Lupus, SLE, Systemic Lupus Erythematosus
Conditions
Keywords
JBT-101 (also known as lenabasum), efficacy, musculoskeletal disease, randomized trial
Brief summary
The objective of this study is to evaluate the efficacy, safety, and tolerability of JBT-101 (also known as lenabasum) in systemic lupus erythematosus (SLE). * One hundred adults with active joint disease and at least moderate pain will be enrolled in this study to evaluate treatment of their systemic lupus erythematosus (SLE) with JBT-101. JBT-101 is a synthetic endocannabinoid receptor type 2 (CB2) agonist and an activator of the body's normal processes, to resolve innate immune responses without immunosuppression. * Participants will receive 2 doses of JBT-101 by mouth (three groups of varying doses) or, placebo, for 84 days and will continue to be followed for an additional 28 days. Participant visits to assess endpoints occur on Day 1, then every 2 weeks twice, then every 4 weeks three times, for a total of six visits. * The change in maximum daily pain Numerical Rating Scale (NRS) score from Baseline (Visit 1) will be assessed at every visit.
Interventions
DRUGJBT-101
Participants will self-administer JBT-101 by mouth (orally), at prescribed dose and frequency per protocol, Days 1-84. Administration of dose(s) should be at least 8 hours apart.
DRUGPlacebo
Participants will self-administer JBT-101 placebo by mouth (orally), at prescribed dose and frequency per protocol, Days 1-84. Administration of dose(s) should be at least 8 hours apart.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Corbus Pharmaceuticals Inc.
Autoimmunity Centers of Excellence
Rho Federal Systems Division, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Fulfills the updated American College of Rheumatology (ACR) 1982 Revised Criteria for the Classification of Systemic Lupus Erythematosus; * At least 3 months of treatment with an anti-malarial drug such as hydroxychloroquine or a history of intolerance, contraindication, or unwillingness to take an anti-malarial drug; * Meets the Safety of Estrogen in Lupus: National Assessment (SELENA) Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) definition of arthritis (Petri et al., 1999) or mild/moderate arthritis or tendonitis scored as a BILAG B on the updated BILAG 2004; * Seven-day average of maximum of daily pain Numerical Rating Scale (NRS) scores ≥ 4 out of 10; * Overlap with polymyositis, systemic sclerosis, Sjögren's syndrome, or rheumatoid arthritis is allowed, if, in the site investigator's judgment, the predominant clinical features are those of Systemic Lupus Erythematosus (SLE); * Not expected by the site investigator to require a change in potential disease- modifying treatments for SLE from Screening through Visit 6 (Day 112); * Willing to not start nor stop any Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or potential disease-modifying medications or supplements for SLE from Screening through Visit 6 (Day 112), unless a change is recommended by the site investigator or other treating physicians; * Willing not to use any legal or illegal cannabinoids, including Food and Drug Administration (FDA)-approved cannabinoids or cannabinoid-mimic drugs, or any illegal substance of abuse from Screening through Visit 6 (Day 112); * If a woman of child-bearing potential, willing to use one of the highly effective (failure rate \< 1% per year) birth control method from Screening through Visit 6 (Day 112) or for 28 ± 3 days after the last dose of study product; and * Willing to follow instructions, complete study procedures and attend study visits as required by this protocol.
Exclusion criteria
* Severe or unstable Systemic lupus erythematosus (SLE), such as any one of the following: * A British Isles Lupus Activity Group (BILAG) A score in one or more BILAG domains at Screening; * Treatment with any intraarticular, intravenous, or intramuscular systemic corticosteroids within 14 days of Screening; * Treatment with oral prednisone \> 10 mg per day or \> 20 mg every other day (or equivalent dose of another corticosteroid) within 14 days of Screening; * Increased dose of systemic corticosteroids in the 14 days prior to Screening; * Treatment with cyclophosphamide or anti-TNFalpha biologic agents within 3 months before Visit 1 (Day 1); * Treatment with B cell-depleting monoclonal antibodies (rituximab, Ocrelizumab, anti-CD22) within 6 months before Visit 1 (Day 1); * Treatment with methotrexate, mycophenolate, azathioprine, leflunomide, cyclosporine, belimumab, tacrolimus, or any other immunosuppressive agent not included in 2b.-d. above, when the dose of that immunosuppressive agent has increased within 3 months before Visit 1. Concurrent treatment with any of these medications is allowed as long as the doses have been stable for at least 3 months before Visit 1 (Day 1); or * Actively listed on an organ transplantation list or have received an organ transplant other than a corneal transplant. * Significant diseases or conditions other than SLE that may influence response to the study product or safety, such as: * Active bacterial or viral infection requiring systemic antibiotic or anti-viral treatment within 14 days before Visit 1 (Day 1); * Acute or chronic hepatitis B or C infection; * Human immunodeficiency infection (HIV); * History of active tuberculosis or positive tuberculosis skin or blood test without: 1) completing a course of appropriate treatment; or ) having received at least one month of appropriate treatment prior to Visit 1 (Day 1) and continuing to receive appropriate treatment during the study; * No elective surgery should be planned from Visit 1 (Day 1) through Visit 6 (Day 112); or * A history of cancer except basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy greater than one year before Visit 1 (Day 1). * Significant heart disease as defined by: * Uncontrollable congestive heart failure, unstable angina, unstable atherosclerotic cardiovascular disease, significant arrhythmia requiring chronic therapy, pulmonary arterial hypertension with dyspnea, disability rated as New York heart Association Grade III or higher, severe systemic hypertension or severe peripheral vascular disease; * Marked baseline prolongation of QT/QTc interval (i.e. repeated demonstration of a QTc interval ≥ 450 msec for males and ≥470 msec for females); * History of risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of long QT/QTc syndrome); or * Clinically significant confirmed abnormality, as determined by the site investigator or qualified designee, on 12-lead Electrocardiogram (ECG) at Screening or Visit 1 (Day 1) before dosing. * History of chronic pain requiring treatment with narcotic analgesia for more than 14 days total within 6 months of baseline. This does not include self-limited pain associated with identifiable events such as surgery; * Current evidence of alcohol abuse (defined as 4 or more drinks per day on at least 4 days of the week) or history of abuse of illegal and/or legally prescribed drugs such as barbiturates, benzodiazepines, amphetamines, cocaine, or opioids during the 1 year prior to Screening; * Currently pregnant, breast-feeding, or lactating; * Any investigational agent within 30 days or five therapeutic half-lives of that agent whichever is longer, before Visit 1 (Day 1); * Any of the following values for laboratory tests at Screening: * A positive pregnancy test (also at Visit 1); * A newly positive QuantiFERON(R) blood test for tuberculosis, without: 1) completing a course of appropriate treatment; or ) having received at least one month of appropriate treatment prior to Visit 1 and continuing to receive appropriate treatment during the study. If the subject has a previous documented positive tuberculosis skin, then this testing does not need to be repeated. If the subject has a documented negative test result within the last year, testing does not need to be repeated, at the discretion of the site investigator. * Hemoglobin \< 8 g/dL; * Neutrophils \< 1.0 x 10\^9/L; * Platelets \< 75 x 10\^9/L; * Estimated Glomerular Filtration Rate (eGFR) \< 50 ml/min according to Cockcroft-Gault equation; * Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase \> 2.0 x upper limit of normal; or * Total bilirubin ≥ 1.5 x upper limit of normal. * Any other conditions that, in the opinion of the site investigator, are clinically significant and may put the subject at greater safety risk, influence response to study product, or interfere with study assessments. When in doubt, the site investigator or qualified designee should discuss the situation with the Protocol Chairs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in the Maximum Daily NRS-Pain Score at Day 84 | Day 1 through Day 84 | The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain. Participants will be asked to report their maximum daily pain using the NRS-Pain. Participants will call into an interactive voice response e diary system (IVRS) and record the number that best reflects their maximum amount of pain experienced in the last 24 hours. Participants will be asked to call at the same time each day, preferably before bedtime. Longitudinal trends over the course of the treatment period will be modeled and used to estimate difference between means at baseline and Day 84 for each treatment group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Had 100% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85 - Last Day of Treatment) and Visit 6 (Day 113) | The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain. The percent change from baseline in the 7-day average of the maximum NRS-Pain scores prior to study Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed. |
| Change From Baseline in Physician Assessed Tender Joint Count | Baseline, (Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment | The change from baseline in the number of tender joints identified by the physician in the Physician Joint Exam at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed. The number of tender joints can range from 0 to 68 joints. |
| Change From Baseline in Physician Assessed Swollen Joint Count | Baseline, (Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment) | The change from baseline in the number of swollen joints identified by the physician in the Physician Joint Exam at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed. The number of swollen joints can range from 0 to 66 joints. |
| Percentage of Participants With Presence of Arthritis in SELENA-SLEDAI | Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85 - Last Day of Treatment) and Visit 6 (Day 113) | The Safety of Estrogen in Lupus National Assessment (SELENA) Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) is a validated tool for assessing SLE disease activity. The percentage of participants with arthritis indicated as Present on the SELENA SLEDAI at Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed. \[A single question on the SELENA SLEDAI with a response of Present or Absent was assessed.\] |
| Percentage of Participants With Improvement From Baseline in Arthritis in BILAG-2004 | Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85 - Last Day of Treatment) and Visit 6 (Day 113) | The BILAG-2004\* is a validated index for assessing SLE disease activity. The BILAG-2004 includes 97 clinical and laboratory items to evaluate SLE disease activity in 9 organ systems. The severity of arthritis at baseline will be determine by the highest arthritis severity level where arthritis is indicated as improving, same, new or worse\* BILAG-2004: British Isles Lupus Assessment Group 2004. The percentage of participants who met the criteria for improvement of arthritis in the BILAG-2004 Musculoskeletal assessments (using the mild, moderate and severe arthritis questions on the assessment) at Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed. |
| Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Visit 1 (Baseline) | The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain. |
| Change From Baseline in the Improvement Pain Category Prior to Study Visits | Visit 3 (Day 29) | The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain. The Improvement Pain Category is the change in the pain category from baseline to the post-baseline visit. An improvement of at least 2 pain categories from baseline is considered major pain improvement; improvement of 1 pain category, improvement; no change in pain category, no change; worsening of at least 1 pain category, worsening. |
| Percentage of Participants Who Had at Least 30% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85 - Last Day of Treatment) and Visit 6 (Day 113) | The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain. The percent change from baseline in the 7-day average of the maximum NRS-Pain scores prior to study Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed. |
| Percentage of Participants Who Had at Least 50% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85 - Last Day of Treatment) and Visit 6 (Day 113) | The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain. The percent change from baseline in the 7-day average of the maximum NRS-Pain scores prior to study Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed. |
| Percentage of Participants as Responders Using the SLE Responder Index (SRI) | Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85 - Last Day of Treatment) and Visit 6 (Day 113) | The SRI is a validated SLE disease activity instrument used to detect clinically meaningful improvement of disease in SLE clinical trials. The SRI is a composite instrument comprised of the SELENA-SLE Disease Activity Index \[SELENA-SLEDAI\], Physician Global Assessment (PGA) and British Isles Lupus Assessment Group (BILAG) 2004. A responder is defined as having at least a 4 point reduction in the SELENA-SLEDAI score, no new BILAG A or no more than 1 new BILAG B domain score, and no increase in the PGA of 0.3 points or more. The percentage of participants who met the criteria for a responder in the SRI at Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed. |
| Change From Baseline in Lupus Disease Activity - SELENA-SLEDAI Score | Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment) | The change from baseline in the SELENA-SLEDAI score at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed. The Safety of Estrogen in Lupus National Assessment (SELENA) Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) is a validated tool for assessing SLE disease activity. The SLEDAI is a one page assessment that contains 24 items scored as present or absent. Each item is assigned a weighted score which is summed to calculate the overall SLEDAI score. SLEDAI score ranges from 0-105 points. Higher scores represent more disease activity, with a score of 6 being considered clinically important and may impact the decision to treat. |
| Change From Baseline in Lupus Disease Activity - Total BILAG-2004 Score | Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment) | For each of the nine domains, a numerical score will be assigned based on the BILAG score as follows: A=12, B=8, C=1 and D/E=0. A single numerical BILAG total score will be calculated for each participant visit as the summation of the numerical scores for each of the nine domains. The BILAG total score can range from 0 to 108, with higher scores indicating more disease activity. The change from baseline in the total BILAG-2004 score at Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed. The BILAG-2004\* is a validated index for assessing SLE disease activity. The BILAG-2004 includes 97 clinical and laboratory items to evaluate SLE disease activity in 9 organ systems. \* BILAG-2004: British Isles Lupus Assessment Group 2004. |
| Change From Baseline in Lupus Disease Activity -Physician's Global Assessment (PGA) Score | Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment) | The change from baseline in the total PGA score at Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed. The PGA utilizes a 0 to 3 visual analogue scale for assessing disease activity in SLE that is anchored by the verbal descriptors as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. An increase of \>=0.3 points is considered worsening of the PGA. |
| Change From Baseline in Lupus Disease Activity- Patient Global Assessment Score | Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85 - Last Day of Treatment) and Visit 6 (Day 113) | The change from baseline in the total Patient Global Assessment score at Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed. The total Patient Global Assessment is performed with a visual analogue scale (0 to 100) in which the participant is asked to indicate how active she/he thinks their disease is. The visual analogue scale is anchored by two descriptors: "not active" (score of 0) and "extremely active" (score of 100). |
| Change in Baseline in PROMIS-29 Short Form Score - Physical Function T-score | Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85 - Last Day of Treatment) | The Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Short Form (Version 2.0) will be used to assess trends over time in this state of health measure. The PROMIS-29 consists of 7 domains related to physical, mental and social health. Raw scores are calculated for each domain and translated into a T-score per the PROMIS-29 scoring guide. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher score represents better functioning for the Physical Function domain. The change from baseline in the PROMIS-29 Physical Function T-score at Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85). |
| Change in Baseline in PROMIS - Anxiety T-Score | Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment) | The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank version 2.0 - Anxiety T-Score will be used to assess trends over time in this health measure. The raw score is calculated for and translated into a T-score per the PROMIS scoring guide. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher score represents worse symptomology for the Anxiety domain. The change from baseline in PROMIS Anxiety Score at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed. |
| Change in Baseline in PROMIS - Depression T-Score | Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment) | The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank version 2.0 - Depression T-Score will be used to assess trends over time in this health measure. The raw score is calculated for and translated into a T-score per the PROMIS scoring guide. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher score represents worse symptomology for the Depression domain. The change from baseline in PROMIS Depression Score at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed. |
