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This was a Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab administered subcutaneously as an add-on therapy for the treatment of adolescent and adult participants 12 - 75 years who received the diagnosis of refractory chronic spontaneous uriticaria and who remained symptomatic despite standard-dosed non-sedating H1 antihistamine treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omalizumab 300 mg | Experimental | Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period. |
|
| Omalizumab 150 mg | Experimental | Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period. |
|
| Placebo | Placebo Comparator | Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omalizumab | Biological | Omalizumab was supplied as a lyophilized, sterile powder in a single-use vial. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Weekly Itch Severity Score at Week 12 | The weekly itch severity score is a component of the Urticaria Activity Score 7 (UAS7) composite score. The UAS7 is a composite score of the number of wheals (hives) and the severity of the itch. The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching. A negative change score from baseline indicates improvement. | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Urticaria Activity Score Over 7 Days (UAS7) at Week 12 | The UAS7 is a composite score of the number of wheals (hives) and the severity of the itch. The UAS7 is determined by the sum of the daily urticaria activity scores over 7 days and ranges from 0 to 42. The daily urticaria activity score is the average of the morning and evening urticaria activity scores and ranges from 0 to 6. The urticaria activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticaria activity scores over the 7 days prior to the first treatment. A higher urticaria activity score indicates more severe symptoms. A negative change score from baseline indicates improvement. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Toyoake | Aichi-ken | 470-1192 | Japan | ||
| Novartis Investigative Site |
Participants were randomly assigned to the 3 treatment groups in a 1:1:1 ratio.
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| ID | Title | Description |
|---|---|---|
| FG000 | Omalizumab 300 mg | Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period. |
| FG001 | Omalizumab 150 mg | Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Other | Placebo was supplied as a lyophilized, sterile powder in a single-use vial without study drug. |
|
| Baseline to Week 12 |
| Change From Baseline in the Weekly Number of Hives Score at Week 12 | The weekly hives score is the sum of the daily hives scores over 7 days and ranges from 0 to 21. The number of hives is measured twice daily (morning and evening) on a scale of 0 (none) to 3 (> 12 hives per 12 hours). The daily hives score is the average of the morning and evening scores. The Baseline score is the sum of the daily hives scores over the 7 days prior to the first treatment. A higher score indicates more hives. A negative change score indicates improvement. | Baseline to Week 12 |
| Percentage of Participants With a UAS7 Score ≤ 6 at Week 12 | The UAS7 is a composite score of the number of wheals (hives) and the severity of the itch. The UAS7 is determined by the sum of the daily urticaria activity scores over 7 days and ranges from 0 to 42. The daily urticaria activity score is the average of the morning and evening urticaria activity scores and ranges from 0 to 6. The urticaria activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticaria activity scores over the 7 days prior to the first treatment. A higher urticaria activity score indicates more severe symptoms. | Week 12 |
| Change From Baseline in the Weekly Size of the Largest Hive Score at Week 12 | The weekly size of the largest hive score is the sum of the daily size of the largest hive scores over 7 days and ranges from 0 to 21. The daily size of the largest hive score is assessed twice daily (morning and evening) on a scale of 0 (none) to 3 (> 2.5 cm). The daily size of the largest hive score is the average of the morning and evening scores. The Baseline weekly size of the largest hive score is calculated over the 7 days prior to the first treatment. A higher score indicates larger hives. A negative change score from baseline indicates a reduction in hive size. | Baseline to Week 12 |
| Percentage of Weekly Itch Severity Score Minimally Important Difference (MID) Responders at Week 12 | Weekly itch severity score MID response is defined as a reduction from baseline in weekly itch severity score of ≥ 5 points. | Week 12 |
| Percentage of Complete Responders (UAS7 = 0) at Week 12 | Complete responders are defined as participants who achieved UAS7 = 0. | Week 12 |
| Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 12 | The DLQI is a 10-item dermatology-specific health-related quality of life measure. Participants rated their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives on a scale of 0 (Not at all) to 3 (Very much). The overall DLQI is the sum of the responses to the 10 items and ranges from 0 to 30. A lower score indicates a better quality of life. A negative change score from baseline indicates improvement. | Baseline to Week 12 |
| Percentage of Participants With Production of Anti-omalizumab Antibody | Serum samples were collected for anti-omalizumab antibody testing. | Week 24 |
| Hiroshima |
| Hiroshima |
| 734-8551 |
| Japan |
| Novartis Investigative Site | Kobe | Hyōgo | 650-0017 | Japan |
| Novartis Investigative Site | Nishinomiya | Hyōgo | 663-8186 | Japan |
| Novartis Investigative Site | Hitachi | Ibaraki | 317-0077 | Japan |
