoma; severe infections; any clinical endoparasitosis; Conjunctivitis, keratitis, or blepharitis; significant Alanine aminotransferase (ALT) elevation. Number of participants with TEAEs, Serious TEAES and AESIs from baseline up to Week 36 were reported. | SAF included all randomized participants who received any study drug and was based on the treatment received (as treated). | Posted | Count of Participants | Participants | Up to week 36 |
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| Secondary | Serum Concentration of Functional REGN3500 | Serum Concentration of Functional REGN3500 was reported. | The Pharmacokinetic (PK) analysis set included all randomized participants who received any study drug and who had at least 1 non-missing study drug concentration result following the first dose of study drug. Here, "Number Analyzed" signifies those participants who were evaluable at given time points. | Posted | Mean | Standard Deviation | Milligrams per Liter (mg/L) | Baseline (Week 0), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32 and 36 |
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| Secondary | Number of Participants With Positive Treatment-Emergent Anti-REGN3500 Antibodies (ADA) | Treatment-Emergent (TE) ADA was defined as any positive post baseline assay response when baseline results were negative or missing. Treatment-Emergent ADA responses were further classified as: - persistent (treatment-emergent positive ADA response detected in at least 2 consecutive post baseline samples separated by at least a 16-week post baseline period [based on nominal sampling time], with no ADA-negative samples in-between, regardless of any missing samples or a positive response at the last ADA sampling time point),- indeterminate (a positive assay response at the last collection time point only, regardless of any missing samples), - transient (not persistent/indeterminate, regardless of any missing samples). Number of participants with positive treatment-emergent anti-REGN3500 antibodies (ADA) were reported. Here, "Number of Participants Analyzed" signifies those participants who were evaluable for this endpoint. | The Anti-drug Antibodies (ADA) analysis set included all treated participants who received any amount of study drug (active or placebo [safety analysis set]) and had at least one non-missing anti-REGN3500 result following the first dose of study drug or placebo. | Posted | Count of Participants | Participants | Up to week 36 |
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All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Q2W | Participants received 3 subcutaneous (SC) injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14. | 0 | 25 | 0 | 25 | 7 | 25 |
| EG001 | R3500 30 mg Q8W | Participants received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14. | 0 | 26 | 0 | 26 | 11 | 26 |
| EG002 | R3500 100 mg Q4W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. | 0 | 26 | 0 | 26 | 9 | 26 |
| EG003 | R3500 300 mg Q4W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. | 0 | 24 | 1 | 24 | 8 | 24 |
| EG004 | R3500 300 mg Q2W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14. | 1 | 26 | 2 | 26 | 10 | 26 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis norovirus | Infections and infestations | MedDRA (23) | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (23) | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (23) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (23) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (23) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (23) | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA (23) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (23) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (23) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (23) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (23) | Systematic Assessment |
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The decision was made by the sponsor to terminate the study on 12 Feb 2020 due to lack of efficacy. Study enrollment was not complete at that time, therefore planned sample sizes were not met. Participants discontinued study drug and transitioned into the post-treatment follow-up period. As a result of the decision to terminate the study, all statistical analyses were descriptive and no hypothesis testing was performed.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Administrator | Regeneron Pharmaceuticals, Inc. | 844-734-6643 | clinicaltrials@regeneron.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 18, 2020 | Dec 15, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C000720033 | itepekimab |
Not provided
Not provided
Not provided
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| OG002 | REGN3500 100 mg Q4W | Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. |
| OG003 | REGN3500 300 mg Q4W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. |
| OG004 | REGN3500 300 mg Q2W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14. |
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Participants received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
| OG002 | REGN3500 100 mg Q4W | Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. |
| OG003 | REGN3500 300 mg Q4W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. |
| OG004 | REGN3500 300 mg Q2W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14. |
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| OG002 | REGN3500 100 mg Q4W | Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. |
| OG003 | REGN3500 300 mg Q4W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. |
| OG004 | REGN3500 300 mg Q2W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14. |
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Participants received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
| OG002 | REGN3500 100 mg Q4W | Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. |
| OG003 | REGN3500 300 mg Q4W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. |
| OG004 | REGN3500 300 mg Q2W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14. |
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| OG002 | REGN3500 100 mg Q4W | Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. |
| OG003 | REGN3500 300 mg Q4W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. |
| OG004 | REGN3500 300 mg Q2W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14. |
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Participants received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
| OG002 | REGN3500 100 mg Q4W | Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. |
| OG003 | REGN3500 300 mg Q4W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. |
| OG004 | REGN3500 300 mg Q2W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14. |
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| OG002 | REGN3500 100 mg Q4W | Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. |
| OG003 | REGN3500 300 mg Q4W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. |
| OG004 | REGN3500 300 mg Q2W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14. |
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| OG002 | REGN3500 100 mg Q4W | Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. |
| OG003 | REGN3500 300 mg Q4W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. |
| OG004 | REGN3500 300 mg Q2W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14. |
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| OG002 | REGN3500 100 mg Q4W | Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. |
| OG003 | REGN3500 300 mg Q4W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. |
| OG004 | REGN3500 300 mg Q2W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14. |
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Participants received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14.