| Change in Baseline in PROMIS - Fatigue T-Score | Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment) | The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank version 2.0 - Fatigue T-Score will be used to assess trends over time in this health measure. The raw score is calculated for and translated into a T-score per the PROMIS scoring guide. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher score represents worse symptomology for the Fatigue domain. The change from baseline in PROMIS Fatigue Score at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed. |
| Change in Baseline in PROMIS - Sleep Disturbance T-Score | Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment) | The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank version 2.0 - Sleep Disturbance T-Score will be used to assess trends over time in this health measure. The raw score is calculated for and translated into a T-score per the PROMIS scoring guide. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher score represents worse symptomology for the Sleep Disturbance domain. The change from baseline in PROMIS Sleep Disturbance Score at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed. |
| Change in Baseline in PROMIS - Social Role Satisfaction T-Score | Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment) | The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank version 2.0 - Social Role Satisfaction T-Score will be used to assess trends over time in this health measure. The raw score is calculated for and translated into a T-score per the PROMIS scoring guide. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher score better functioning for the Social Role Satisfaction domain. The change from baseline in PROMIS Social Role Satisfaction Score at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed. |
| Change in Baseline in PROMIS - Pain Interference T-Score | Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment) | The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank version 2.0 - Pain Interference T-Score will be used to assess trends over time in this health measure. The raw score is calculated for and translated into a T-score per the PROMIS scoring guide. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher score represents worse symptomology for the Pain Interference domain. The change from baseline in PROMIS Pain Interference Score at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed. |
| Change in Baseline in PROMIS - Pain Intensity | Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment) | The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank version 2.0 - Pain Intensity will be used to assess trends over time in this health measure. The Pain Intensity on the PROMIS is a single item numerical rating scale where the respondent selects a whole number representing the average pain of the past 7 days ranging from 0 (no pain) to 10 (worst pain imaginable). The change from baseline in PROMIS Pain Intensity Score at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed. |
| Change in Baseline in PROMIS Cognitive Function T-Score | Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment) | The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank version 2.0 - Cognitive Function scale will be used to assess trends over time in this health measure. The raw score is calculated for and translated into a T-score per the PROMIS scoring guide. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher score represents better cognitive function. The change from baseline in PROMIS Cognitive Function Score at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed. |
| Percentage of Participants Indicating Clinical Benefit in Treatment Satisfaction | Visit 5 (Day 85 - Last Day of Treatment) | At the end of treatment, the participant and their physician will complete separately a survey asking what treatment assignment they believe they received (e.g., JBT-101, placebo, or cannot tell), whether the participant received benefit from their assigned treatment and whether the participant or their physician would choose the treatment received. The percentage of participants who responded that they received clinical benefit from the experimental drug treatment at the end of treatment will be assessed. |
| Percentage of Physicians Indicating Participant Clinical Benefit in Treatment Satisfaction | Visit 5 (Day 85 - Last Day of Treatment) | At the end of treatment, the participant and their physician will complete separately a survey asking what treatment assignment they believe they received (e.g., JBT-101, placebo, or cannot tell), whether the participant received benefit from their assigned treatment and whether the participant or their physician would choose the treatment received. The percentage of physicians who responded that the participant received clinical benefit from the experimental drug treatment at the end of treatment will be assessed. |
| Number of Grade 3 or Higher Treatment-emergent Adverse Events (TEAE) Related to Study Product | Day 1 after initiation of study intervention through Day 113 | Treatment-emergent Adverse Events grading will be defined by the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. The number of TEAE will be identified by monitoring participant-reported AEs, vital signs, medical history, physical exams, blood and urine safety tests, 12-lead electrocardiograms, and the Addiction Research Center Inventory-Marijuana (ARCI-M). TEAE are defined as AEs that, in the opinion of the blinded/masked site investigator, are " possibly", "probably" or "definitely" related to the assigned study treatment. |
| Number of Treatment Emergent QTc Prolongation Events | Visit 1 (Baseline, Day 1) and Visit 5 (Day 85 - Last Day of Treatment) | The number of treatment emergent QTc prolongation events will be identified when QTc prolongation \> 500 msec total duration and when the change from Visit 1 (Day 1) QTc interval prior to study drug administration \> 60 msec Twelve-lead ECGs were recorded in triplicate at Screening and Visits 1 (Day 1) and 5 (Day 85). The ECGs were evaluated for medically significant abnormalities and QT/QTc intervals. The QT/QTc intervals were measured at Visit 1 (Day 1) before administration and between 2.5 and 3.5 hours after administration of study product in the clinic, at the time of maximum JBT-101 concentration in the blood. |
| Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI) | Visit 3 (Day 29) | The number of mild/moderate and severe disease flares will be assessed using the SFI instrument to define disease flare(s) and severity. The SELENA SLEDAI Flare Index categorizes disease flares as mild/moderate or severe, based on the highest categories of clinical features recorded or by treatment recommendations by the physician. |
| Number of BILAG-2004 Disease Flares | Visit 3 (Day 29) | The number of BILAG-2004 disease flares as defined as one new BILAG A or two new BILAG B scores will be assessed. The BILAG-2004\* is a validated index for assessing SLE disease activity. The BILAG-2004 includes 97 clinical and laboratory items to evaluate SLE disease activity in 9 organ systems. \* BILAG-2004: British Isles Lupus Assessment Group 2004. |
| Number of Treatment Emergent Events With Elevated Liver Tests | Day 1 through Visit 6 (Day 113) | The number of participants with elevated liver tests, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 3 x upper limit of normal and total bilirubin \> 1.5 x the upper limit of normal, present on repeat testing, at Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed. |
| Number of Treatment Emergent Intolerability Events | Day 1 after initiation of study intervention through Visit 5 (Day 85 - Last Day of Treatment) | The number of intolerability events of the study drug, defined as incidence of discontinuation of study product due to TEAEs at least possibly related to study product from Visits 1 (Day 1) through 5 (Day 85) will be assessed. |
| Percentage of Participants Who Had at Least 75% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits Score | Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85 - Last Day of Treatment) and Visit 6 (Day 113) | The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain. The percent change from baseline in the 7-day average of the maximum NRS-Pain scores prior to study Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed. |
| Percentage of Participants With Increased Scores From Baseline on ARCI-M | Visit 1 (Baseline, Day 1-prior to treatment initiation), Visit 1 (Baseline, Day 1-post-treatment initiation) Visit 3 (Day 29) and Visit 5 (Day 85 - Last Day of Treatment) | The percentage of participants who experienced ≥1 score increase on the ARCI-M from the Visit 1 (Day 1) pre-dose assessment at Visit 1 (Day 1) post-dose, Visit 3 (Day 29) and Visit 5 (Day 85) will be assessed. The ARCI-M questionnaire was completed by subjects at Visit1 (Day 1) pre- and post-dosing, Visit 3 (Day 29) and Visit 5 (Day 85). This is a 12-item true/false questionnaire developed by the National Institutes of Drug Abuse, designed to detect the full range of subjective responses experienced by marijuana users. An answer of true has an assigned value of 1 and an answer of false has an assigned value of 0. The ARCI-M score was computed as the sum of the assigned values for all 12 questions and can range from 0 to 12. If a question is missed, the score is not calculated. |
Countries
United States
Contacts
STUDY_CHAIRMeggan Mackay, M.D., M.S.
Northwell Health
STUDY_CHAIRRobert B. Zurier, M.D.
Northwell Health
Participant flow
Recruitment details
16 study sites were activated in the United States, beginning in December 2017. A total of 148 participants were screened from January 2018 to March 2021 at all 16 sites. 109 participants were randomized.
Participants by arm
| Arm | Count |
|---|---|
| High: JBT-101 20mg/20mg Participants self-administered 20 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84. | 25 |
| Medium: JBT-101 20mg/Placebo Participants self-administered 20 mg of JBT-101 by mouth (orally), in the morning and Placebo in the evening, on Days 1-84. | 27 |
| Low: JBT-101 5mg/5mg Participants self-administered 5 mg of JBT-101 by mouth (orally), twice a day, on Days 1-84. | 24 |
| Placebo Participants self-administered Placebo by mouth (orally), twice a day, on Days 1-84. | 25 |
| Total | 101 |
Baseline characteristics
| Characteristic | High: JBT-101 20mg/20mg | Total | Placebo | Low: JBT-101 5mg/5mg | Medium: JBT-101 20mg/Placebo |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 3 Participants | 0 Participants | 1 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants | 98 Participants | 25 Participants | 23 Participants | 27 Participants |
| Age, Continuous | 48.6 years STANDARD_DEVIATION 12.5 | 44.2 years STANDARD_DEVIATION 11.2 | 44.6 years STANDARD_DEVIATION 9.5 | 43.4 years STANDARD_DEVIATION 12.6 | 40.3 years STANDARD_DEVIATION 8.6 |
| Arthritis Present on SLEDAI Not Present | 2 Participants | 6 Participants | 0 Participants | 1 Participants | 3 Participants |
| Arthritis Present on SLEDAI Present | 23 Participants | 95 Participants | 25 Participants | 23 Participants | 24 Participants |
| Baseline 7-Day Average Maximum Daily Pain NRS, Categorical <4 | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Baseline 7-Day Average Maximum Daily Pain NRS, Categorical >=4 | 25 Participants | 100 Participants | 25 Participants | 23 Participants | 27 Participants |
| Baseline 7-Day Average Pain NRS | 6.6 Score STANDARD_DEVIATION 1.4 | 6.6 Score STANDARD_DEVIATION 1.6 | 6.6 Score STANDARD_DEVIATION 1.6 | 6.6 Score STANDARD_DEVIATION 1.6 | 6.7 Score STANDARD_DEVIATION 1.7 |
| Duration of Systemic Lupus Erythematosus | 11.6 years STANDARD_DEVIATION 8.3 | 11.9 years STANDARD_DEVIATION 9.2 | 11.9 years STANDARD_DEVIATION 10.9 | 10.7 years STANDARD_DEVIATION 7.4 | 13.1 years STANDARD_DEVIATION 10.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 25 Participants | 6 Participants | 6 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 75 Participants | 19 Participants | 18 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Number of Swollen Joints | 5.4 units on a scale STANDARD_DEVIATION 5.2 | 7.2 units on a scale STANDARD_DEVIATION 7.4 | 9.0 units on a scale STANDARD_DEVIATION 8.4 | 6.8 units on a scale STANDARD_DEVIATION 6.6 | 7.6 units on a scale STANDARD_DEVIATION 8.7 |
| Number of Tender and Swollen Joints | 4.1 units on a scale STANDARD_DEVIATION 4.1 | 6.3 units on a scale STANDARD_DEVIATION 7 | 8.3 units on a scale STANDARD_DEVIATION 8.5 | 6.5 units on a scale STANDARD_DEVIATION 6.7 | 6.3 units on a scale STANDARD_DEVIATION 7.8 |
| Number of Tender Joints | 14.1 units on a scale STANDARD_DEVIATION 11.8 | 15.2 units on a scale STANDARD_DEVIATION 12.3 | 18.4 units on a scale STANDARD_DEVIATION 10 | 13.1 units on a scale STANDARD_DEVIATION 9.6 | 15.0 units on a scale STANDARD_DEVIATION 16.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 32 Participants | 8 Participants | 9 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 6 Participants | 1 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 9 Participants | 1 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) White | 14 Participants | 51 Participants | 14 Participants | 8 Participants | 15 Participants |
| Region of Enrollment United States | 25 participants | 101 participants | 25 participants | 24 participants | 27 participants |
| Screening 7-day Average Pain NRS | 6.6 Score STANDARD_DEVIATION 1.4 | 6.6 Score STANDARD_DEVIATION 1.5 | 6.5 Score STANDARD_DEVIATION 1.5 | 6.6 Score STANDARD_DEVIATION 1.4 | 6.7 Score STANDARD_DEVIATION 1.7 |
| Screening 7-day Average Pain NRS, Categorical <=6 | 12 Participants | 50 Participants | 12 Participants | 12 Participants | 14 Participants |
| Screening 7-day Average Pain NRS, Categorical >6 | 13 Participants | 51 Participants | 13 Participants | 12 Participants | 13 Participants |
| Screening Fibromyalgia Symptom Scale Score | 16.8 Scores on a Scale STANDARD_DEVIATION 6.1 | 15.7 Scores on a Scale STANDARD_DEVIATION 6.2 | 16.6 Scores on a Scale STANDARD_DEVIATION 6.3 | 14.2 Scores on a Scale STANDARD_DEVIATION 6 | 15.2 Scores on a Scale STANDARD_DEVIATION 6.2 |
| Screening Fibromyalgia Symptom Scale Score, Categorical <13 | 7 Participants | 29 Participants | 7 Participants | 7 Participants | 8 Participants |
| Screening Fibromyalgia Symptom Scale Score, Categorical >=13 | 18 Participants | 72 Participants | 18 Participants | 17 Participants | 19 Participants |
| SELENA-SLEDAI Score | 6.9 Scores on a Scale STANDARD_DEVIATION 2.7 | 7.4 Scores on a Scale STANDARD_DEVIATION 2.5 | 8.2 Scores on a Scale STANDARD_DEVIATION 2.3 | 7.5 Scores on a Scale STANDARD_DEVIATION 2 | 7.0 Scores on a Scale STANDARD_DEVIATION 2.7 |
| Sex: Female, Male Female | 25 Participants | 95 Participants | 23 Participants | 23 Participants | 24 Participants |
| Sex: Female, Male Male | 0 Participants | 6 Participants | 2 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 27 | 0 / 24 | 0 / 25 |
| other Total, other adverse events | 10 / 25 | 11 / 27 | 16 / 24 | 17 / 25 |
| serious Total, serious adverse events | 1 / 25 | 3 / 27 | 0 / 24 | 2 / 25 |
Outcome results
Primary
Improvement in the Maximum Daily NRS-Pain Score at Day 84
The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain. Participants will be asked to report their maximum daily pain using the NRS-Pain. Participants will call into an interactive voice response e diary system (IVRS) and record the number that best reflects their maximum amount of pain experienced in the last 24 hours. Participants will be asked to call at the same time each day, preferably before bedtime. Longitudinal trends over the course of the treatment period will be modeled and used to estimate difference between means at baseline and Day 84 for each treatment group.
Time frame: Day 1 through Day 84
Population: The modified intent-to-treat population includes all randomized participants who received at least one dose of study drug. One participant, in the Medium: JBT-101 20mg/Placebo treatment, took one dose of drug in clinic and subsequently decided to discontinue treatment and terminate the study. This participant did not report a pain NRS score on Day 1 and is therefore not included in this analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| High: JBT-101 20mg/20mg | Improvement in the Maximum Daily NRS-Pain Score at Day 84 | Day 1 | 6.3 NRS Pain Score |
| High: JBT-101 20mg/20mg | Improvement in the Maximum Daily NRS-Pain Score at Day 84 | Day 84 | 5.1 NRS Pain Score |
| Medium: JBT-101 20mg/Placebo | Improvement in the Maximum Daily NRS-Pain Score at Day 84 | Day 84 | 4.9 NRS Pain Score |
| Medium: JBT-101 20mg/Placebo | Improvement in the Maximum Daily NRS-Pain Score at Day 84 | Day 1 | 6.4 NRS Pain Score |
| Low: JBT-101 5mg/5mg | Improvement in the Maximum Daily NRS-Pain Score at Day 84 | Day 1 | 6.0 NRS Pain Score |
| Low: JBT-101 5mg/5mg | Improvement in the Maximum Daily NRS-Pain Score at Day 84 | Day 84 | 5.1 NRS Pain Score |
| Placebo | Improvement in the Maximum Daily NRS-Pain Score at Day 84 | Day 1 | 6.2 NRS Pain Score |
| Placebo | Improvement in the Maximum Daily NRS-Pain Score at Day 84 | Day 84 | 5.9 NRS Pain Score |
Comparison: The null hypothesis is that linear trends from Day 1 to Day 84 are equivalent for each active JBT-101 cohort and placebo. The overall test is a 3 degree of freedom F test that simultaneously compares the estimated mean change from Day 1 to Day 84 for each of the 3 active JBT-101 cohorts versus placebo.p-value: 0.41995% CI: [-2.5, 0.6]Mixed Models Analysis
Comparison: The null hypothesis is that linear trends from Day 1 to Day 84 are equivalent for each active JBT-101 cohort and placebo. The overall test is a 3 degree of freedom F test that simultaneously compares the estimated mean change from Day 1 to Day 84 for each of the 3 active JBT-101 cohorts versus placebo.p-value: 0.41995% CI: [-2.7, 0.3]Mixed Models Analysis
Comparison: The null hypothesis is that linear trends from Day 1 to Day 84 are equivalent for each active JBT-101 cohort and placebo. The overall test is a 3 degree of freedom F test that simultaneously compares the estimated mean change from Day 1 to Day 84 for each of the 3 active JBT-101 cohorts versus placebo.p-value: 0.41995% CI: [-2.2, 0.8]Mixed Models Analysis
Secondary
Change From Baseline in Lupus Disease Activity- Patient Global Assessment Score
The change from baseline in the total Patient Global Assessment score at Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed. The total Patient Global Assessment is performed with a visual analogue scale (0 to 100) in which the participant is asked to indicate how active she/he thinks their disease is. The visual analogue scale is anchored by two descriptors: not active (score of 0) and extremely active (score of 100).
