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| ID | Type | Description | Link |
|---|---|---|---|
| H0P-MC-BP01 | Other Identifier | Eli Lilly and Company |
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This study is being done to test the safety and efficacy of the study drug LY3016859 for the treatment of chronic low back pain. This trial is part of the chronic pain master protocol H0P-MC-CPMP (NCT05986292) which is a protocol to accelerate the development of new treatments for chronic pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 750 Mg-500 mg LY3016859 | Experimental | Participants received LY3016859 every 2 weeks with 750 milligram (mg) as starting dose followed by 500 mg intravenous (IV) infusion for a total of 4 doses |
|
| Placebo | Placebo Comparator | Participants received placebo every 2 weeks by IV infusion for a total of 4 doses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3016859 | Drug | Administered IV |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline for Average Pain Intensity as Measured by the NRS | The NRS was used during the preliminary data entry period and daily throughout the study to describe pain severity. Participants were asked to describe their average pain over the past 24 hours, on a scale of 0 to 10: 0 = no pain, and 10 = pain as bad as you can imagine. Posterior mean change from baseline, 95% credible interval (CrI) was derived using Bayesian mixed model repeated measures. The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals | Baseline, up to Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline on the Roland Morris Disability Questionnaire (RMDQ) | The RMDQ is a simple, sensitive, and reliable method to measure disability in patients with back pain that consists of 24 statements relating to the person's perceptions of back pain and associated disability based on physical ability/activity, sleep/rest, psychosocial, household management, eating, and pain frequency. Participants are asked if they feel the statement is descriptive of their own circumstance on that day. The total score is obtained by counting the number of ''Yes'' responses, ranging from: 0 = no disability to 24 = maximal disability. Posterior mean change from baseline, 95% CrI was derived using Bayesian mixed model repeated measures. The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM -5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Simon Williamson Clinic | Birmingham | Alabama | 35211 | United States | ||
| Synexus - US |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40266472 | Derived | James DE, Bailey J, van der Walt JS, Winkler J, Schoemaker R. Population Pharmacokinetics and Pharmacodynamics of Fepixnebart (LY3016859) and Epiregulin in Patients with Chronic Pain. Clin Pharmacokinet. 2025 May;64(5):757-767. doi: 10.1007/s40262-025-01506-3. Epub 2025 Apr 23. |
| Label | URL |
|---|---|
| Chronic Pain Master Protocol (CPMP): A Study of LY3016859 in Participants With Chronic Low Back Pain | View source |
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Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | 750 Mg-500 Milligram (mg) LY3016859 | Participants received LY3016859 every 2 weeks with 750 mg as starting dose followed by 500 mg IV infusion for a total of 4 doses. |
| FG001 | Placebo |
| 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 | May 11, 2020 | Apr 8, 2022 |
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| Drug |
Administered IV |
|
| Baseline, up to Week 8 |
| Change From Baseline for Overall Improvement as Measured by Patient's Global Impression of Change (PGI) | Patients Global Impression of Change captured the participant's perspective of treatment apart from sub-aspects of the general improvement. This is a numeric scale from 1 to 7: 1 = very much better, and 7 = very much worse. Posterior mean change from baseline, 95% CrI was derived using Bayesian mixed model repeated measures. The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals. | Baseline, up to Week 8 |
| Change From Baseline for Worst Pain Intensity as Measured by NRS | The NRS was used during the preliminary data entry period and daily throughout the study to describe pain severity. Participants were asked to describe their worst pain over the past 24 hours, on a scale of 0 to 10: 0 = no pain, and 10 = pain as bad as you can imagine. Posterior mean change from baseline, 95% CrI was derived using Bayesian mixed model repeated measures. The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals. | Baseline, up to Week 8 |
| Change From Baseline on the Visual Analog Scale (VAS) for Pain | VAS was a graphic, single-item scale where participants were asked to describe their pain intensity over the past week, on a scale of 0 to 100: 0 = no pain, and 100 = worst imaginable pain. Participants completed the VAS by placing a line perpendicular to the VAS line at a point that described their pain intensity. Posterior mean change from baseline, 95% CrI was derived using Bayesian mixed model repeated measures. The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals. | Baseline, up to Week 8 |
