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This study evaluates the impact of 13 bi-weekly intravenous infusions of RSLV-132 on the cutaneous manifestations in subjects with systemic lupus erythematosus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RSLV-132 | Experimental | 10 mg/kg RSLV-132 |
|
| Placebo | Placebo Comparator | Saline placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RSLV-132 | Drug | RNase-Fc fusion protein |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Improvement Compared to Placebo. | Mean change from baseline (from baseline to Day 85; or baseline to Day 169) in CLASI activity scores (Last Observation Carried Forward [LOCF] post censoring values). The CLASI is a single-page tool that separately quantifies disease activity and damage. For the activity score, points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. The total score represents the sum of the individual scores and ranges from 0 to 70. Higher scores are awarded for more severe manifestations. | Baseline and Days 29, 57, 85, 99, 113, 127, 141, 155, 169 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving a 50% Improvement in CLASI Activity Score | Percentage of participants achieving a 50% improvement in CLASI activity score at Day 85 and Day 169 (LOCF post censoring due to use of exclusionary medications) | Baseline and Days 29, 57, 85, 99, 113, 127, 141, 155, 169 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Posada, Ph.D. | Resolve Therapeutics | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TriWest Research Associates | El Cajon | California | 92020 | United States | ||
| University of California San Diego |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33687069 | Derived | Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | RSLV-132 | 10 mg/kg RSLV-132 RSLV-132: RNase-Fc fusion protein |
| FG001 | Placebo | Saline placebo Placebo: Saline 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 | Apr 27, 2017 | Nov 23, 2020 |
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| Drug |
Saline placebo |
|
| La Jolla |
| California |
| 92093 |
| United States |
| Valerius Research Center | Los Alamitos | California | 90720 | United States |
| Wallace Rheumatic Study Center | Los Angeles | California | 90048 | United States |
| University of Colorado | Aurora | Colorado | 80045 | United States |
| Clinical Research of West Florida | Clearwater | Florida | 33765 | United States |
| Center for Rheumatology, Immunology and Arthritis | Fort Lauderdale | Florida | 33309 | United States |
| Alper Research | Naples | Florida | 34102 | United States |
| Northwell Health/ Division of Rheumatology | Great Neck | New York | 11042 | United States |
| Feinstein Institute for Medical Research | Manhasset | New York | 11030 | United States |
| DJL Clinical Research | Charlotte | North Carolina | 28210 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Temple University | Philadelphia | Pennsylvania | 19140 | United States |
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
| Metroplex Clinical Research Center | Dallas | Texas | 75231 | United States |
| Accurate Clinical Research | Sugar Land | Texas | 77479 | United States |
| COMPLETED |
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| NOT COMPLETED |
|
|
All participants who received at least one dose of study treatment
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| ID | Title | Description |
|---|---|---|
| BG000 | RSLV-132 | 10 mg/kg RSLV-132 RSLV-132: RNase-Fc fusion protein |
| BG001 | Placebo | Saline placebo Placebo: Saline placebo |
| 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| CLASI Activity Total Score | Mean Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score. The CLASI is a single-page tool that separately quantifies disease activity and damage. For the activity score, points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. The total score represents the sum of the individual scores and ranges from 0 to 70. Higher scores are awarded for more severe manifestations. | Mean | Standard Deviation | Score on a scale |
| ||||||||||||||
| Oral corticosteroid dose | 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 | Mean Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Improvement Compared to Placebo. | Mean change from baseline (from baseline to Day 85; or baseline to Day 169) in CLASI activity scores (Last Observation Carried Forward [LOCF] post censoring values). The CLASI is a single-page tool that separately quantifies disease activity and damage. For the activity score, points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. The total score represents the sum of the individual scores and ranges from 0 to 70. Higher scores are awarded for more severe manifestations. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and Days 29, 57, 85, 99, 113, 127, 141, 155, 169 |