Time frame: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85 - Last Day of Treatment) and Visit 6 (Day 113)
Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High: JBT-101 20mg/20mg | Change From Baseline in Lupus Disease Activity- Patient Global Assessment Score | Baseline/Day 1 | 60.2 Score | Standard Deviation 22.4 |
| High: JBT-101 20mg/20mg | Change From Baseline in Lupus Disease Activity- Patient Global Assessment Score | Day 29 | 48.1 Score | Standard Deviation 27.6 |
| High: JBT-101 20mg/20mg | Change From Baseline in Lupus Disease Activity- Patient Global Assessment Score | Day 57 | 48.3 Score | Standard Deviation 24 |
| High: JBT-101 20mg/20mg | Change From Baseline in Lupus Disease Activity- Patient Global Assessment Score | Day 85 | 37.0 Score | Standard Deviation 24.8 |
| Medium: JBT-101 20mg/Placebo | Change From Baseline in Lupus Disease Activity- Patient Global Assessment Score | Day 29 | 49.2 Score | Standard Deviation 29.1 |
| Medium: JBT-101 20mg/Placebo | Change From Baseline in Lupus Disease Activity- Patient Global Assessment Score | Day 57 | 50.5 Score | Standard Deviation 29.6 |
| Medium: JBT-101 20mg/Placebo | Change From Baseline in Lupus Disease Activity- Patient Global Assessment Score | Day 85 | 48.0 Score | Standard Deviation 26.2 |
| Medium: JBT-101 20mg/Placebo | Change From Baseline in Lupus Disease Activity- Patient Global Assessment Score | Baseline/Day 1 | 67.0 Score | Standard Deviation 22.1 |
| Low: JBT-101 5mg/5mg | Change From Baseline in Lupus Disease Activity- Patient Global Assessment Score | Day 57 | 50.2 Score | Standard Deviation 28.2 |
| Low: JBT-101 5mg/5mg | Change From Baseline in Lupus Disease Activity- Patient Global Assessment Score | Day 29 | 47.5 Score | Standard Deviation 31.7 |
| Low: JBT-101 5mg/5mg | Change From Baseline in Lupus Disease Activity- Patient Global Assessment Score | Day 85 | 48.7 Score | Standard Deviation 30 |
| Low: JBT-101 5mg/5mg | Change From Baseline in Lupus Disease Activity- Patient Global Assessment Score | Baseline/Day 1 | 65.6 Score | Standard Deviation 20.5 |
| Placebo | Change From Baseline in Lupus Disease Activity- Patient Global Assessment Score | Day 85 | 58.7 Score | Standard Deviation 22.7 |
| Placebo | Change From Baseline in Lupus Disease Activity- Patient Global Assessment Score | Day 29 | 54.4 Score | Standard Deviation 21.7 |
| Placebo | Change From Baseline in Lupus Disease Activity- Patient Global Assessment Score | Baseline/Day 1 | 65.5 Score | Standard Deviation 15 |
| Placebo | Change From Baseline in Lupus Disease Activity- Patient Global Assessment Score | Day 57 | 59.4 Score | Standard Deviation 26 |
Comparison: Each active JBT-101 cohort is compared to placebo.p-value: 0.0795% CI: [-37.24, -5.72]Mixed Models Analysis
Comparison: Each active JBT-101 cohort is compared to placebo.p-value: 0.0795% CI: [-25.33, 4.54]Mixed Models Analysis
Comparison: Each active JBT-101 cohort is compared to placebo.p-value: 0.0795% CI: [-25.78, 4.16]Mixed Models Analysis
Secondary
Change From Baseline in Lupus Disease Activity -Physician's Global Assessment (PGA) Score
The change from baseline in the total PGA score at Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed. The PGA utilizes a 0 to 3 visual analogue scale for assessing disease activity in SLE that is anchored by the verbal descriptors as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. An increase of \>=0.3 points is considered worsening of the PGA.
Time frame: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment)
Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High: JBT-101 20mg/20mg | Change From Baseline in Lupus Disease Activity -Physician's Global Assessment (PGA) Score | Baseline/Day 1 | 1.2 Score | Standard Deviation 0.6 |
| High: JBT-101 20mg/20mg | Change From Baseline in Lupus Disease Activity -Physician's Global Assessment (PGA) Score | Day 29 | 1.2 Score | Standard Deviation 0.6 |
| High: JBT-101 20mg/20mg | Change From Baseline in Lupus Disease Activity -Physician's Global Assessment (PGA) Score | Day 57 | 1.0 Score | Standard Deviation 0.5 |
| High: JBT-101 20mg/20mg | Change From Baseline in Lupus Disease Activity -Physician's Global Assessment (PGA) Score | Day 85 | 0.9 Score | Standard Deviation 0.5 |
| Medium: JBT-101 20mg/Placebo | Change From Baseline in Lupus Disease Activity -Physician's Global Assessment (PGA) Score | Day 29 | 0.9 Score | Standard Deviation 0.6 |
| Medium: JBT-101 20mg/Placebo | Change From Baseline in Lupus Disease Activity -Physician's Global Assessment (PGA) Score | Day 57 | 0.8 Score | Standard Deviation 0.5 |
| Medium: JBT-101 20mg/Placebo | Change From Baseline in Lupus Disease Activity -Physician's Global Assessment (PGA) Score | Day 85 | 0.8 Score | Standard Deviation 0.5 |
| Medium: JBT-101 20mg/Placebo | Change From Baseline in Lupus Disease Activity -Physician's Global Assessment (PGA) Score | Baseline/Day 1 | 1.2 Score | Standard Deviation 0.5 |
| Low: JBT-101 5mg/5mg | Change From Baseline in Lupus Disease Activity -Physician's Global Assessment (PGA) Score | Day 57 | 0.9 Score | Standard Deviation 0.5 |
| Low: JBT-101 5mg/5mg | Change From Baseline in Lupus Disease Activity -Physician's Global Assessment (PGA) Score | Day 29 | 1.0 Score | Standard Deviation 0.6 |
| Low: JBT-101 5mg/5mg | Change From Baseline in Lupus Disease Activity -Physician's Global Assessment (PGA) Score | Day 85 | 0.7 Score | Standard Deviation 0.5 |
| Low: JBT-101 5mg/5mg | Change From Baseline in Lupus Disease Activity -Physician's Global Assessment (PGA) Score | Baseline/Day 1 | 1.4 Score | Standard Deviation 0.4 |
| Placebo | Change From Baseline in Lupus Disease Activity -Physician's Global Assessment (PGA) Score | Day 85 | 0.9 Score | Standard Deviation 0.6 |
| Placebo | Change From Baseline in Lupus Disease Activity -Physician's Global Assessment (PGA) Score | Day 29 | 1.1 Score | Standard Deviation 0.5 |
| Placebo | Change From Baseline in Lupus Disease Activity -Physician's Global Assessment (PGA) Score | Baseline/Day 1 | 1.3 Score | Standard Deviation 0.5 |
| Placebo | Change From Baseline in Lupus Disease Activity -Physician's Global Assessment (PGA) Score | Day 57 | 1.0 Score | Standard Deviation 0.6 |
Comparison: Each active JBT-101 cohort is compared to placebo.p-value: 0.40895% CI: [-0.27, 0.4]Mixed Models Analysis
Comparison: Each active JBT-101 cohort is compared to placebo.p-value: 0.40895% CI: [-0.4, 0.26]Mixed Models Analysis
Comparison: Each active JBT-101 cohort is compared to placebo.p-value: 0.40895% CI: [-0.5, 0.16]Mixed Models Analysis
Secondary
Change From Baseline in Lupus Disease Activity - SELENA-SLEDAI Score
The change from baseline in the SELENA-SLEDAI score at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed. The Safety of Estrogen in Lupus National Assessment (SELENA) Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) is a validated tool for assessing SLE disease activity. The SLEDAI is a one page assessment that contains 24 items scored as present or absent. Each item is assigned a weighted score which is summed to calculate the overall SLEDAI score. SLEDAI score ranges from 0-105 points. Higher scores represent more disease activity, with a score of 6 being considered clinically important and may impact the decision to treat.
Time frame: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment)
Population: mITT -The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High: JBT-101 20mg/20mg | Change From Baseline in Lupus Disease Activity - SELENA-SLEDAI Score | Baseline/Day 1 | 6.9 Scores on a Scale | Standard Deviation 2.7 |
| High: JBT-101 20mg/20mg | Change From Baseline in Lupus Disease Activity - SELENA-SLEDAI Score | Day 29 | 6.1 Scores on a Scale | Standard Deviation 2.2 |
| High: JBT-101 20mg/20mg | Change From Baseline in Lupus Disease Activity - SELENA-SLEDAI Score | Day 57 | 5.4 Scores on a Scale | Standard Deviation 3.4 |
| High: JBT-101 20mg/20mg | Change From Baseline in Lupus Disease Activity - SELENA-SLEDAI Score | Day 85 | 4.7 Scores on a Scale | Standard Deviation 3 |
| Medium: JBT-101 20mg/Placebo | Change From Baseline in Lupus Disease Activity - SELENA-SLEDAI Score | Day 29 | 5.5 Scores on a Scale | Standard Deviation 3.2 |
| Medium: JBT-101 20mg/Placebo | Change From Baseline in Lupus Disease Activity - SELENA-SLEDAI Score | Day 57 | 4.5 Scores on a Scale | Standard Deviation 2.6 |
| Medium: JBT-101 20mg/Placebo | Change From Baseline in Lupus Disease Activity - SELENA-SLEDAI Score | Day 85 | 4.5 Scores on a Scale | Standard Deviation 2.4 |
| Medium: JBT-101 20mg/Placebo | Change From Baseline in Lupus Disease Activity - SELENA-SLEDAI Score | Baseline/Day 1 | 7.0 Scores on a Scale | Standard Deviation 2.7 |
| Low: JBT-101 5mg/5mg | Change From Baseline in Lupus Disease Activity - SELENA-SLEDAI Score | Day 57 | 5.0 Scores on a Scale | Standard Deviation 3.2 |
| Low: JBT-101 5mg/5mg | Change From Baseline in Lupus Disease Activity - SELENA-SLEDAI Score | Day 29 | 6.0 Scores on a Scale | Standard Deviation 2.9 |
| Low: JBT-101 5mg/5mg | Change From Baseline in Lupus Disease Activity - SELENA-SLEDAI Score | Day 85 | 4.5 Scores on a Scale | Standard Deviation 3.1 |
| Low: JBT-101 5mg/5mg | Change From Baseline in Lupus Disease Activity - SELENA-SLEDAI Score | Baseline/Day 1 | 7.5 Scores on a Scale | Standard Deviation 2 |
| Placebo | Change From Baseline in Lupus Disease Activity - SELENA-SLEDAI Score | Day 85 | 5.5 Scores on a Scale | Standard Deviation 3.6 |
| Placebo | Change From Baseline in Lupus Disease Activity - SELENA-SLEDAI Score | Day 29 | 6.6 Scores on a Scale | Standard Deviation 3.2 |
| Placebo | Change From Baseline in Lupus Disease Activity - SELENA-SLEDAI Score | Baseline/Day 1 | 8.2 Scores on a Scale | Standard Deviation 2.3 |
| Placebo | Change From Baseline in Lupus Disease Activity - SELENA-SLEDAI Score | Day 57 | 6.1 Scores on a Scale | Standard Deviation 3.3 |
Comparison: Each active JBT-101 cohort is compared to placebo.p-value: 0.8295% CI: [-2.3, 1.5]Mixed Models Analysis
Comparison: Each active JBT-101 cohort is compared to placebo.p-value: 0.8295% CI: [-2, 1.8]Mixed Models Analysis
Comparison: Each active JBT-101 cohort is compared to placebo.p-value: 0.8295% CI: [-2.6, 1.1]Mixed Models Analysis
Secondary
Change From Baseline in Lupus Disease Activity - Total BILAG-2004 Score
For each of the nine domains, a numerical score will be assigned based on the BILAG score as follows: A=12, B=8, C=1 and D/E=0. A single numerical BILAG total score will be calculated for each participant visit as the summation of the numerical scores for each of the nine domains. The BILAG total score can range from 0 to 108, with higher scores indicating more disease activity. The change from baseline in the total BILAG-2004 score at Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed. The BILAG-2004\* is a validated index for assessing SLE disease activity. The BILAG-2004 includes 97 clinical and laboratory items to evaluate SLE disease activity in 9 organ systems. \* BILAG-2004: British Isles Lupus Assessment Group 2004.
Time frame: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment)
Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High: JBT-101 20mg/20mg | Change From Baseline in Lupus Disease Activity - Total BILAG-2004 Score | Baseline/Day 1 | 12.2 Score | Standard Deviation 5.8 |
| High: JBT-101 20mg/20mg | Change From Baseline in Lupus Disease Activity - Total BILAG-2004 Score | Day 29 | 8.8 Score | Standard Deviation 5.9 |
| High: JBT-101 20mg/20mg | Change From Baseline in Lupus Disease Activity - Total BILAG-2004 Score | Day 57 | 7.9 Score | Standard Deviation 6.4 |
| High: JBT-101 20mg/20mg | Change From Baseline in Lupus Disease Activity - Total BILAG-2004 Score | Day 85 | 8.6 Score | Standard Deviation 5.6 |
| Medium: JBT-101 20mg/Placebo | Change From Baseline in Lupus Disease Activity - Total BILAG-2004 Score | Day 29 | 5.8 Score | Standard Deviation 4.9 |
| Medium: JBT-101 20mg/Placebo | Change From Baseline in Lupus Disease Activity - Total BILAG-2004 Score | Day 57 | 6.5 Score | Standard Deviation 5.5 |
| Medium: JBT-101 20mg/Placebo | Change From Baseline in Lupus Disease Activity - Total BILAG-2004 Score | Day 85 | 5.1 Score | Standard Deviation 5.1 |
| Medium: JBT-101 20mg/Placebo | Change From Baseline in Lupus Disease Activity - Total BILAG-2004 Score | Baseline/Day 1 | 9.7 Score | Standard Deviation 4.8 |
| Low: JBT-101 5mg/5mg | Change From Baseline in Lupus Disease Activity - Total BILAG-2004 Score | Day 57 | 5.4 Score | Standard Deviation 4.8 |
| Low: JBT-101 5mg/5mg | Change From Baseline in Lupus Disease Activity - Total BILAG-2004 Score | Day 29 | 6.2 Score | Standard Deviation 4.3 |
| Low: JBT-101 5mg/5mg | Change From Baseline in Lupus Disease Activity - Total BILAG-2004 Score | Day 85 | 4.9 Score | Standard Deviation 5 |
| Low: JBT-101 5mg/5mg | Change From Baseline in Lupus Disease Activity - Total BILAG-2004 Score | Baseline/Day 1 | 11.5 Score | Standard Deviation 3.6 |
| Placebo | Change From Baseline in Lupus Disease Activity - Total BILAG-2004 Score | Day 85 | 7.7 Score | Standard Deviation 6.2 |
| Placebo | Change From Baseline in Lupus Disease Activity - Total BILAG-2004 Score | Day 29 | 5.5 Score | Standard Deviation 4.3 |
| Placebo | Change From Baseline in Lupus Disease Activity - Total BILAG-2004 Score | Baseline/Day 1 | 13.1 Score | Standard Deviation 4.3 |
| Placebo | Change From Baseline in Lupus Disease Activity - Total BILAG-2004 Score | Day 57 | 8.1 Score | Standard Deviation 5.6 |
Comparison: Each active JBT-101 cohort is compared to placebo.p-value: 0.24495% CI: [-3, 4.4]Mixed Models Analysis
Comparison: Each active JBT-101 cohort is compared to placebo.p-value: 0.24495% CI: [-5.2, 2]Mixed Models Analysis
Comparison: Each active JBT-101 cohort is compared to placebo.p-value: 0.24495% CI: [-6.2, 0.9]Mixed Models Analysis
Secondary
Change From Baseline in Physician Assessed Swollen Joint Count
The change from baseline in the number of swollen joints identified by the physician in the Physician Joint Exam at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed. The number of swollen joints can range from 0 to 66 joints.
