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| Name | Class |
|---|---|
| PPD Development, LP | INDUSTRY |
| ICON plc | INDUSTRY |
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The purpose of this study is to determine the ability of XmAb5871 to maintain Systemic Lupus Erythematosus (SLE) disease activity improvement achieved by a brief course of disease-suppressing steroid therapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XmAb5871 | Experimental | XmAb5871 administered by IV infusion for up to a total of 16 infusions |
|
| Placebo | Placebo Comparator | Placebo to match XmA5871 administered by IV infusion for up to a total of 16 infusions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XmAb5871 | Biological |
| ||
| Placebo to match XmAb5871 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Without Loss of Systemic Lupus Erythematosus Disease Activity Improvement on Day 225 | Landmark proportion of patients without loss of systemic lupus erythematosus disease activity improvement on Day 225 | Day 225 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Without Loss of Systemic Lupus Erythematosus Disease Activity Improvement on Day 169 | Landmark proportion of patients without loss of systemic lupus erythematosus disease activity improvement on Day 169 | Day 169 |
| Time to Loss of Systemic Lupus Erythematosus Disease Activity Improvement Achieved by a Short Period of IM Steroid Therapy in SLE Patients |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC San Diego | La Jolla | California | 92037 | United States | ||
| Loma Linda University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1599520 | Background | Bombardier C, Gladman DD, Urowitz MB, Caron D, Chang CH. Derivation of the SLEDAI. A disease activity index for lupus patients. The Committee on Prognosis Studies in SLE. Arthritis Rheum. 1992 Jun;35(6):630-40. doi: 10.1002/art.1780350606. | |
| 11838846 | Background | Gladman DD, Ibanez D, Urowitz MB. Systemic lupus erythematosus disease activity index 2000. J Rheumatol. 2002 Feb;29(2):288-91. |
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After obtaining informed consent, IM depomedrol was administered and screening studies were performed over the 2-4 week screening period. Immunosuppressive therapy must have been stopped or tapered off by randomization on Day 1. Patients who did not meet the disease activity improvement criteria during the screening period were not randomized.
First informed consent date: 16FEB2016 First randomization date: 07MAR2016 Last informed consent date: 09NOV2017 Last randomization date: 07DEC2017
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| ID | Title | Description |
|---|---|---|
| FG000 | XmAb5871 | XmAb5871 administered by IV infusion for up to a total of 16 infusions |
| FG001 | Placebo | Placebo to match XmA5871 administered by IV infusion for up to a total of 16 infusions |
| 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 | Jul 29, 2016 | May 9, 2019 |
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Randomized (1:1, no stratification), Double-Blinded, Placebo-Controlled
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Loss of improvement was defined as worsening of disease activity that in the opinion of the principal investigator requires a change in treatment (exclusive of a decrease in oral steroids) AND one of:
|
| From the date of randomization until the date of loss of Systemic Lupus Erythematosus Disease Activity Improvement, or the date of the final efficacy assessment, up to 239 days. |
| Loma Linda |
| California |
| 92354 |
| United States |
| East Bay Rheumatology Medical Group | San Leandro | California | 94578 | United States |
| Yale University School of Medicine | New Haven | Connecticut | 06250 | United States |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Center For Rheumatology | Fort Lauderdale | Florida | 33309 | United States |
| Piedmont Atlanta Rheumatology | Atlanta | Georgia | 30309 | United States |
| Emory University School of Medicine | Atlanta | Georgia | 30322 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Joshua P June, DO | Lansing | Michigan | 48910 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Suny Downstate Medical Center | Brooklyn | New York | 11203 | United States |
| Feinstein Institute for Medical Research | Manhasset | New York | 11030 | United States |
| NYU Langone Medical Center | New York | New York | 10016 | United States |
| Hospital for Special Surgery | New York | New York | 10021 | United States |
| Columbia University Medical Center | The Bronx | New York | 10461 | United States |
| CTRC University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27517 | United States |
| DJL Clinical Research | Charlotte | North Carolina | 28210 | United States |
| Paramount Medical Research and Consulting LLC | Cleveland | Ohio | 44130 | United States |
| Arthritis & Rheumatology Center of Oklahoma, PLLC | Oklahoma City | Oklahoma | 73103 | United States |
| Oklahoma Center for Arthritis Therapy & Research | Tulsa | Oklahoma | 74104 | United States |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| 37459248 | Derived | Merrill JT, Guthridge J, Smith M, June J, Koumpouras F, Machua W, Askanase A, Khosroshahi A, Sheikh SZ, Rathi G, Burington B, Foster P, Matijevic M, Arora S, Wang X, Gao M, Wax S, James JA, Zack DJ. Obexelimab in Systemic Lupus Erythematosus With Exploration of Response Based on Gene Pathway Co-Expression Patterns: A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Trial. Arthritis Rheumatol. 2023 Dec;75(12):2185-2194. doi: 10.1002/art.42652. |
| COMPLETED |
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| NOT COMPLETED |