| Change From Baseline Assessment to Endpoint on the Sleep Scale From the Medical Outcomes Study (MOS Sleep Scale) | The MOS Sleep Scale consists of 12 questions addressing the past week. Participants reported how often each sleep symptom or problem was present on a 5-point categorical scale ranging from 'all of the time' to 'none of the time.' It includes 12 questions with the first question assessing how long it takes the subject to fall asleep. The second question asks how many hours each night the subject slept. The remaining 10 questions have a range of 6 responses from 1="all of the time" to 6="none of the time". MOS Sleep scale scores range from 0 (min) to 100 (max). The original survey items are converted to a 0 to 100 range (by Converting 1 to 0, 2 to 25, 3 to 50, 4 to 75, and 5 to 100). Higher scores represent worse outcomes. Posterior mean change from baseline, 95% CrI was derived using Bayesian longitudinal model. The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals. | Baseline, up to Week 8 |
| Total Amount of Rescue Medication Use as Measured by Average Dosage Per Week | Total Amount of Rescue Medication Use as Measured by Average Dosage per Week. Posterior mean change from baseline, 95% CrI was derived using Bayesian mixed model repeated measures. The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence interval. | Baseline up to Week 8 |
| Change From Baseline on the EuroQol-5D 5 Level Questionnaire (EQ-5D-5L) (United States) | The EQ-5D-5L assessed quality of life based on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant was asked to 'check the ONE box that best describes your health TODAY,' choosing from 5 options (no problems, slight problems, moderate problems, severe problems, extreme problems) provided under each dimension. The scores in the 5 dimensions were summarized into a health state index score. The health state index value is a single value on a scale from less than 0 to 1 (negative values are valued as worse than dead) with higher scores indicating better health: 0 = a health state equivalent to death, and 1 = perfect health. Posterior mean change from baseline, 95% CrI was derived using Bayesian mixed model repeated measures. The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals. | Baseline, up to Week 8 |
| Chandler |
| Arizona |
| 85224 |
| United States |
| Synexus- Chandler | Chandler | Arizona | 85224 | United States |
| Irvine Clinical Research Center | Irvine | California | 92614 | United States |
| Artemis Institute for Clinical Research | Riverside | California | 92503 | United States |
| Artemis Institute for Clinical Research | San Diego | California | 92103 | United States |
| VIN-Julie Schwartzbard | Aventura | Florida | 33180 | United States |
| Suncoast Research Group | Miami | Florida | 33135 | United States |
| Renstar Medical Research | Ocala | Florida | 34470 | United States |
| Synexus - US | Orlando | Florida | 32806 | United States |
| Synexus - US | Pinellas Park | Florida | 33781 | United States |
| Martin E. Hale M.D., P.A. | Plantation | Florida | 33317 | United States |
| Synexus - US | The Villages | Florida | 32162 | United States |
| Synexus Clinical Research | Chicago | Illinois | 60602 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Cotton O'Neil Infusion Center | Topeka | Kansas | 66606 | United States |
| ActivMed Practices and Research | Methuen | Massachusetts | 01844 | United States |
| MedVadis Research Corporation | Waltham | Massachusetts | 02451 | United States |
| Great Lakes Research Group, Inc. | Bay City | Michigan | 48706 | United States |
| StudyMetrix Research | City of Saint Peters | Missouri | 63303 | United States |
| Synexus - US | Omaha | Nebraska | 68144 | United States |
| PharmQuest | Greensboro | North Carolina | 27408 | United States |
| Synexus - Cincinnati | Cincinnati | Ohio | 45236 | United States |
| Rapid Medical Research | Cleveland | Ohio | 44122 | United States |
| Aventiv Research Inc | Columbus | Ohio | 43213 | United States |
| Altoona Center For Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| Clinical Research Center of Reading,LLC | Wyomissing | Pennsylvania | 19610 | United States |
| Coastal Carolina Research Center | North Charleston | South Carolina | 29405 | United States |
| Synexus - US | Dallas | Texas | 75234 | United States |
| Synexus - San Antonio | San Antonio | Texas | 78229 | United States |
| Synexus - US | Murray | Utah | 84123 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98007-4209 | United States |
| Rainier Clinical Research Center | Renton | Washington | 98057 | United States |
| Latin Clinical Trial Center | San Juan | PR | 00909 | Puerto Rico |
Participants received placebo every 2 weeks by IV infusion for a total of 4 doses.