Time frame: Baseline, (Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment)
Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High: JBT-101 20mg/20mg | Change From Baseline in Physician Assessed Swollen Joint Count | Baseline/ Day 1 | 5.4 Number of Swollen Joints | Standard Deviation 5.2 |
| High: JBT-101 20mg/20mg | Change From Baseline in Physician Assessed Swollen Joint Count | Day 29 | 5.6 Number of Swollen Joints | Standard Deviation 8.5 |
| High: JBT-101 20mg/20mg | Change From Baseline in Physician Assessed Swollen Joint Count | Day 57 | 3.4 Number of Swollen Joints | Standard Deviation 5.1 |
| High: JBT-101 20mg/20mg | Change From Baseline in Physician Assessed Swollen Joint Count | Day 85 | 3.3 Number of Swollen Joints | Standard Deviation 5.7 |
| Medium: JBT-101 20mg/Placebo | Change From Baseline in Physician Assessed Swollen Joint Count | Day 85 | 3.1 Number of Swollen Joints | Standard Deviation 5.7 |
| Medium: JBT-101 20mg/Placebo | Change From Baseline in Physician Assessed Swollen Joint Count | Day 57 | 3.0 Number of Swollen Joints | Standard Deviation 4.7 |
| Medium: JBT-101 20mg/Placebo | Change From Baseline in Physician Assessed Swollen Joint Count | Day 29 | 4.0 Number of Swollen Joints | Standard Deviation 5 |
| Medium: JBT-101 20mg/Placebo | Change From Baseline in Physician Assessed Swollen Joint Count | Baseline/ Day 1 | 7.6 Number of Swollen Joints | Standard Deviation 8.7 |
| Low: JBT-101 5mg/5mg | Change From Baseline in Physician Assessed Swollen Joint Count | Day 57 | 2.3 Number of Swollen Joints | Standard Deviation 2.8 |
| Low: JBT-101 5mg/5mg | Change From Baseline in Physician Assessed Swollen Joint Count | Day 85 | 2.1 Number of Swollen Joints | Standard Deviation 3 |
| Low: JBT-101 5mg/5mg | Change From Baseline in Physician Assessed Swollen Joint Count | Day 29 | 4.5 Number of Swollen Joints | Standard Deviation 7.2 |
| Low: JBT-101 5mg/5mg | Change From Baseline in Physician Assessed Swollen Joint Count | Baseline/ Day 1 | 6.8 Number of Swollen Joints | Standard Deviation 6.6 |
| Placebo | Change From Baseline in Physician Assessed Swollen Joint Count | Day 29 | 5.3 Number of Swollen Joints | Standard Deviation 7 |
| Placebo | Change From Baseline in Physician Assessed Swollen Joint Count | Baseline/ Day 1 | 9.0 Number of Swollen Joints | Standard Deviation 8.4 |
| Placebo | Change From Baseline in Physician Assessed Swollen Joint Count | Day 85 | 4.0 Number of Swollen Joints | Standard Deviation 4.1 |
| Placebo | Change From Baseline in Physician Assessed Swollen Joint Count | Day 57 | 5.1 Number of Swollen Joints | Standard Deviation 5.7 |
Comparison: Each active JBT-101 cohort is compared to placebo.p-value: 0.55695% CI: [-1.6, 3]Mixed Models Analysis
Comparison: Each active JBT-101 cohort is compared to placebo.p-value: 0.55695% CI: [-2.5, 2]Mixed Models Analysis
Comparison: Each active JBT-101 cohort is compared to placebo.p-value: 0.55695% CI: [-3.1, 1.4]Mixed Models Analysis
Secondary
Change From Baseline in Physician Assessed Tender Joint Count
The change from baseline in the number of tender joints identified by the physician in the Physician Joint Exam at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed. The number of tender joints can range from 0 to 68 joints.
Time frame: Baseline, (Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment
Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High: JBT-101 20mg/20mg | Change From Baseline in Physician Assessed Tender Joint Count | Day 85 | 10.3 Number of Tender Joints | Standard Deviation 13.8 |
| High: JBT-101 20mg/20mg | Change From Baseline in Physician Assessed Tender Joint Count | Day 57 | 9.5 Number of Tender Joints | Standard Deviation 10.5 |
| High: JBT-101 20mg/20mg | Change From Baseline in Physician Assessed Tender Joint Count | Baseline/ Day 1 | 14.1 Number of Tender Joints | Standard Deviation 11.8 |
| High: JBT-101 20mg/20mg | Change From Baseline in Physician Assessed Tender Joint Count | Day 29 | 12.1 Number of Tender Joints | Standard Deviation 13.3 |
| Medium: JBT-101 20mg/Placebo | Change From Baseline in Physician Assessed Tender Joint Count | Day 29 | 12.3 Number of Tender Joints | Standard Deviation 18.5 |
| Medium: JBT-101 20mg/Placebo | Change From Baseline in Physician Assessed Tender Joint Count | Baseline/ Day 1 | 15.0 Number of Tender Joints | Standard Deviation 16.1 |
| Medium: JBT-101 20mg/Placebo | Change From Baseline in Physician Assessed Tender Joint Count | Day 57 | 12.3 Number of Tender Joints | Standard Deviation 20.2 |
| Medium: JBT-101 20mg/Placebo | Change From Baseline in Physician Assessed Tender Joint Count | Day 85 | 11.9 Number of Tender Joints | Standard Deviation 20.2 |
| Low: JBT-101 5mg/5mg | Change From Baseline in Physician Assessed Tender Joint Count | Day 57 | 5.0 Number of Tender Joints | Standard Deviation 6.9 |
| Low: JBT-101 5mg/5mg | Change From Baseline in Physician Assessed Tender Joint Count | Day 85 | 4.7 Number of Tender Joints | Standard Deviation 6 |
| Low: JBT-101 5mg/5mg | Change From Baseline in Physician Assessed Tender Joint Count | Day 29 | 8.8 Number of Tender Joints | Standard Deviation 9.3 |
| Low: JBT-101 5mg/5mg | Change From Baseline in Physician Assessed Tender Joint Count | Baseline/ Day 1 | 13.1 Number of Tender Joints | Standard Deviation 9.6 |
| Placebo | Change From Baseline in Physician Assessed Tender Joint Count | Day 85 | 11.3 Number of Tender Joints | Standard Deviation 11.8 |
| Placebo | Change From Baseline in Physician Assessed Tender Joint Count | Baseline/ Day 1 | 18.4 Number of Tender Joints | Standard Deviation 10 |
| Placebo | Change From Baseline in Physician Assessed Tender Joint Count | Day 29 | 10.0 Number of Tender Joints | Standard Deviation 9 |
| Placebo | Change From Baseline in Physician Assessed Tender Joint Count | Day 57 | 10.7 Number of Tender Joints | Standard Deviation 12.1 |
Comparison: Each active JBT-101 cohort is compared to placebo.p-value: 0.3995% CI: [-4.8, 8.7]Mixed Models Analysis
Comparison: Each active JBT-101 cohort is compared to placebo.p-value: 0.3995% CI: [-4.9, 8.2]Mixed Models Analysis
Comparison: Each active JBT-101 cohort is compared to placebo.p-value: 0.3995% CI: [-8.6, 4.6]Mixed Models Analysis
Secondary
Change From Baseline in the Improvement Pain Category Prior to Study Visits
The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain. The Improvement Pain Category is the change in the pain category from baseline to the post-baseline visit. An improvement of at least 2 pain categories from baseline is considered major pain improvement; improvement of 1 pain category, improvement; no change in pain category, no change; worsening of at least 1 pain category, worsening.
Time frame: Visit 3 (Day 29)
Population: The modified intent-to-treat population includes all randomized participants who received at least one dose of study drug and had data at Visit 3 (Day 29).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| High: JBT-101 20mg/20mg | Change From Baseline in the Improvement Pain Category Prior to Study Visits | Major Improvement | 1 Participants |
| High: JBT-101 20mg/20mg | Change From Baseline in the Improvement Pain Category Prior to Study Visits | Improvement | 7 Participants |
| High: JBT-101 20mg/20mg | Change From Baseline in the Improvement Pain Category Prior to Study Visits | No Change | 13 Participants |
| High: JBT-101 20mg/20mg | Change From Baseline in the Improvement Pain Category Prior to Study Visits | Worsening | 0 Participants |
| Medium: JBT-101 20mg/Placebo | Change From Baseline in the Improvement Pain Category Prior to Study Visits | Improvement | 5 Participants |
| Medium: JBT-101 20mg/Placebo | Change From Baseline in the Improvement Pain Category Prior to Study Visits | No Change | 18 Participants |
| Medium: JBT-101 20mg/Placebo | Change From Baseline in the Improvement Pain Category Prior to Study Visits | Worsening | 0 Participants |
| Medium: JBT-101 20mg/Placebo | Change From Baseline in the Improvement Pain Category Prior to Study Visits | Major Improvement | 1 Participants |
| Low: JBT-101 5mg/5mg | Change From Baseline in the Improvement Pain Category Prior to Study Visits | No Change | 14 Participants |
| Low: JBT-101 5mg/5mg | Change From Baseline in the Improvement Pain Category Prior to Study Visits | Improvement | 7 Participants |
| Low: JBT-101 5mg/5mg | Change From Baseline in the Improvement Pain Category Prior to Study Visits | Worsening | 1 Participants |
| Low: JBT-101 5mg/5mg | Change From Baseline in the Improvement Pain Category Prior to Study Visits | Major Improvement | 1 Participants |
| Placebo | Change From Baseline in the Improvement Pain Category Prior to Study Visits | Worsening | 1 Participants |
| Placebo | Change From Baseline in the Improvement Pain Category Prior to Study Visits | Improvement | 3 Participants |
| Placebo | Change From Baseline in the Improvement Pain Category Prior to Study Visits | Major Improvement | 1 Participants |
| Placebo | Change From Baseline in the Improvement Pain Category Prior to Study Visits | No Change | 20 Participants |
Secondary
Change From Baseline in the Improvement Pain Category Prior to Study Visits
The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain. The Improvement Pain Category is the change in the pain category from baseline to the post-baseline visit. An improvement of at least 2 pain categories from baseline is considered major pain improvement; improvement of 1 pain category, improvement; no change in pain category, no change; worsening of at least 1 pain category, worsening.
Time frame: Visit 5 (Day 85)
Population: The modified intent-to-treat population includes all randomized participants who received at least one dose of study drug and had data at Visit 5 (Day 85).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| High: JBT-101 20mg/20mg | Change From Baseline in the Improvement Pain Category Prior to Study Visits | Major Improvement | 2 Participants |
| High: JBT-101 20mg/20mg | Change From Baseline in the Improvement Pain Category Prior to Study Visits | Improvement | 7 Participants |
| High: JBT-101 20mg/20mg | Change From Baseline in the Improvement Pain Category Prior to Study Visits | No Change | 10 Participants |
| High: JBT-101 20mg/20mg | Change From Baseline in the Improvement Pain Category Prior to Study Visits | Worsening | 0 Participants |
| Medium: JBT-101 20mg/Placebo | Change From Baseline in the Improvement Pain Category Prior to Study Visits | Improvement | 7 Participants |
| Medium: JBT-101 20mg/Placebo | Change From Baseline in the Improvement Pain Category Prior to Study Visits | No Change | 13 Participants |
| Medium: JBT-101 20mg/Placebo | Change From Baseline in the Improvement Pain Category Prior to Study Visits | Worsening | 0 Participants |
| Medium: JBT-101 20mg/Placebo | Change From Baseline in the Improvement Pain Category Prior to Study Visits | Major Improvement | 1 Participants |
| Low: JBT-101 5mg/5mg | Change From Baseline in the Improvement Pain Category Prior to Study Visits | No Change | 11 Participants |
| Low: JBT-101 5mg/5mg | Change From Baseline in the Improvement Pain Category Prior to Study Visits | Improvement | 8 Participants |
| Low: JBT-101 5mg/5mg | Change From Baseline in the Improvement Pain Category Prior to Study Visits | Worsening | 1 Participants |
| Low: JBT-101 5mg/5mg | Change From Baseline in the Improvement Pain Category Prior to Study Visits | Major Improvement | 2 Participants |
| Placebo | Change From Baseline in the Improvement Pain Category Prior to Study Visits | Worsening | 0 Participants |
| Placebo | Change From Baseline in the Improvement Pain Category Prior to Study Visits | Improvement | 2 Participants |
| Placebo | Change From Baseline in the Improvement Pain Category Prior to Study Visits | Major Improvement | 1 Participants |
| Placebo | Change From Baseline in the Improvement Pain Category Prior to Study Visits | No Change | 19 Participants |
Secondary
Change From Baseline in the Improvement Pain Category Prior to Study Visits
The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain. The Improvement Pain Category is the change in the pain category from baseline to the post-baseline visit. An improvement of at least 2 pain categories from baseline is considered major pain improvement; improvement of 1 pain category, improvement; no change in pain category, no change; worsening of at least 1 pain category, worsening.