| Novartis Investigative Site | Takamatsu | Kagawa-ken | 760-0017 | Japan |
| Novartis Investigative Site | Kawasaki | Kanagawa | 213-8507 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa | 221-0825 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa | 231-0868 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa | 236-0004 | Japan |
| Novartis Investigative Site | Yokosuka | Kanagawa | 238-8558 | Japan |
| Novartis Investigative Site | Kamimashi-gun | Kumamoto | 861-3101 | Japan |
| Novartis Investigative Site | Nagano | Nagano | 381-8551 | Japan |
| Novartis Investigative Site | Osaka | Osaka | 532-0003 | Japan |
| Novartis Investigative Site | Sakai | Osaka | 593-8324 | Japan |
| Novartis Investigative Site | Saitama | Saitama | 330-0854 | Japan |
| Novartis Investigative Site | Izumo | Shimane | 693-8501 | Japan |
| Novartis Investigative Site | Kodaira | Tokyo | 187-8510 | Japan |
| Novartis Investigative Site | Machida | Tokyo | 194-0013 | Japan |
| Novartis Investigative Site | Meguro-ku | Tokyo | 153-8515 | Japan |
| Novartis Investigative Site | Minato-ku | Tokyo | 107-6206 | Japan |
| Novartis Investigative Site | Ōta-ku | Tokyo | 143-0023 | Japan |
| Novartis Investigative Site | Shinagawa-ku | Tokyo | 141-8625 | Japan |
| Novartis Investigative Site | Shinjuku-ku | Tokyo | 161-8521 | Japan |
| Novartis Investigative Site | Kofu | Yamanashi | 400-8506 | Japan |
| Novartis Investigative Site | Wŏnju | Gangwon-do | 220-701 | South Korea |
| Novartis Investigative Site | Hwaseong-si | Gyeonggi-do | 445-170 | South Korea |
| Novartis Investigative Site | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
| Novartis Investigative Site | Suwon | Gyeonggi-do | 443-380 | South Korea |
| Novartis Investigative Site | Seoul | Korea | 05505 | South Korea |
| Novartis Investigative Site | Seoul | Korea | 06591 | South Korea |
| Novartis Investigative Site | Seoul | Korea | 152-703 | South Korea |
| Novartis Investigative Site | Seoul | Seoul | 156-755 | South Korea |
| Novartis Investigative Site | Busan | 602-715 | South Korea |
| Novartis Investigative Site | Daegu | 705-703 | South Korea |
| Novartis Investigative Site | Gwangju | 501-757 | South Korea |
| Novartis Investigative Site | Incheon | 405-760 | South Korea |
| Novartis Investigative Site | Seoul | 120-752 | South Korea |
| Novartis Investigative Site | Seoul | 130-872 | South Korea |
| FG002 | Placebo | Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period. |
| Full Analysis Set |
|
| Safety Set |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Omalizumab 300 mg | Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period. |
| BG001 | Omalizumab 150 mg | Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period. |
| BG002 | Placebo | Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period. |
| BG003 | 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 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in the Weekly Itch Severity Score at Week 12 | The weekly itch severity score is a component of the Urticaria Activity Score 7 (UAS7) composite score. The UAS7 is a composite score of the number of wheals (hives) and the severity of the itch. The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching. A negative change score from baseline indicates improvement. | The Full Analysis Set (FAS) was analyzed. The FAS included all participants who were diagnosed with chronic spontaneous urticaria(CSU) and received the assigned study treatment. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline to Week 12 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Urticaria Activity Score Over 7 Days (UAS7) at Week 12 | The UAS7 is a composite score of the number of wheals (hives) and the severity of the itch. The UAS7 is determined by the sum of the daily urticaria activity scores over 7 days and ranges from 0 to 42. The daily urticaria activity score is the average of the morning and evening urticaria activity scores and ranges from 0 to 6. The urticaria activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticaria activity scores over the 7 days prior to the first treatment. A higher urticaria activity score indicates more severe symptoms. A negative change score from baseline indicates improvement. | The Full Analysis Set (FAS) was analyzed. The FAS included all participants who were diagnosed with chronic spontaneous urticaria (CSU) and received the assigned study treatment. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline to Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Weekly Number of Hives Score at Week 12 | The weekly hives score is the sum of the daily hives scores over 7 days and ranges from 0 to 21. The number of hives is measured twice daily (morning and evening) on a scale of 0 (none) to 3 (> 12 hives per 12 hours). The daily hives score is the average of the morning and evening scores. The Baseline score is the sum of the daily hives scores over the 7 days prior to the first treatment. A higher score indicates more hives. A negative change score indicates improvement. | The Full Analysis Set (FAS) was analyzed. The FAS included all participants who were diagnosed with chronic spontaneous urticaria (CSU) and received the assigned study treatment. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline to Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a UAS7 Score ≤ 6 at Week 12 | The UAS7 is a composite score of the number of wheals (hives) and the severity of the itch. The UAS7 is determined by the sum of the daily urticaria activity scores over 7 days and ranges from 0 to 42. The daily urticaria activity score is the average of the morning and evening urticaria activity scores and ranges from 0 to 6. The urticaria activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticaria activity scores over the 7 days prior to the first treatment. A higher urticaria activity score indicates more severe symptoms. | The Full Analysis Set (FAS) was analyzed. The FAS included all participants who were diagnosed with chronic spontaneous urticaria (CSU) and received the assigned study treatment. | Posted | Number | Percentage of participants | Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Weekly Size of the Largest Hive Score at Week 12 | The weekly size of the largest hive score is the sum of the daily size of the largest hive scores over 7 days and ranges from 0 to 21. The daily size of the largest hive score is assessed twice daily (morning and evening) on a scale of 0 (none) to 3 (> 2.5 cm). The daily size of the largest hive score is the average of the morning and evening scores. The Baseline weekly size of the largest hive score is calculated over the 7 days prior to the first treatment. A higher score indicates larger hives. A negative change score from baseline indicates a reduction in hive size. | The Full Analysis Set (FAS) was analyzed. The FAS included all participants who were diagnosed with chronic spontaneous urticaria (CSU) and received the assigned study treatment. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline to Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Weekly Itch Severity Score Minimally Important Difference (MID) Responders at Week 12 | Weekly itch severity score MID response is defined as a reduction from baseline in weekly itch severity score of ≥ 5 points. | The Full Analysis Set (FAS) was analyzed. The FAS included all participants who were diagnosed with chronic spontaneous urticaria (CSU) and received the assigned study treatment. | Posted | Number | Percentage of participants | Week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Complete Responders (UAS7 = 0) at Week 12 | Complete responders are defined as participants who achieved UAS7 = 0. | The Full Analysis Set (FAS) was analyzed. The FAS included all participants who were diagnosed with chronic spontaneous urticaria (CSU) and received the assigned study treatment. | Posted | Number | Percentage of participants | Week 12 |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 12 | The DLQI is a 10-item dermatology-specific health-related quality of life measure. Participants rated their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives on a scale of 0 (Not at all) to 3 (Very much). The overall DLQI is the sum of the responses to the 10 items and ranges from 0 to 30. A lower score indicates a better quality of life. A negative change score from baseline indicates improvement. | Only participants from the FAS, who were greater than age 16, were analyzed. The Full Analysis Set (FAS) was analyzed. The FAS included all participants who were diagnosed with chronic spontaneous urticaria (CSU) and received the assigned study treatment. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline to Week 12 |
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| Secondary | Percentage of Participants With Production of Anti-omalizumab Antibody | Serum samples were collected for anti-omalizumab antibody testing. | The safety analysis set, which included all participants who received their assigned study treatment, were considered for the analysis. Only participants, who had antibody results (conclusive or inconclusive), were analyzed. | Posted | Number | Percentage of participants | Week 24 |
|
|
over 24 weeks following randomization
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IGE025 300 mg | IGE025 300 mg | 3 | 73 | 32 | 73 | ||
| EG001 | IGE025 150 mg | IGE025 150 mg | 3 | 71 | 25 | 71 | ||
| EG002 | Placebo | Placebo | 0 | 74 | 29 | 74 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CHOLECYSTITIS CHRONIC | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| LIMB TRAUMATIC AMPUTATION | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| SPINAL CORD INJURY | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| CONJUNCTIVITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| CYSTITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| FOLLICULITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| OTITIS EXTERNA | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| PHARYNGITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| MIGRAINE | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| SOMNOLENCE | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| ACNE | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| CHRONIC SPONTANEOUS URTICARIA | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| DERMATITIS CONTACT | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| ECZEMA | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| MILIARIA | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| URTICARIA | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| HYPERTENSION | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis | 862-778-8300 |
| ID | Term |
|---|---|
| D000069444 | Omalizumab |
| ID | Term |
|---|---|
| D000888 | Antibodies, Anti-Idiotypic |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
| 0.006 |
| Mean Difference (Net) |
| -2.29 |
| Standard Error of the Mean |
| 0.828 |
| 2-Sided |
| 95 |
| -3.921 |
| -0.654 |
| No |
| Superiority or Other |
| OG002 | Placebo | Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period. |
|
|
|
|
| Placebo |
Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period. |
|
|
Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.
|
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| Participants |
|
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|
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