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| Secondary | Percentage of Participants Achieving a 50% Improvement in CLASI Activity Score | Percentage of participants achieving a 50% improvement in CLASI activity score at Day 85 and Day 169 (LOCF post censoring due to use of exclusionary medications) | On Day 169, a post hoc exploratory subgroup analysis was performed on participants with severe CLASI and severe SLE Disease Activity Index (SLEDAI-2K) scores at baseline. The SLEDAI-2K is a clinical index for the assessment of lupus disease activity in the previous 30 days. It consists of 24 weighted clinical and laboratory variables of nine organ systems. Scores of the descriptors range from 1 to 8, the total possible score is 105. A higher score indicates more severe disease. | Posted | Count of Participants | Participants | Baseline and Days 29, 57, 85, 99, 113, 127, 141, 155, 169 |
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| Post-Hoc | Percentage of Participants With SRI-4 Response | Percentage of participants with an Systemic Lupus Erythematous Responder Index (SRI) 4 response on Day 169. This is a composite responder index incorporating the British Isles Lupus Assessment Group (BILAG) 2004, SLEDAI-2K and Physician Global Assessment (PGA) responses. The BILAG-2004 index, an organ-based transitional activity instrument, provides disease activity scorings across nine organ systems (constitutional, mucocutaneous, neuropsychiatry, musculoskeletal, cardiorespiratory, gastrointestinal, ophthalmic, renal and hematological) on an ordinal scale (A to E) based on the physician's intention-to-treat premise. Grade A represents the most active and Grade E the least active disease. The Physician's Global Assessment is measured on a 0 to 100 mm scale with score 0 to be No Disease Activity and score 100 to be the most Severe Disease Activity. | A subgroup analysis was also performed on participants with severe CLASI and severe SLEDAI scores | Posted | Count of Participants | Participants | Baseline and Day 169 |
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| Post-Hoc | Percentage of Participants With a British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) Response | Percentage of participants with a BICLA response on Day 169. This is a composite responder index incorporating the BILAG-2004, SLEDAI-2K and PGA responses. The BILAG-2004 index, an organ-based transitional activity instrument, provides disease activity scorings across nine organ systems (constitutional, mucocutaneous, neuropsychiatry, musculoskeletal, cardiorespiratory, gastrointestinal, ophthalmic, renal and hematological) on an ordinal scale (A to E) based on the physician's intention-to-treat premise. Grade A represents the most active and Grade E the least active disease. The PGA is measured on a 0 to 100 mm scale with score 0 to be No Disease Activity and score 100 to be the most Severe Disease Activity. | A subgroup analysis was also performed on participants with severe CLASI and severe SLEDAI scores | Posted | Count of Participants | Participants | Baseline and Day 169 |
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|
215 days
Treatment emergent adverse events are summarized
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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 | RSLV-132 | 10 mg/kg RSLV-132 RSLV-132: RNase-Fc fusion protein | 0 | 42 | 3 | 42 | 36 | 42 |
| EG001 | Placebo | Saline placebo Placebo: Saline placebo | 0 | 22 | 5 | 22 | 20 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Escherichia Sepsis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Flank Pain | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Systemic Lupus Erythematosus | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cutaneous Lupus Erythematosus | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Cutaneous Lupus Erythematosus | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Systemic Lupus Erythematosus | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Posada | Resolve Therapeutics LLC | (208)7277010 | jp@resolvebio.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 10, 2020 | Nov 24, 2020 | 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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| ID | Term |
|---|---|
| C000626691 | RSLV-132 |
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| Male |
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| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| >0 and less than or equal to 7.5 mg/kg |
|
| >7.5 |
|
Change from baseline at Day 169 RSLV-132 versus placebo
| t-test, 2 sided |
| 0.818 |
| Mean Difference (Final Values) |
| -0.48 |
| 2-Sided |
| 95 |
| -4.66 |
| 3.70 |
| Superiority |
Two-sample t-test with Satterthwaite approximation |
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| Units |
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| Counts |
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| Participants |
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| Participants |
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