Time frame: Visit 6 (Day 113)
Population: The modified intent-to-treat population includes all randomized participants who received at least one dose of study drug and had data at Visit 6 (Day 113).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| High: JBT-101 20mg/20mg | Change From Baseline in the Improvement Pain Category Prior to Study Visits | Major Improvement | 0 Participants |
| High: JBT-101 20mg/20mg | Change From Baseline in the Improvement Pain Category Prior to Study Visits | Improvement | 4 Participants |
| High: JBT-101 20mg/20mg | Change From Baseline in the Improvement Pain Category Prior to Study Visits | No Change | 6 Participants |
| High: JBT-101 20mg/20mg | Change From Baseline in the Improvement Pain Category Prior to Study Visits | Worsening | 1 Participants |
| Medium: JBT-101 20mg/Placebo | Change From Baseline in the Improvement Pain Category Prior to Study Visits | Improvement | 5 Participants |
| Medium: JBT-101 20mg/Placebo | Change From Baseline in the Improvement Pain Category Prior to Study Visits | No Change | 9 Participants |
| Medium: JBT-101 20mg/Placebo | Change From Baseline in the Improvement Pain Category Prior to Study Visits | Worsening | 1 Participants |
| Medium: JBT-101 20mg/Placebo | Change From Baseline in the Improvement Pain Category Prior to Study Visits | Major Improvement | 1 Participants |
| Low: JBT-101 5mg/5mg | Change From Baseline in the Improvement Pain Category Prior to Study Visits | No Change | 7 Participants |
| Low: JBT-101 5mg/5mg | Change From Baseline in the Improvement Pain Category Prior to Study Visits | Improvement | 7 Participants |
| Low: JBT-101 5mg/5mg | Change From Baseline in the Improvement Pain Category Prior to Study Visits | Worsening | 0 Participants |
| Low: JBT-101 5mg/5mg | Change From Baseline in the Improvement Pain Category Prior to Study Visits | Major Improvement | 1 Participants |
| Placebo | Change From Baseline in the Improvement Pain Category Prior to Study Visits | Worsening | 0 Participants |
| Placebo | Change From Baseline in the Improvement Pain Category Prior to Study Visits | Improvement | 4 Participants |
| Placebo | Change From Baseline in the Improvement Pain Category Prior to Study Visits | Major Improvement | 0 Participants |
| Placebo | Change From Baseline in the Improvement Pain Category Prior to Study Visits | No Change | 7 Participants |
Secondary
Change From Baseline in the Improvement Pain Category Prior to Study Visits
The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain. The Improvement Pain Category is the change in the pain category from baseline to the post-baseline visit. An improvement of at least 2 pain categories from baseline is considered major pain improvement; improvement of 1 pain category, improvement; no change in pain category, no change; worsening of at least 1 pain category, worsening.
Time frame: Visit 4 (Day 57)
Population: The modified intent-to-treat population includes all randomized participants who received at least one dose of study drug and had data at Visit 4 (Day 57).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| High: JBT-101 20mg/20mg | Change From Baseline in the Improvement Pain Category Prior to Study Visits | Major Improvement | 2 Participants |
| High: JBT-101 20mg/20mg | Change From Baseline in the Improvement Pain Category Prior to Study Visits | Improvement | 5 Participants |
| High: JBT-101 20mg/20mg | Change From Baseline in the Improvement Pain Category Prior to Study Visits | No Change | 10 Participants |
| High: JBT-101 20mg/20mg | Change From Baseline in the Improvement Pain Category Prior to Study Visits | Worsening | 1 Participants |
| Medium: JBT-101 20mg/Placebo | Change From Baseline in the Improvement Pain Category Prior to Study Visits | Improvement | 5 Participants |
| Medium: JBT-101 20mg/Placebo | Change From Baseline in the Improvement Pain Category Prior to Study Visits | No Change | 16 Participants |
| Medium: JBT-101 20mg/Placebo | Change From Baseline in the Improvement Pain Category Prior to Study Visits | Worsening | 0 Participants |
| Medium: JBT-101 20mg/Placebo | Change From Baseline in the Improvement Pain Category Prior to Study Visits | Major Improvement | 2 Participants |
| Low: JBT-101 5mg/5mg | Change From Baseline in the Improvement Pain Category Prior to Study Visits | No Change | 12 Participants |
| Low: JBT-101 5mg/5mg | Change From Baseline in the Improvement Pain Category Prior to Study Visits | Improvement | 9 Participants |
| Low: JBT-101 5mg/5mg | Change From Baseline in the Improvement Pain Category Prior to Study Visits | Worsening | 1 Participants |
| Low: JBT-101 5mg/5mg | Change From Baseline in the Improvement Pain Category Prior to Study Visits | Major Improvement | 0 Participants |
| Placebo | Change From Baseline in the Improvement Pain Category Prior to Study Visits | Worsening | 0 Participants |
| Placebo | Change From Baseline in the Improvement Pain Category Prior to Study Visits | Improvement | 6 Participants |
| Placebo | Change From Baseline in the Improvement Pain Category Prior to Study Visits | Major Improvement | 0 Participants |
| Placebo | Change From Baseline in the Improvement Pain Category Prior to Study Visits | No Change | 17 Participants |
Secondary
Change in Baseline in PROMIS-29 Short Form Score - Physical Function T-score
The Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Short Form (Version 2.0) will be used to assess trends over time in this state of health measure. The PROMIS-29 consists of 7 domains related to physical, mental and social health. Raw scores are calculated for each domain and translated into a T-score per the PROMIS-29 scoring guide. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher score represents better functioning for the Physical Function domain. The change from baseline in the PROMIS-29 Physical Function T-score at Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85).
Time frame: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85 - Last Day of Treatment)
Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High: JBT-101 20mg/20mg | Change in Baseline in PROMIS-29 Short Form Score - Physical Function T-score | Baseline/Day 1 | 37.7 T-Score | Standard Deviation 6.4 |
| High: JBT-101 20mg/20mg | Change in Baseline in PROMIS-29 Short Form Score - Physical Function T-score | Day 29 | 38.5 T-Score | Standard Deviation 7.7 |
| High: JBT-101 20mg/20mg | Change in Baseline in PROMIS-29 Short Form Score - Physical Function T-score | Day 57 | 39.9 T-Score | Standard Deviation 8.2 |
| High: JBT-101 20mg/20mg | Change in Baseline in PROMIS-29 Short Form Score - Physical Function T-score | Day 85 | 39.8 T-Score | Standard Deviation 8.7 |
| Medium: JBT-101 20mg/Placebo | Change in Baseline in PROMIS-29 Short Form Score - Physical Function T-score | Day 29 | 39.8 T-Score | Standard Deviation 6.1 |
| Medium: JBT-101 20mg/Placebo | Change in Baseline in PROMIS-29 Short Form Score - Physical Function T-score | Day 57 | 40.0 T-Score | Standard Deviation 7.7 |
| Medium: JBT-101 20mg/Placebo | Change in Baseline in PROMIS-29 Short Form Score - Physical Function T-score | Day 85 | 41.1 T-Score | Standard Deviation 7.4 |
| Medium: JBT-101 20mg/Placebo | Change in Baseline in PROMIS-29 Short Form Score - Physical Function T-score | Baseline/Day 1 | 39.2 T-Score | Standard Deviation 8.3 |
| Low: JBT-101 5mg/5mg | Change in Baseline in PROMIS-29 Short Form Score - Physical Function T-score | Day 57 | 42.2 T-Score | Standard Deviation 7.8 |
| Low: JBT-101 5mg/5mg | Change in Baseline in PROMIS-29 Short Form Score - Physical Function T-score | Day 29 | 42.1 T-Score | Standard Deviation 7.8 |
| Low: JBT-101 5mg/5mg | Change in Baseline in PROMIS-29 Short Form Score - Physical Function T-score | Day 85 | 41.5 T-Score | Standard Deviation 7.7 |
| Low: JBT-101 5mg/5mg | Change in Baseline in PROMIS-29 Short Form Score - Physical Function T-score | Baseline/Day 1 | 39.2 T-Score | Standard Deviation 6 |
| Placebo | Change in Baseline in PROMIS-29 Short Form Score - Physical Function T-score | Day 85 | 40.3 T-Score | Standard Deviation 7 |
| Placebo | Change in Baseline in PROMIS-29 Short Form Score - Physical Function T-score | Day 29 | 40.5 T-Score | Standard Deviation 8 |
| Placebo | Change in Baseline in PROMIS-29 Short Form Score - Physical Function T-score | Baseline/Day 1 | 38.5 T-Score | Standard Deviation 4.4 |
| Placebo | Change in Baseline in PROMIS-29 Short Form Score - Physical Function T-score | Day 57 | 40.4 T-Score | Standard Deviation 7.6 |
p-value: 0.97995% CI: [-3.38, 3.99]Mixed Models Analysis
p-value: 0.97995% CI: [-3.13, 3.93]Mixed Models Analysis
p-value: 0.97995% CI: [-2.77, 4.31]Mixed Models Analysis
Secondary
Change in Baseline in PROMIS - Anxiety T-Score
The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank version 2.0 - Anxiety T-Score will be used to assess trends over time in this health measure. The raw score is calculated for and translated into a T-score per the PROMIS scoring guide. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher score represents worse symptomology for the Anxiety domain. The change from baseline in PROMIS Anxiety Score at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed.
Time frame: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment)
Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High: JBT-101 20mg/20mg | Change in Baseline in PROMIS - Anxiety T-Score | Baseline/Day 1 | 57.0 T-Score | Standard Deviation 8.6 |
| High: JBT-101 20mg/20mg | Change in Baseline in PROMIS - Anxiety T-Score | Day 29 | 54.7 T-Score | Standard Deviation 11.2 |
| High: JBT-101 20mg/20mg | Change in Baseline in PROMIS - Anxiety T-Score | Day 57 | 55.7 T-Score | Standard Deviation 10 |
| High: JBT-101 20mg/20mg | Change in Baseline in PROMIS - Anxiety T-Score | Day 85 | 52.9 T-Score | Standard Deviation 10.1 |
| Medium: JBT-101 20mg/Placebo | Change in Baseline in PROMIS - Anxiety T-Score | Day 29 | 53.2 T-Score | Standard Deviation 10.3 |
| Medium: JBT-101 20mg/Placebo | Change in Baseline in PROMIS - Anxiety T-Score | Day 57 | 52.6 T-Score | Standard Deviation 11.4 |
| Medium: JBT-101 20mg/Placebo | Change in Baseline in PROMIS - Anxiety T-Score | Day 85 | 50.0 T-Score | Standard Deviation 8.5 |
| Medium: JBT-101 20mg/Placebo | Change in Baseline in PROMIS - Anxiety T-Score | Baseline/Day 1 | 52.4 T-Score | Standard Deviation 10.2 |
| Low: JBT-101 5mg/5mg | Change in Baseline in PROMIS - Anxiety T-Score | Day 57 | 56.0 T-Score | Standard Deviation 9.9 |
| Low: JBT-101 5mg/5mg | Change in Baseline in PROMIS - Anxiety T-Score | Day 29 | 54.1 T-Score | Standard Deviation 7.5 |
| Low: JBT-101 5mg/5mg | Change in Baseline in PROMIS - Anxiety T-Score | Day 85 | 54.7 T-Score | Standard Deviation 9.2 |
| Low: JBT-101 5mg/5mg | Change in Baseline in PROMIS - Anxiety T-Score | Baseline/Day 1 | 56.9 T-Score | Standard Deviation 9.8 |
| Placebo | Change in Baseline in PROMIS - Anxiety T-Score | Day 85 | 53.5 T-Score | Standard Deviation 10.6 |
| Placebo | Change in Baseline in PROMIS - Anxiety T-Score | Day 29 | 51.6 T-Score | Standard Deviation 11.1 |
| Placebo | Change in Baseline in PROMIS - Anxiety T-Score | Baseline/Day 1 | 55.1 T-Score | Standard Deviation 11.4 |
| Placebo | Change in Baseline in PROMIS - Anxiety T-Score | Day 57 | 53.4 T-Score | Standard Deviation 10.8 |
p-value: 0.78895% CI: [-6.14, 3.26]Mixed Models Analysis
p-value: 0.78895% CI: [-6.07, 2.96]Mixed Models Analysis
p-value: 0.78895% CI: [-4, 4.94]Mixed Models Analysis
Secondary
Change in Baseline in PROMIS Cognitive Function T-Score
The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank version 2.0 - Cognitive Function scale will be used to assess trends over time in this health measure. The raw score is calculated for and translated into a T-score per the PROMIS scoring guide. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher score represents better cognitive function. The change from baseline in PROMIS Cognitive Function Score at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed.
Time frame: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment)
Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High: JBT-101 20mg/20mg | Change in Baseline in PROMIS Cognitive Function T-Score | Baseline/Day 1 | 45.5 T-Score | Standard Deviation 8.5 |
| High: JBT-101 20mg/20mg | Change in Baseline in PROMIS Cognitive Function T-Score | Day 29 | 43.6 T-Score | Standard Deviation 9.8 |
| High: JBT-101 20mg/20mg | Change in Baseline in PROMIS Cognitive Function T-Score | Day 57 | 44.7 T-Score | Standard Deviation 7.9 |
| High: JBT-101 20mg/20mg | Change in Baseline in PROMIS Cognitive Function T-Score | Day 85 | 45.0 T-Score | Standard Deviation 8.5 |
| Medium: JBT-101 20mg/Placebo | Change in Baseline in PROMIS Cognitive Function T-Score | Day 29 | 48.3 T-Score | Standard Deviation 10.9 |
| Medium: JBT-101 20mg/Placebo | Change in Baseline in PROMIS Cognitive Function T-Score | Day 57 | 47.1 T-Score | Standard Deviation 10.9 |
| Medium: JBT-101 20mg/Placebo | Change in Baseline in PROMIS Cognitive Function T-Score | Day 85 | 48.1 T-Score | Standard Deviation 10.1 |
| Medium: JBT-101 20mg/Placebo | Change in Baseline in PROMIS Cognitive Function T-Score | Baseline/Day 1 | 45.1 T-Score | Standard Deviation 9.9 |
| Low: JBT-101 5mg/5mg | Change in Baseline in PROMIS Cognitive Function T-Score | Day 57 | 45.6 T-Score | Standard Deviation 9.1 |
| Low: JBT-101 5mg/5mg | Change in Baseline in PROMIS Cognitive Function T-Score | Day 29 | 45.4 T-Score | Standard Deviation 9.2 |
| Low: JBT-101 5mg/5mg | Change in Baseline in PROMIS Cognitive Function T-Score | Day 85 | 45.8 T-Score | Standard Deviation 6.7 |
| Low: JBT-101 5mg/5mg | Change in Baseline in PROMIS Cognitive Function T-Score | Baseline/Day 1 | 42.3 T-Score | Standard Deviation 7.8 |
| Placebo | Change in Baseline in PROMIS Cognitive Function T-Score | Day 85 | 44.2 T-Score | Standard Deviation 11.2 |
| Placebo | Change in Baseline in PROMIS Cognitive Function T-Score | Day 29 | 45.4 T-Score | Standard Deviation 12.4 |
| Placebo | Change in Baseline in PROMIS Cognitive Function T-Score | Baseline/Day 1 | 42.4 T-Score | Standard Deviation 11 |
| Placebo | Change in Baseline in PROMIS Cognitive Function T-Score | Day 57 | 43.4 T-Score | Standard Deviation 10.7 |
Comparison: Each active JBT-101 cohort is compared to placebo.p-value: 0.60895% CI: [-4.45, 3.54]Mixed Models Analysis
Comparison: Each active JBT-101 cohort is compared to placebo.p-value: 0.60895% CI: [-2.27, 5.47]Mixed Models Analysis
Comparison: Each active JBT-101 cohort is compared to placebo.p-value: 0.60895% CI: [-2.25, 5.45]Mixed Models Analysis
Secondary
Change in Baseline in PROMIS - Depression T-Score
The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank version 2.0 - Depression T-Score will be used to assess trends over time in this health measure. The raw score is calculated for and translated into a T-score per the PROMIS scoring guide. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher score represents worse symptomology for the Depression domain. The change from baseline in PROMIS Depression Score at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed.