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All enrolled or randomized participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | 750 Mg-500 mg LY3016859 | Participants received LY3016859 every 2 weeks with 750 mg as starting dose followed by 500 mg IV infusion for a total of 4 doses. |
| BG001 | Placebo | Participants received placebo every 2 weeks by IV infusion for a total of 4 doses. |
| BG002 | 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, Categorical | Count of Participants | Participants | No |
| |||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Average Pain Intensity as Measured by the Numeric Rating Scale (NRS) | The NRS was used during the preliminary data entry period and daily throughout the study to describe pain severity. Participants were asked to describe their average pain over the past 24 hours, on a scale of 0 to 10: 0 = no pain, and 10 = pain as bad as you can imagine. | 1 participant had baseline data missing. | Mean | Standard Deviation | score on a scale |
|
| 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 for Average Pain Intensity as Measured by the NRS | The NRS was used during the preliminary data entry period and daily throughout the study to describe pain severity. Participants were asked to describe their average pain over the past 24 hours, on a scale of 0 to 10: 0 = no pain, and 10 = pain as bad as you can imagine. Posterior mean change from baseline, 95% credible interval (CrI) was derived using Bayesian mixed model repeated measures. The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals | All enrolled or randomized participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 8. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, up to Week 8 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline on the Roland Morris Disability Questionnaire (RMDQ) | The RMDQ is a simple, sensitive, and reliable method to measure disability in patients with back pain that consists of 24 statements relating to the person's perceptions of back pain and associated disability based on physical ability/activity, sleep/rest, psychosocial, household management, eating, and pain frequency. Participants are asked if they feel the statement is descriptive of their own circumstance on that day. The total score is obtained by counting the number of ''Yes'' responses, ranging from: 0 = no disability to 24 = maximal disability. Posterior mean change from baseline, 95% CrI was derived using Bayesian mixed model repeated measures. The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals. | All enrolled or randomized participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 8. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, up to Week 8 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline for Overall Improvement as Measured by Patient's Global Impression of Change (PGI) | Patients Global Impression of Change captured the participant's perspective of treatment apart from sub-aspects of the general improvement. This is a numeric scale from 1 to 7: 1 = very much better, and 7 = very much worse. Posterior mean change from baseline, 95% CrI was derived using Bayesian mixed model repeated measures. The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals. | All enrolled or randomized participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 8. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, up to Week 8 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline for Worst Pain Intensity as Measured by NRS | The NRS was used during the preliminary data entry period and daily throughout the study to describe pain severity. Participants were asked to describe their worst pain over the past 24 hours, on a scale of 0 to 10: 0 = no pain, and 10 = pain as bad as you can imagine. Posterior mean change from baseline, 95% CrI was derived using Bayesian mixed model repeated measures. The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals. | All enrolled or randomized participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 8. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, up to Week 8 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline on the Visual Analog Scale (VAS) for Pain | VAS was a graphic, single-item scale where participants were asked to describe their pain intensity over the past week, on a scale of 0 to 100: 0 = no pain, and 100 = worst imaginable pain. Participants completed the VAS by placing a line perpendicular to the VAS line at a point that described their pain intensity. Posterior mean change from baseline, 95% CrI was derived using Bayesian mixed model repeated measures. The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals. | All enrolled or randomized participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 8. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, up to Week 8 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline Assessment to Endpoint on the Sleep Scale From the Medical Outcomes Study (MOS Sleep Scale) | The MOS Sleep Scale consists of 12 questions addressing the past week. Participants reported how often each sleep symptom or problem was present on a 5-point categorical scale ranging from 'all of the time' to 'none of the time.' It includes 12 questions with the first question assessing how long it takes the subject to fall asleep. The second question asks how many hours each night the subject slept. The remaining 10 questions have a range of 6 responses from 1="all of the time" to 6="none of the time". MOS Sleep scale scores range from 0 (min) to 100 (max). The original survey items are converted to a 0 to 100 range (by Converting 1 to 0, 2 to 25, 3 to 50, 4 to 75, and 5 to 100). Higher scores represent worse outcomes. Posterior mean change from baseline, 95% CrI was derived using Bayesian longitudinal model. The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals. | All enrolled or randomized participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 8. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, up to Week 8 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Total Amount of Rescue Medication Use as Measured by Average Dosage Per Week | Total Amount of Rescue Medication Use as Measured by Average Dosage per Week. Posterior mean change from baseline, 95% CrI was derived using Bayesian mixed model repeated measures. The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence interval. | All enrolled or randomized participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 8. | Posted | Mean | 95% Confidence Interval | mg per week | Baseline up to Week 8 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline on the EuroQol-5D 5 Level Questionnaire (EQ-5D-5L) (United States) | The EQ-5D-5L assessed quality of life based on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant was asked to 'check the ONE box that best describes your health TODAY,' choosing from 5 options (no problems, slight problems, moderate problems, severe problems, extreme problems) provided under each dimension. The scores in the 5 dimensions were summarized into a health state index score. The health state index value is a single value on a scale from less than 0 to 1 (negative values are valued as worse than dead) with higher scores indicating better health: 0 = a health state equivalent to death, and 1 = perfect health. Posterior mean change from baseline, 95% CrI was derived using Bayesian mixed model repeated measures. The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals. | All enrolled or randomized participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 8. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, up to Week 8 |
|
Baseline through Week 26
All enrolled or randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
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 | 750 Mg-500 mg LY3016859 | Participants received LY3016859 every 2 weeks with 750 mg as starting dose followed by 500 mg IV infusion for a total of 4 doses. | 0 | 100 | 8 | 100 | 38 | 100 |
| EG001 | Placebo | Participants received placebo every 2 weeks by IV infusion for a total of 4 doses | 0 | 49 | 0 | 49 | 13 | 49 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Covid-19 pneumonia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Infusion site pain | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Xerosis | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Vulvovaginal erythema | Reproductive system and breast disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 6, 2021 | Apr 8, 2022 | SAP_001.pdf |
| Between 18 and 65 years |
|
| >=65 years |
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| Participants |
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| Participants |
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| Counts |
|---|
| Participants |
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Participants received placebo every 2 weeks by IV infusion for a total of 4 doses. |
|
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Participants received placebo every 2 weeks by IV infusion for a total of 4 doses.
|
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