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Intent to Treat (ITT) Population: All patients who have received at least a partial dose of XmAb5871 or placebo. One patient was randomized to XmAb5871 but was never treated and withdrew from the study. This one patient is excluded from this analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | XmAb5871 | XmAb5871 administered by IV infusion for up to a total of 16 infusions |
| BG001 | Placebo | Placebo to match XmA5871 administered by IV infusion for up to a total of 16 infusions |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | 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 |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| SLEDAI Total Score at Screening--Efficacy Evaluable Population | The Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) total score ranges between 0 and 105. The higher the score, the more significant is the degree of disease activity. Scores of 6 and above are considered to be consistent with active disease requiring therapy. | Efficacy Evaluable Population: All patients who:
| Median | Full Range | units 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 | Percentage of Patients Without Loss of Systemic Lupus Erythematosus Disease Activity Improvement on Day 225 | Landmark proportion of patients without loss of systemic lupus erythematosus disease activity improvement on Day 225 | Efficacy Evaluable Population: All patients who:
| Posted | Count of Participants | Participants | Day 225 |
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Without Loss of Systemic Lupus Erythematosus Disease Activity Improvement on Day 169 | Landmark proportion of patients without loss of systemic lupus erythematosus disease activity improvement on Day 169 | Efficacy Evaluable Population: All patients who:
| Posted | Count of Participants | Participants | Day 169 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Loss of Systemic Lupus Erythematosus Disease Activity Improvement Achieved by a Short Period of IM Steroid Therapy in SLE Patients | Loss of improvement was defined as worsening of disease activity that in the opinion of the principal investigator requires a change in treatment (exclusive of a decrease in oral steroids) AND one of:
| Efficacy Evaluable Population: All patients who:
| Posted | Median | 95% Confidence Interval | days | From the date of randomization until the date of loss of Systemic Lupus Erythematosus Disease Activity Improvement, or the date of the final efficacy assessment, up to 239 days. |
|
Adverse event summaries include events reported between randomization and the end of study visit (Day 253)
Adverse events were reported by study center investigators using an electronic data capture system.
Safety Population: All patients who have received at least a partial dose of XmAb5871 or placebo.
One patient was randomized to XmAb5871 but was never treated and withdrew from the study. This one patient is excluded from adverse event summaries.
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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 | XmAb5871 | XmAb5871 administered by IV infusion for up to a total of 16 infusions | 0 | 52 | 7 | 52 | 41 | 52 |
| EG001 | Placebo | Placebo to match XmA5871 administered by IV infusion for up to a total of 16 infusions | 0 | 52 | 4 | 52 | 28 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 21.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA version 21.0 | Systematic Assessment |
| |
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 21.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 21.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 21.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA version 21.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA version 21.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA version 21.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA version 21.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA version 21.0 | Systematic Assessment |
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| Flushing | Vascular disorders | MedDRA version 21.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA version 21.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 21.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA version 21.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 21.0 | Systematic Assessment |
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| Acute sinusitis | Infections and infestations | MedDRA version 21.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 21.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA version 21.0 | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA version 21.0 | Systematic Assessment |
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| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA version 21.0 | Systematic Assessment |
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| Peripheral swelling | General disorders | MedDRA version 21.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA version 21.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA version 21.0 | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA version 21.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA version 21.0 | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA version 21.0 | Systematic Assessment |
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| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.0 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA version 21.0 | Systematic Assessment |
|
Prior to database lock, an evaluation of early discontinuation rates indicated that the efficacy-evaluable population might be insufficient to power the primary analysis. An additional 15 patients were enrolled beyond the originally planned 90.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Biometrics | Xencor, Inc. | 858-480-3414 | bburington@xencor.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 2, 2018 | May 9, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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