Time frame: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment)
Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High: JBT-101 20mg/20mg | Change in Baseline in PROMIS - Depression T-Score | Day 85 | 53.0 Score | Standard Deviation 10.6 |
| High: JBT-101 20mg/20mg | Change in Baseline in PROMIS - Depression T-Score | Day 29 | 53.8 Score | Standard Deviation 11.5 |
| High: JBT-101 20mg/20mg | Change in Baseline in PROMIS - Depression T-Score | Day 57 | 52.9 Score | Standard Deviation 10.6 |
| High: JBT-101 20mg/20mg | Change in Baseline in PROMIS - Depression T-Score | Baseline/Day 1 | 57.7 Score | Standard Deviation 10.2 |
| Medium: JBT-101 20mg/Placebo | Change in Baseline in PROMIS - Depression T-Score | Day 29 | 49.1 Score | Standard Deviation 9.6 |
| Medium: JBT-101 20mg/Placebo | Change in Baseline in PROMIS - Depression T-Score | Baseline/Day 1 | 49.6 Score | Standard Deviation 10.1 |
| Medium: JBT-101 20mg/Placebo | Change in Baseline in PROMIS - Depression T-Score | Day 85 | 50.0 Score | Standard Deviation 9.2 |
| Medium: JBT-101 20mg/Placebo | Change in Baseline in PROMIS - Depression T-Score | Day 57 | 49.7 Score | Standard Deviation 10.4 |
| Low: JBT-101 5mg/5mg | Change in Baseline in PROMIS - Depression T-Score | Baseline/Day 1 | 52.7 Score | Standard Deviation 8.8 |
| Low: JBT-101 5mg/5mg | Change in Baseline in PROMIS - Depression T-Score | Day 29 | 49.8 Score | Standard Deviation 7.9 |
| Low: JBT-101 5mg/5mg | Change in Baseline in PROMIS - Depression T-Score | Day 85 | 50.0 Score | Standard Deviation 7.9 |
| Low: JBT-101 5mg/5mg | Change in Baseline in PROMIS - Depression T-Score | Day 57 | 51.8 Score | Standard Deviation 9.1 |
| Placebo | Change in Baseline in PROMIS - Depression T-Score | Baseline/Day 1 | 52.1 Score | Standard Deviation 10 |
| Placebo | Change in Baseline in PROMIS - Depression T-Score | Day 57 | 51.1 Score | Standard Deviation 10.9 |
| Placebo | Change in Baseline in PROMIS - Depression T-Score | Day 29 | 52.0 Score | Standard Deviation 10.9 |
| Placebo | Change in Baseline in PROMIS - Depression T-Score | Day 85 | 50.6 Score | Standard Deviation 10.4 |
p-value: 0.76695% CI: [-6.14, 3.16]Mixed Models Analysis
p-value: 0.76695% CI: [-3.6, 5.11]Mixed Models Analysis
p-value: 0.76695% CI: [-5.55, 3.07]Mixed Models Analysis
Secondary
Change in Baseline in PROMIS - Fatigue T-Score
The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank version 2.0 - Fatigue T-Score will be used to assess trends over time in this health measure. The raw score is calculated for and translated into a T-score per the PROMIS scoring guide. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher score represents worse symptomology for the Fatigue domain. The change from baseline in PROMIS Fatigue Score at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed.
Time frame: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment)
Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High: JBT-101 20mg/20mg | Change in Baseline in PROMIS - Fatigue T-Score | Baseline/Day 1 | 64.0 T-Score | Standard Deviation 7.1 |
| High: JBT-101 20mg/20mg | Change in Baseline in PROMIS - Fatigue T-Score | Day 29 | 61.8 T-Score | Standard Deviation 9.6 |
| High: JBT-101 20mg/20mg | Change in Baseline in PROMIS - Fatigue T-Score | Day 57 | 61.7 T-Score | Standard Deviation 9.2 |
| High: JBT-101 20mg/20mg | Change in Baseline in PROMIS - Fatigue T-Score | Day 85 | 59.7 T-Score | Standard Deviation 11 |
| Medium: JBT-101 20mg/Placebo | Change in Baseline in PROMIS - Fatigue T-Score | Day 29 | 59.6 T-Score | Standard Deviation 11.4 |
| Medium: JBT-101 20mg/Placebo | Change in Baseline in PROMIS - Fatigue T-Score | Day 57 | 57.8 T-Score | Standard Deviation 11.3 |
| Medium: JBT-101 20mg/Placebo | Change in Baseline in PROMIS - Fatigue T-Score | Day 85 | 56.7 T-Score | Standard Deviation 11.8 |
| Medium: JBT-101 20mg/Placebo | Change in Baseline in PROMIS - Fatigue T-Score | Baseline/Day 1 | 62.4 T-Score | Standard Deviation 11.9 |
| Low: JBT-101 5mg/5mg | Change in Baseline in PROMIS - Fatigue T-Score | Day 57 | 55.8 T-Score | Standard Deviation 10.6 |
| Low: JBT-101 5mg/5mg | Change in Baseline in PROMIS - Fatigue T-Score | Day 29 | 58.0 T-Score | Standard Deviation 11.4 |
| Low: JBT-101 5mg/5mg | Change in Baseline in PROMIS - Fatigue T-Score | Day 85 | 57.9 T-Score | Standard Deviation 13.2 |
| Low: JBT-101 5mg/5mg | Change in Baseline in PROMIS - Fatigue T-Score | Baseline/Day 1 | 63.1 T-Score | Standard Deviation 9.9 |
| Placebo | Change in Baseline in PROMIS - Fatigue T-Score | Day 85 | 59.0 T-Score | Standard Deviation 11.3 |
| Placebo | Change in Baseline in PROMIS - Fatigue T-Score | Day 29 | 60.1 T-Score | Standard Deviation 13.4 |
| Placebo | Change in Baseline in PROMIS - Fatigue T-Score | Baseline/Day 1 | 63.7 T-Score | Standard Deviation 9.7 |
| Placebo | Change in Baseline in PROMIS - Fatigue T-Score | Day 57 | 59.4 T-Score | Standard Deviation 11.6 |
p-value: 0.98295% CI: [-6.04, 5.17]Mixed Models Analysis
Comparison: Each active JBT-101 cohort is compared to placebo.p-value: 0.98295% CI: [-6.22, 4.5]Mixed Models Analysis
p-value: 0.98295% CI: [-6.32, 4.36]Mixed Models Analysis
Secondary
Change in Baseline in PROMIS - Pain Intensity
The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank version 2.0 - Pain Intensity will be used to assess trends over time in this health measure. The Pain Intensity on the PROMIS is a single item numerical rating scale where the respondent selects a whole number representing the average pain of the past 7 days ranging from 0 (no pain) to 10 (worst pain imaginable). The change from baseline in PROMIS Pain Intensity Score at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed.
Time frame: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment)
Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High: JBT-101 20mg/20mg | Change in Baseline in PROMIS - Pain Intensity | Baseline/ Day 1 | 6.6 Score | Standard Deviation 1.4 |
| High: JBT-101 20mg/20mg | Change in Baseline in PROMIS - Pain Intensity | Day 29 | 5.5 Score | Standard Deviation 2.1 |
| High: JBT-101 20mg/20mg | Change in Baseline in PROMIS - Pain Intensity | Day 57 | 5.2 Score | Standard Deviation 2.5 |
| High: JBT-101 20mg/20mg | Change in Baseline in PROMIS - Pain Intensity | Day 85 | 4.7 Score | Standard Deviation 2.2 |
| Medium: JBT-101 20mg/Placebo | Change in Baseline in PROMIS - Pain Intensity | Day 29 | 5.3 Score | Standard Deviation 2.4 |
| Medium: JBT-101 20mg/Placebo | Change in Baseline in PROMIS - Pain Intensity | Day 57 | 5.1 Score | Standard Deviation 2.8 |
| Medium: JBT-101 20mg/Placebo | Change in Baseline in PROMIS - Pain Intensity | Day 85 | 5.2 Score | Standard Deviation 2.5 |
| Medium: JBT-101 20mg/Placebo | Change in Baseline in PROMIS - Pain Intensity | Baseline/ Day 1 | 6.9 Score | Standard Deviation 1.7 |
| Low: JBT-101 5mg/5mg | Change in Baseline in PROMIS - Pain Intensity | Day 57 | 4.9 Score | Standard Deviation 2.3 |
| Low: JBT-101 5mg/5mg | Change in Baseline in PROMIS - Pain Intensity | Day 29 | 5.2 Score | Standard Deviation 2.6 |
| Low: JBT-101 5mg/5mg | Change in Baseline in PROMIS - Pain Intensity | Day 85 | 4.6 Score | Standard Deviation 2.6 |
| Low: JBT-101 5mg/5mg | Change in Baseline in PROMIS - Pain Intensity | Baseline/ Day 1 | 7.0 Score | Standard Deviation 1.6 |
| Placebo | Change in Baseline in PROMIS - Pain Intensity | Day 85 | 5.8 Score | Standard Deviation 2.3 |
| Placebo | Change in Baseline in PROMIS - Pain Intensity | Day 29 | 5.8 Score | Standard Deviation 2.1 |
| Placebo | Change in Baseline in PROMIS - Pain Intensity | Baseline/ Day 1 | 6.9 Score | Standard Deviation 1.7 |
| Placebo | Change in Baseline in PROMIS - Pain Intensity | Day 57 | 5.8 Score | Standard Deviation 2.5 |
p-value: 0.24595% CI: [-2.56, 0.29]Mixed Models Analysis
p-value: 0.24595% CI: [-1.93, 0.8]Mixed Models Analysis
p-value: 0.24595% CI: [-2.64, 0.09]Mixed Models Analysis
Secondary
Change in Baseline in PROMIS - Pain Interference T-Score
The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank version 2.0 - Pain Interference T-Score will be used to assess trends over time in this health measure. The raw score is calculated for and translated into a T-score per the PROMIS scoring guide. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher score represents worse symptomology for the Pain Interference domain. The change from baseline in PROMIS Pain Interference Score at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed.
Time frame: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment)
Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High: JBT-101 20mg/20mg | Change in Baseline in PROMIS - Pain Interference T-Score | Baseline/Day 1 | 64.9 Score | Standard Deviation 4.9 |
| High: JBT-101 20mg/20mg | Change in Baseline in PROMIS - Pain Interference T-Score | Day 29 | 61.6 Score | Standard Deviation 7.7 |
| High: JBT-101 20mg/20mg | Change in Baseline in PROMIS - Pain Interference T-Score | Day 57 | 61.1 Score | Standard Deviation 9.4 |
| High: JBT-101 20mg/20mg | Change in Baseline in PROMIS - Pain Interference T-Score | Day 85 | 58.5 Score | Standard Deviation 10.2 |
| Medium: JBT-101 20mg/Placebo | Change in Baseline in PROMIS - Pain Interference T-Score | Day 29 | 61.6 Score | Standard Deviation 8.5 |
| Medium: JBT-101 20mg/Placebo | Change in Baseline in PROMIS - Pain Interference T-Score | Day 57 | 58.5 Score | Standard Deviation 11.2 |
| Medium: JBT-101 20mg/Placebo | Change in Baseline in PROMIS - Pain Interference T-Score | Day 85 | 60.4 Score | Standard Deviation 6.3 |
| Medium: JBT-101 20mg/Placebo | Change in Baseline in PROMIS - Pain Interference T-Score | Baseline/Day 1 | 64.7 Score | Standard Deviation 7.4 |
| Low: JBT-101 5mg/5mg | Change in Baseline in PROMIS - Pain Interference T-Score | Day 57 | 57.7 Score | Standard Deviation 7.9 |
| Low: JBT-101 5mg/5mg | Change in Baseline in PROMIS - Pain Interference T-Score | Day 29 | 60.4 Score | Standard Deviation 8.9 |
| Low: JBT-101 5mg/5mg | Change in Baseline in PROMIS - Pain Interference T-Score | Day 85 | 60.0 Score | Standard Deviation 6.8 |
| Low: JBT-101 5mg/5mg | Change in Baseline in PROMIS - Pain Interference T-Score | Baseline/Day 1 | 65.0 Score | Standard Deviation 7.2 |
| Placebo | Change in Baseline in PROMIS - Pain Interference T-Score | Day 85 | 61.1 Score | Standard Deviation 7.4 |
| Placebo | Change in Baseline in PROMIS - Pain Interference T-Score | Day 29 | 61.2 Score | Standard Deviation 10.9 |
| Placebo | Change in Baseline in PROMIS - Pain Interference T-Score | Baseline/Day 1 | 66.1 Score | Standard Deviation 6.4 |
| Placebo | Change in Baseline in PROMIS - Pain Interference T-Score | Day 57 | 62.0 Score | Standard Deviation 10.3 |
Comparison: Each active JBT-101 cohort is compared to placebo.p-value: 0.65395% CI: [-6, 2.29]Mixed Models Analysis
Comparison: Each active JBT-101 cohort is compared to placebo.p-value: 0.65395% CI: [-3.1, 4.88]Mixed Models Analysis
Comparison: Each active JBT-101 cohort is compared to placebo.p-value: 0.65395% CI: [-4.31, 3.67]Mixed Models Analysis
Secondary
Change in Baseline in PROMIS - Sleep Disturbance T-Score
The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank version 2.0 - Sleep Disturbance T-Score will be used to assess trends over time in this health measure. The raw score is calculated for and translated into a T-score per the PROMIS scoring guide. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher score represents worse symptomology for the Sleep Disturbance domain. The change from baseline in PROMIS Sleep Disturbance Score at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed.
Time frame: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment)
Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High: JBT-101 20mg/20mg | Change in Baseline in PROMIS - Sleep Disturbance T-Score | Baseline/Day 1 | 58.6 Score | Standard Deviation 7.9 |
| High: JBT-101 20mg/20mg | Change in Baseline in PROMIS - Sleep Disturbance T-Score | Day 29 | 56.6 Score | Standard Deviation 7.6 |
| High: JBT-101 20mg/20mg | Change in Baseline in PROMIS - Sleep Disturbance T-Score | Day 57 | 56.0 Score | Standard Deviation 9.7 |
| High: JBT-101 20mg/20mg | Change in Baseline in PROMIS - Sleep Disturbance T-Score | Day 85 | 55.4 Score | Standard Deviation 9.1 |
| Medium: JBT-101 20mg/Placebo | Change in Baseline in PROMIS - Sleep Disturbance T-Score | Day 29 | 54.5 Score | Standard Deviation 8.7 |
| Medium: JBT-101 20mg/Placebo | Change in Baseline in PROMIS - Sleep Disturbance T-Score | Day 57 | 53.7 Score | Standard Deviation 6.6 |
| Medium: JBT-101 20mg/Placebo | Change in Baseline in PROMIS - Sleep Disturbance T-Score | Day 85 | 56.4 Score | Standard Deviation 10.1 |
| Medium: JBT-101 20mg/Placebo | Change in Baseline in PROMIS - Sleep Disturbance T-Score | Baseline/Day 1 | 56.4 Score | Standard Deviation 10.4 |
| Low: JBT-101 5mg/5mg | Change in Baseline in PROMIS - Sleep Disturbance T-Score | Day 57 | 56.4 Score | Standard Deviation 7.6 |
| Low: JBT-101 5mg/5mg | Change in Baseline in PROMIS - Sleep Disturbance T-Score | Day 29 | 57.7 Score | Standard Deviation 8 |
| Low: JBT-101 5mg/5mg | Change in Baseline in PROMIS - Sleep Disturbance T-Score | Day 85 | 56.3 Score | Standard Deviation 7.6 |
| Low: JBT-101 5mg/5mg | Change in Baseline in PROMIS - Sleep Disturbance T-Score | Baseline/Day 1 | 57.9 Score | Standard Deviation 9.1 |
| Placebo | Change in Baseline in PROMIS - Sleep Disturbance T-Score | Day 85 | 57.2 Score | Standard Deviation 8.2 |
| Placebo | Change in Baseline in PROMIS - Sleep Disturbance T-Score | Day 29 | 57.2 Score | Standard Deviation 6.7 |
| Placebo | Change in Baseline in PROMIS - Sleep Disturbance T-Score | Baseline/Day 1 | 62.6 Score | Standard Deviation 7.9 |
| Placebo | Change in Baseline in PROMIS - Sleep Disturbance T-Score | Day 57 | 57.7 Score | Standard Deviation 8.6 |
Comparison: Each active JBT-101 cohort is compared to placebo.p-value: 0.60795% CI: [-4.74, 4.91]Mixed Models Analysis
Comparison: Each active JBT-101 cohort is compared to placebo.p-value: 0.60795% CI: [-1.85, 7.71]Mixed Models Analysis
Comparison: Each active JBT-101 cohort is compared to placebo.p-value: 0.60795% CI: [-3.22, 6.09]Mixed Models Analysis
Secondary
Change in Baseline in PROMIS - Social Role Satisfaction T-Score
The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank version 2.0 - Social Role Satisfaction T-Score will be used to assess trends over time in this health measure. The raw score is calculated for and translated into a T-score per the PROMIS scoring guide. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher score better functioning for the Social Role Satisfaction domain. The change from baseline in PROMIS Social Role Satisfaction Score at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed.