| OG002 | REGN3500 100 mg Q4W | Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. |
| OG003 | REGN3500 300 mg Q4W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. |
| OG004 | REGN3500 300 mg Q2W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14. |
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| OG002 | REGN3500 100 mg Q4W | Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. |
| OG003 | REGN3500 300 mg Q4W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. |
| OG004 | REGN3500 300 mg Q2W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14. |
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| OG002 | REGN3500 100 mg Q4W | Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. |
| OG003 | REGN3500 300 mg Q4W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. |
| OG004 | REGN3500 300 mg Q2W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14. |
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| OG002 | REGN3500 100 mg Q4W | Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. |
| OG003 | REGN3500 300 mg Q4W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. |
| OG004 | REGN3500 300 mg Q2W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14. |
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Participants received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14. |
| OG002 | REGN3500 100 mg Q4W | Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. |
| OG003 | REGN3500 300 mg Q4W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. |
| OG004 | REGN3500 300 mg Q2W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14. |
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| OG002 | REGN3500 100 mg Q4W | Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. |
| OG003 | REGN3500 300 mg Q4W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. |
| OG004 | REGN3500 300 mg Q2W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14. |
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| REGN3500 30 mg Q8W |
Participants received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14. |
| OG002 | REGN3500 100 mg Q4W | Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. |
| OG003 | REGN3500 300 mg Q4W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. |
| OG004 | REGN3500 300 mg Q2W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14. |
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| OG002 | REGN3500 100 mg Q4W | Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. |
| OG003 | REGN3500 300 mg Q4W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. |
| OG004 | REGN3500 300 mg Q2W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14. |
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| OG002 | REGN3500 100 mg Q4W | Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. |
| OG003 | REGN3500 300 mg Q4W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. |
| OG004 | REGN3500 300 mg Q2W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14. |
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| OG003 | REGN3500 300 mg Q4W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. |
| OG004 | REGN3500 300 mg Q2W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14. |
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| REGN3500 100 mg Q4W |
Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. |
| OG003 | REGN3500 300 mg Q4W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. |
| OG004 | REGN3500 300 mg Q2W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14. |
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| REGN3500 30 mg Q8W |
Participants received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14. |
| OG002 | REGN3500 100 mg Q4W | Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. |
| OG003 | REGN3500 300 mg Q4W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. |
| OG004 | REGN3500 300 mg Q2W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14. |
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Participants received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14. |
| OG002 | REGN3500 100 mg Q4W | Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. |
| OG003 | REGN3500 300 mg Q4W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. |
| OG004 | REGN3500 300 mg Q2W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14. |
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| OG003 | REGN3500 300 mg Q4W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. |
| OG004 | REGN3500 300 mg Q2W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14. |
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| REGN3500 30 mg Q8W |
Participants received 1 SC injection of REGN3500 (30 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 4, 6, 10, 12, and 14. |
| OG002 | REGN3500 100 mg Q4W | Participants received 1 SC injection of REGN3500 (100 mg total dose) along with 2 SC injections of placebo matched to REGN3500 on Day 1 and Week 8 and 1 SC injection of REGN3500 (100 mg total dose) in combination with 1 SC injection of placebo matched to REGN3500 at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. |
| OG003 | REGN3500 300 mg Q4W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 4 and 12 and 2 SC injections of placebo matched to REGN3500 at Weeks 2, 6, 10, and 14. |
| OG004 | REGN3500 300 mg Q2W | Participants received 2 SC injections of REGN3500 (300 mg total dose) along with 1 SC injection of placebo matched to REGN3500 on Day 1 and Week 8 and 2 SC injections of REGN3500 (300 mg total dose) at Weeks 2, 4, 6, 10, 12 and 14. |
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