Time frame: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment)
Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High: JBT-101 20mg/20mg | Change in Baseline in PROMIS - Social Role Satisfaction T-Score | Baseline/Day 1 | 42.2 Score | Standard Deviation 5.7 |
| High: JBT-101 20mg/20mg | Change in Baseline in PROMIS - Social Role Satisfaction T-Score | Day 29 | 44.9 Score | Standard Deviation 10.2 |
| High: JBT-101 20mg/20mg | Change in Baseline in PROMIS - Social Role Satisfaction T-Score | Day 57 | 44.2 Score | Standard Deviation 8.1 |
| High: JBT-101 20mg/20mg | Change in Baseline in PROMIS - Social Role Satisfaction T-Score | Day 85 | 46.1 Score | Standard Deviation 9.2 |
| Medium: JBT-101 20mg/Placebo | Change in Baseline in PROMIS - Social Role Satisfaction T-Score | Day 29 | 44.9 Score | Standard Deviation 10.7 |
| Medium: JBT-101 20mg/Placebo | Change in Baseline in PROMIS - Social Role Satisfaction T-Score | Day 57 | 47.1 Score | Standard Deviation 9.2 |
| Medium: JBT-101 20mg/Placebo | Change in Baseline in PROMIS - Social Role Satisfaction T-Score | Day 85 | 48.2 Score | Standard Deviation 10.1 |
| Medium: JBT-101 20mg/Placebo | Change in Baseline in PROMIS - Social Role Satisfaction T-Score | Baseline/Day 1 | 42.5 Score | Standard Deviation 10 |
| Low: JBT-101 5mg/5mg | Change in Baseline in PROMIS - Social Role Satisfaction T-Score | Day 57 | 47.0 Score | Standard Deviation 7.5 |
| Low: JBT-101 5mg/5mg | Change in Baseline in PROMIS - Social Role Satisfaction T-Score | Day 29 | 45.1 Score | Standard Deviation 9.4 |
| Low: JBT-101 5mg/5mg | Change in Baseline in PROMIS - Social Role Satisfaction T-Score | Day 85 | 47.8 Score | Standard Deviation 7.7 |
| Low: JBT-101 5mg/5mg | Change in Baseline in PROMIS - Social Role Satisfaction T-Score | Baseline/Day 1 | 44.3 Score | Standard Deviation 7.3 |
| Placebo | Change in Baseline in PROMIS - Social Role Satisfaction T-Score | Day 85 | 46.8 Score | Standard Deviation 9.9 |
| Placebo | Change in Baseline in PROMIS - Social Role Satisfaction T-Score | Day 29 | 47.3 Score | Standard Deviation 11.4 |
| Placebo | Change in Baseline in PROMIS - Social Role Satisfaction T-Score | Baseline/Day 1 | 42.4 Score | Standard Deviation 7 |
| Placebo | Change in Baseline in PROMIS - Social Role Satisfaction T-Score | Day 57 | 45.9 Score | Standard Deviation 10.3 |
p-value: 0.98195% CI: [-4.66, 4.3]Mixed Models Analysis
p-value: 0.98195% CI: [-3.84, 4.86]Mixed Models Analysis
p-value: 0.98195% CI: [-4.62, 4.08]Mixed Models Analysis
Secondary
Number of BILAG-2004 Disease Flares
The number of BILAG-2004 disease flares as defined as one new BILAG A or two new BILAG B scores will be assessed. The BILAG-2004\* is a validated index for assessing SLE disease activity. The BILAG-2004 includes 97 clinical and laboratory items to evaluate SLE disease activity in 9 organ systems. \* BILAG-2004: British Isles Lupus Assessment Group 2004.
Time frame: Visit 6 (Day 113)
Population: The safety population includes all participants who received at least one dose of study treatment. Number of participants analyzed is number of participants in the safety population with data at the visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High: JBT-101 20mg/20mg | Number of BILAG-2004 Disease Flares | One new BILAG A Flare | 0 Number of Participants |
| High: JBT-101 20mg/20mg | Number of BILAG-2004 Disease Flares | Two new BILAG B Flares | 1 Number of Participants |
| Medium: JBT-101 20mg/Placebo | Number of BILAG-2004 Disease Flares | Two new BILAG B Flares | 0 Number of Participants |
| Medium: JBT-101 20mg/Placebo | Number of BILAG-2004 Disease Flares | One new BILAG A Flare | 0 Number of Participants |
| Low: JBT-101 5mg/5mg | Number of BILAG-2004 Disease Flares | One new BILAG A Flare | 1 Number of Participants |
| Low: JBT-101 5mg/5mg | Number of BILAG-2004 Disease Flares | Two new BILAG B Flares | 0 Number of Participants |
| Placebo | Number of BILAG-2004 Disease Flares | One new BILAG A Flare | 0 Number of Participants |
| Placebo | Number of BILAG-2004 Disease Flares | Two new BILAG B Flares | 0 Number of Participants |
Secondary
Number of BILAG-2004 Disease Flares
The number of BILAG-2004 disease flares as defined as one new BILAG A or two new BILAG B scores will be assessed. The BILAG-2004\* is a validated index for assessing SLE disease activity. The BILAG-2004 includes 97 clinical and laboratory items to evaluate SLE disease activity in 9 organ systems. \* BILAG-2004: British Isles Lupus Assessment Group 2004.
Time frame: Visit 4 (Day 57)
Population: The safety population includes all participants who received at least one dose of study treatment. Number of participants analyzed is number of participants in the safety population with data at the visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High: JBT-101 20mg/20mg | Number of BILAG-2004 Disease Flares | One new BILAG A Flare | 0 Number of Participants |
| High: JBT-101 20mg/20mg | Number of BILAG-2004 Disease Flares | Two new BILAG B Flares | 0 Number of Participants |
| Medium: JBT-101 20mg/Placebo | Number of BILAG-2004 Disease Flares | Two new BILAG B Flares | 0 Number of Participants |
| Medium: JBT-101 20mg/Placebo | Number of BILAG-2004 Disease Flares | One new BILAG A Flare | 0 Number of Participants |
| Low: JBT-101 5mg/5mg | Number of BILAG-2004 Disease Flares | One new BILAG A Flare | 0 Number of Participants |
| Low: JBT-101 5mg/5mg | Number of BILAG-2004 Disease Flares | Two new BILAG B Flares | 1 Number of Participants |
| Placebo | Number of BILAG-2004 Disease Flares | One new BILAG A Flare | 1 Number of Participants |
| Placebo | Number of BILAG-2004 Disease Flares | Two new BILAG B Flares | 0 Number of Participants |
Secondary
Number of BILAG-2004 Disease Flares
The number of BILAG-2004 disease flares as defined as one new BILAG A or two new BILAG B scores will be assessed. The BILAG-2004\* is a validated index for assessing SLE disease activity. The BILAG-2004 includes 97 clinical and laboratory items to evaluate SLE disease activity in 9 organ systems. \* BILAG-2004: British Isles Lupus Assessment Group 2004.
Time frame: Visit 5 (Day 85)
Population: The safety population includes all participants who received at least one dose of study treatment. Number of participants analyzed is number of participants in the safety population with data at the visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High: JBT-101 20mg/20mg | Number of BILAG-2004 Disease Flares | One new BILAG A Flare | 2 Number of Participants |
| High: JBT-101 20mg/20mg | Number of BILAG-2004 Disease Flares | Two new BILAG B Flares | 0 Number of Participants |
| Medium: JBT-101 20mg/Placebo | Number of BILAG-2004 Disease Flares | Two new BILAG B Flares | 0 Number of Participants |
| Medium: JBT-101 20mg/Placebo | Number of BILAG-2004 Disease Flares | One new BILAG A Flare | 0 Number of Participants |
| Low: JBT-101 5mg/5mg | Number of BILAG-2004 Disease Flares | One new BILAG A Flare | 0 Number of Participants |
| Low: JBT-101 5mg/5mg | Number of BILAG-2004 Disease Flares | Two new BILAG B Flares | 0 Number of Participants |
| Placebo | Number of BILAG-2004 Disease Flares | One new BILAG A Flare | 1 Number of Participants |
| Placebo | Number of BILAG-2004 Disease Flares | Two new BILAG B Flares | 0 Number of Participants |
Secondary
Number of BILAG-2004 Disease Flares
The number of BILAG-2004 disease flares as defined as one new BILAG A or two new BILAG B scores will be assessed. The BILAG-2004\* is a validated index for assessing SLE disease activity. The BILAG-2004 includes 97 clinical and laboratory items to evaluate SLE disease activity in 9 organ systems. \* BILAG-2004: British Isles Lupus Assessment Group 2004.
Time frame: Visit 3 (Day 29)
Population: The safety population includes all participants who received at least one dose of study treatment. Number of participants analyzed is number of participants in the safety population with data at the visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High: JBT-101 20mg/20mg | Number of BILAG-2004 Disease Flares | One new BILAG A Flare | 0 Number of Participants |
| High: JBT-101 20mg/20mg | Number of BILAG-2004 Disease Flares | Two new BILAG B Flares | 0 Number of Participants |
| Medium: JBT-101 20mg/Placebo | Number of BILAG-2004 Disease Flares | Two new BILAG B Flares | 1 Number of Participants |
| Medium: JBT-101 20mg/Placebo | Number of BILAG-2004 Disease Flares | One new BILAG A Flare | 0 Number of Participants |
| Low: JBT-101 5mg/5mg | Number of BILAG-2004 Disease Flares | One new BILAG A Flare | 0 Number of Participants |
| Low: JBT-101 5mg/5mg | Number of BILAG-2004 Disease Flares | Two new BILAG B Flares | 0 Number of Participants |
| Placebo | Number of BILAG-2004 Disease Flares | One new BILAG A Flare | 0 Number of Participants |
| Placebo | Number of BILAG-2004 Disease Flares | Two new BILAG B Flares | 0 Number of Participants |
Secondary
Number of Grade 3 or Higher Treatment-emergent Adverse Events (TEAE) Related to Study Product
Treatment-emergent Adverse Events grading will be defined by the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. The number of TEAE will be identified by monitoring participant-reported AEs, vital signs, medical history, physical exams, blood and urine safety tests, 12-lead electrocardiograms, and the Addiction Research Center Inventory-Marijuana (ARCI-M). TEAE are defined as AEs that, in the opinion of the blinded/masked site investigator, are possibly, probably or definitely related to the assigned study treatment.
Time frame: Day 1 after initiation of study intervention through Day 113
Population: The safety population includes all participants who received at least one dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| High: JBT-101 20mg/20mg | Number of Grade 3 or Higher Treatment-emergent Adverse Events (TEAE) Related to Study Product | 1 Number of Events |
| Medium: JBT-101 20mg/Placebo | Number of Grade 3 or Higher Treatment-emergent Adverse Events (TEAE) Related to Study Product | 0 Number of Events |
| Low: JBT-101 5mg/5mg | Number of Grade 3 or Higher Treatment-emergent Adverse Events (TEAE) Related to Study Product | 0 Number of Events |
| Placebo | Number of Grade 3 or Higher Treatment-emergent Adverse Events (TEAE) Related to Study Product | 0 Number of Events |
Secondary
Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits
The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain.
Time frame: Visit 6 (Day 113)
Population: The modified intent-to-treat population includes all randomized participants who received at least one dose of study drug and had data at Visit 6 (Day 113).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| High: JBT-101 20mg/20mg | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | No Pain | 0 Participants |
| High: JBT-101 20mg/20mg | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Mild Pain | 1 Participants |
| High: JBT-101 20mg/20mg | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Moderate Pain | 8 Participants |
| High: JBT-101 20mg/20mg | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Severe Pain | 2 Participants |
| Medium: JBT-101 20mg/Placebo | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Mild Pain | 2 Participants |
| Medium: JBT-101 20mg/Placebo | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Moderate Pain | 10 Participants |
| Medium: JBT-101 20mg/Placebo | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Severe Pain | 3 Participants |
| Medium: JBT-101 20mg/Placebo | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | No Pain | 1 Participants |
| Low: JBT-101 5mg/5mg | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Moderate Pain | 9 Participants |
| Low: JBT-101 5mg/5mg | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Mild Pain | 5 Participants |
| Low: JBT-101 5mg/5mg | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Severe Pain | 1 Participants |
| Low: JBT-101 5mg/5mg | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | No Pain | 0 Participants |
| Placebo | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Severe Pain | 2 Participants |
| Placebo | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Mild Pain | 0 Participants |
| Placebo | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | No Pain | 0 Participants |
| Placebo | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Moderate Pain | 9 Participants |
Secondary
Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits
The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain.
Time frame: Visit 1 (Baseline)
Population: The modified intent-to-treat population includes all randomized participants who received at least one dose of study drug and had data at Baseline.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| High: JBT-101 20mg/20mg | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | No Pain | 0 Participants |
| High: JBT-101 20mg/20mg | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Mild Pain | 0 Participants |
| High: JBT-101 20mg/20mg | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Moderate Pain | 14 Participants |
| High: JBT-101 20mg/20mg | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Severe Pain | 11 Participants |
| Medium: JBT-101 20mg/Placebo | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Mild Pain | 0 Participants |
| Medium: JBT-101 20mg/Placebo | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Moderate Pain | 18 Participants |
| Medium: JBT-101 20mg/Placebo | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Severe Pain | 9 Participants |
| Medium: JBT-101 20mg/Placebo | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | No Pain | 0 Participants |
| Low: JBT-101 5mg/5mg | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Moderate Pain | 14 Participants |
| Low: JBT-101 5mg/5mg | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Mild Pain | 0 Participants |
| Low: JBT-101 5mg/5mg | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Severe Pain | 10 Participants |
| Low: JBT-101 5mg/5mg | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | No Pain | 0 Participants |
| Placebo | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Severe Pain | 9 Participants |
| Placebo | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Mild Pain | 0 Participants |
| Placebo | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | No Pain | 0 Participants |
| Placebo | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Moderate Pain | 16 Participants |
Secondary
Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits
The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain.
Time frame: Visit 3 (Day 29)
Population: The modified intent-to-treat population includes all randomized participants who received at least one dose of study drug and had data at Visit 3 (Day 29).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| High: JBT-101 20mg/20mg | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | No Pain | 0 Participants |
| High: JBT-101 20mg/20mg | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Mild Pain | 3 Participants |
| High: JBT-101 20mg/20mg | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Moderate Pain | 14 Participants |
| High: JBT-101 20mg/20mg | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Severe Pain | 4 Participants |
| Medium: JBT-101 20mg/Placebo | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Mild Pain | 3 Participants |
| Medium: JBT-101 20mg/Placebo | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Moderate Pain | 16 Participants |
| Medium: JBT-101 20mg/Placebo | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Severe Pain | 5 Participants |
| Medium: JBT-101 20mg/Placebo | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | No Pain | 0 Participants |
| Low: JBT-101 5mg/5mg | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Moderate Pain | 12 Participants |
| Low: JBT-101 5mg/5mg | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Mild Pain | 5 Participants |
| Low: JBT-101 5mg/5mg | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Severe Pain | 6 Participants |
| Low: JBT-101 5mg/5mg | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | No Pain | 0 Participants |
| Placebo | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Severe Pain | 7 Participants |
| Placebo | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Mild Pain | 0 Participants |
| Placebo | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | No Pain | 1 Participants |
| Placebo | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Moderate Pain | 17 Participants |
Secondary
Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits
The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain.
Time frame: Visit 4 (Day 57)
Population: The modified intent-to-treat population includes all randomized participants who received at least one dose of study drug and had data at Visit 4 (Day 57).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| High: JBT-101 20mg/20mg | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | No Pain | 2 Participants |
| High: JBT-101 20mg/20mg | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Mild Pain | 2 Participants |
| High: JBT-101 20mg/20mg | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Moderate Pain | 11 Participants |
| High: JBT-101 20mg/20mg | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Severe Pain | 3 Participants |
| Medium: JBT-101 20mg/Placebo | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Mild Pain | 1 Participants |
| Medium: JBT-101 20mg/Placebo | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Moderate Pain | 16 Participants |
| Medium: JBT-101 20mg/Placebo | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Severe Pain | 4 Participants |
| Medium: JBT-101 20mg/Placebo | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | No Pain | 2 Participants |
| Low: JBT-101 5mg/5mg | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Moderate Pain | 13 Participants |
| Low: JBT-101 5mg/5mg | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Mild Pain | 4 Participants |
| Low: JBT-101 5mg/5mg | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Severe Pain | 5 Participants |
| Low: JBT-101 5mg/5mg | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | No Pain | 0 Participants |
| Placebo | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Severe Pain | 6 Participants |
| Placebo | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Mild Pain | 3 Participants |
| Placebo | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | No Pain | 0 Participants |
| Placebo | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Moderate Pain | 14 Participants |
Secondary
Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits
The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain.
Time frame: Visit 5 (Day 85)
Population: The modified intent-to-treat population includes all randomized participants who received at least one dose of study drug and had data at Visit 5 (Day 85).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| High: JBT-101 20mg/20mg | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | No Pain | 0 Participants |
| High: JBT-101 20mg/20mg | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Mild Pain | 5 Participants |
| High: JBT-101 20mg/20mg | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Moderate Pain | 12 Participants |
| High: JBT-101 20mg/20mg | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Severe Pain | 2 Participants |
| Medium: JBT-101 20mg/Placebo | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Mild Pain | 4 Participants |
| Medium: JBT-101 20mg/Placebo | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Moderate Pain | 12 Participants |
| Medium: JBT-101 20mg/Placebo | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Severe Pain | 4 Participants |
| Medium: JBT-101 20mg/Placebo | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | No Pain | 1 Participants |
| Low: JBT-101 5mg/5mg | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Moderate Pain | 13 Participants |
| Low: JBT-101 5mg/5mg | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Mild Pain | 4 Participants |
| Low: JBT-101 5mg/5mg | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Severe Pain | 4 Participants |
| Low: JBT-101 5mg/5mg | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | No Pain | 1 Participants |
| Placebo | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Severe Pain | 6 Participants |
| Placebo | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Mild Pain | 1 Participants |
| Placebo | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | No Pain | 0 Participants |
| Placebo | Number of Participants With No Pain, Mild Pain, Moderate Pain or Severe Pain in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Moderate Pain | 15 Participants |
Secondary
Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI)
The number of mild/moderate and severe disease flares will be assessed using the SFI instrument to define disease flare(s) and severity. The SELENA SLEDAI Flare Index categorizes disease flares as mild/moderate or severe, based on the highest categories of clinical features recorded or by treatment recommendations by the physician.
Time frame: Visit 6 (Day 113)
Population: The safety population includes all participants who received at least one dose of study treatment. Number of participants analyzed is number of participants in the safety population with data at the visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High: JBT-101 20mg/20mg | Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI) | Severe | 0 participants |
| High: JBT-101 20mg/20mg | Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI) | No Flare | 13 participants |
| High: JBT-101 20mg/20mg | Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI) | Mild/Moderate | 7 participants |
| Medium: JBT-101 20mg/Placebo | Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI) | Severe | 0 participants |
| Medium: JBT-101 20mg/Placebo | Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI) | No Flare | 18 participants |
| Medium: JBT-101 20mg/Placebo | Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI) | Mild/Moderate | 5 participants |
| Low: JBT-101 5mg/5mg | Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI) | Mild/Moderate | 9 participants |
| Low: JBT-101 5mg/5mg | Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI) | Severe | 0 participants |
| Low: JBT-101 5mg/5mg | Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI) | No Flare | 14 participants |
| Placebo | Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI) | Severe | 2 participants |
| Placebo | Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI) | No Flare | 13 participants |
| Placebo | Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI) | Mild/Moderate | 9 participants |
Secondary
Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI)
The number of mild/moderate and severe disease flares will be assessed using the SFI instrument to define disease flare(s) and severity. The SELENA SLEDAI Flare Index categorizes disease flares as mild/moderate or severe, based on the highest categories of clinical features recorded or by treatment recommendations by the physician.
Time frame: Visit 4 (Day 57)
Population: The safety population includes all participants who received at least one dose of study treatment. Number of participants analyzed is number of participants in the safety population with data at the visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High: JBT-101 20mg/20mg | Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI) | Severe | 1 participants |
| High: JBT-101 20mg/20mg | Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI) | No Flare | 17 participants |
| High: JBT-101 20mg/20mg | Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI) | Mild/Moderate | 2 participants |
| Medium: JBT-101 20mg/Placebo | Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI) | Severe | 0 participants |
| Medium: JBT-101 20mg/Placebo | Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI) | No Flare | 20 participants |
| Medium: JBT-101 20mg/Placebo | Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI) | Mild/Moderate | 3 participants |
| Low: JBT-101 5mg/5mg | Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI) | Mild/Moderate | 3 participants |
| Low: JBT-101 5mg/5mg | Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI) | Severe | 0 participants |
| Low: JBT-101 5mg/5mg | Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI) | No Flare | 21 participants |
| Placebo | Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI) | Severe | 0 participants |
| Placebo | Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI) | No Flare | 17 participants |
| Placebo | Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI) | Mild/Moderate | 7 participants |
Secondary
Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI)
The number of mild/moderate and severe disease flares will be assessed using the SFI instrument to define disease flare(s) and severity. The SELENA SLEDAI Flare Index categorizes disease flares as mild/moderate or severe, based on the highest categories of clinical features recorded or by treatment recommendations by the physician.
Time frame: Visit 5 (Day 85)
Population: The safety population includes all participants who received at least one dose of study treatment. Number of participants analyzed is number of participants in the safety population with data at the visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High: JBT-101 20mg/20mg | Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI) | Severe | 0 participants |
| High: JBT-101 20mg/20mg | Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI) | No Flare | 17 participants |
| High: JBT-101 20mg/20mg | Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI) | Mild/Moderate | 3 participants |
| Medium: JBT-101 20mg/Placebo | Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI) | Severe | 1 participants |
| Medium: JBT-101 20mg/Placebo | Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI) | No Flare | 18 participants |
| Medium: JBT-101 20mg/Placebo | Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI) | Mild/Moderate | 4 participants |
| Low: JBT-101 5mg/5mg | Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI) | Mild/Moderate | 2 participants |
| Low: JBT-101 5mg/5mg | Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI) | Severe | 2 participants |
| Low: JBT-101 5mg/5mg | Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI) | No Flare | 19 participants |
| Placebo | Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI) | Severe | 1 participants |
| Placebo | Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI) | No Flare | 19 participants |
| Placebo | Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI) | Mild/Moderate | 4 participants |
Secondary
Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI)
The number of mild/moderate and severe disease flares will be assessed using the SFI instrument to define disease flare(s) and severity. The SELENA SLEDAI Flare Index categorizes disease flares as mild/moderate or severe, based on the highest categories of clinical features recorded or by treatment recommendations by the physician.
Time frame: Visit 3 (Day 29)
Population: The safety population includes all participants who received at least one dose of study treatment. Number of participants analyzed is number of participants in the safety population with data at the visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High: JBT-101 20mg/20mg | Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI) | Severe | 1 Number of Participants |
| High: JBT-101 20mg/20mg | Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI) | No Flare | 16 Number of Participants |
| High: JBT-101 20mg/20mg | Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI) | Mild/Moderate | 4 Number of Participants |
| Medium: JBT-101 20mg/Placebo | Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI) | Severe | 1 Number of Participants |
| Medium: JBT-101 20mg/Placebo | Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI) | No Flare | 22 Number of Participants |
| Medium: JBT-101 20mg/Placebo | Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI) | Mild/Moderate | 2 Number of Participants |
| Low: JBT-101 5mg/5mg | Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI) | Mild/Moderate | 0 Number of Participants |
| Low: JBT-101 5mg/5mg | Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI) | Severe | 1 Number of Participants |
| Low: JBT-101 5mg/5mg | Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI) | No Flare | 23 Number of Participants |
| Placebo | Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI) | Severe | 0 Number of Participants |
| Placebo | Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI) | No Flare | 22 Number of Participants |
| Placebo | Number of SLE Disease Flares by Severity Using the SELENA-SLEDAI Flare Index (SFI) | Mild/Moderate | 3 Number of Participants |
Secondary
Number of Treatment Emergent Events With Elevated Liver Tests
The number of participants with elevated liver tests, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 3 x upper limit of normal and total bilirubin \> 1.5 x the upper limit of normal, present on repeat testing, at Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed.
Time frame: Day 1 through Visit 6 (Day 113)
Population: The safety population includes all participants who received at least one dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| High: JBT-101 20mg/20mg | Number of Treatment Emergent Events With Elevated Liver Tests | 0 Number of Events |
| Medium: JBT-101 20mg/Placebo | Number of Treatment Emergent Events With Elevated Liver Tests | 0 Number of Events |
| Low: JBT-101 5mg/5mg | Number of Treatment Emergent Events With Elevated Liver Tests | 0 Number of Events |
| Placebo | Number of Treatment Emergent Events With Elevated Liver Tests | 0 Number of Events |
Secondary
Number of Treatment Emergent Intolerability Events
The number of intolerability events of the study drug, defined as incidence of discontinuation of study product due to TEAEs at least possibly related to study product from Visits 1 (Day 1) through 5 (Day 85) will be assessed.
Time frame: Day 1 after initiation of study intervention through Visit 5 (Day 85 - Last Day of Treatment)
Population: The safety population includes all participants who received at least one dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| High: JBT-101 20mg/20mg | Number of Treatment Emergent Intolerability Events | 6 Number of Events |
| Medium: JBT-101 20mg/Placebo | Number of Treatment Emergent Intolerability Events | 4 Number of Events |
| Low: JBT-101 5mg/5mg | Number of Treatment Emergent Intolerability Events | 0 Number of Events |
| Placebo | Number of Treatment Emergent Intolerability Events | 0 Number of Events |
Secondary
Number of Treatment Emergent QTc Prolongation Events
The number of treatment emergent QTc prolongation events will be identified when QTc prolongation \> 500 msec total duration and when the change from Visit 1 (Day 1) QTc interval prior to study drug administration \> 60 msec Twelve-lead ECGs were recorded in triplicate at Screening and Visits 1 (Day 1) and 5 (Day 85). The ECGs were evaluated for medically significant abnormalities and QT/QTc intervals. The QT/QTc intervals were measured at Visit 1 (Day 1) before administration and between 2.5 and 3.5 hours after administration of study product in the clinic, at the time of maximum JBT-101 concentration in the blood.
Time frame: Visit 1 (Baseline, Day 1) and Visit 5 (Day 85 - Last Day of Treatment)
Population: The safety population includes all participants who received at least one dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| High: JBT-101 20mg/20mg | Number of Treatment Emergent QTc Prolongation Events | 0 Number of Events |
| Medium: JBT-101 20mg/Placebo | Number of Treatment Emergent QTc Prolongation Events | 0 Number of Events |
| Low: JBT-101 5mg/5mg | Number of Treatment Emergent QTc Prolongation Events | 0 Number of Events |
| Placebo | Number of Treatment Emergent QTc Prolongation Events | 0 Number of Events |
Secondary
Percentage of Participants as Responders Using the SLE Responder Index (SRI)
The SRI is a validated SLE disease activity instrument used to detect clinically meaningful improvement of disease in SLE clinical trials. The SRI is a composite instrument comprised of the SELENA-SLE Disease Activity Index \[SELENA-SLEDAI\], Physician Global Assessment (PGA) and British Isles Lupus Assessment Group (BILAG) 2004. A responder is defined as having at least a 4 point reduction in the SELENA-SLEDAI score, no new BILAG A or no more than 1 new BILAG B domain score, and no increase in the PGA of 0.3 points or more. The percentage of participants who met the criteria for a responder in the SRI at Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed.
Time frame: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85 - Last Day of Treatment) and Visit 6 (Day 113)
Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High: JBT-101 20mg/20mg | Percentage of Participants as Responders Using the SLE Responder Index (SRI) | Day 29 | 19.0 Percentage of Subjects |
| High: JBT-101 20mg/20mg | Percentage of Participants as Responders Using the SLE Responder Index (SRI) | Day 57 | 40.0 Percentage of Subjects |
| High: JBT-101 20mg/20mg | Percentage of Participants as Responders Using the SLE Responder Index (SRI) | Day 85 | 50.0 Percentage of Subjects |
| High: JBT-101 20mg/20mg | Percentage of Participants as Responders Using the SLE Responder Index (SRI) | Day 113 | 21.1 Percentage of Subjects |
| Medium: JBT-101 20mg/Placebo | Percentage of Participants as Responders Using the SLE Responder Index (SRI) | Day 57 | 34.8 Percentage of Subjects |
| Medium: JBT-101 20mg/Placebo | Percentage of Participants as Responders Using the SLE Responder Index (SRI) | Day 85 | 39.1 Percentage of Subjects |
| Medium: JBT-101 20mg/Placebo | Percentage of Participants as Responders Using the SLE Responder Index (SRI) | Day 113 | 34.8 Percentage of Subjects |
| Medium: JBT-101 20mg/Placebo | Percentage of Participants as Responders Using the SLE Responder Index (SRI) | Day 29 | 28.0 Percentage of Subjects |
| Low: JBT-101 5mg/5mg | Percentage of Participants as Responders Using the SLE Responder Index (SRI) | Day 85 | 54.5 Percentage of Subjects |
| Low: JBT-101 5mg/5mg | Percentage of Participants as Responders Using the SLE Responder Index (SRI) | Day 57 | 41.7 Percentage of Subjects |
| Low: JBT-101 5mg/5mg | Percentage of Participants as Responders Using the SLE Responder Index (SRI) | Day 113 | 33.3 Percentage of Subjects |
| Low: JBT-101 5mg/5mg | Percentage of Participants as Responders Using the SLE Responder Index (SRI) | Day 29 | 25.0 Percentage of Subjects |
| Placebo | Percentage of Participants as Responders Using the SLE Responder Index (SRI) | Day 113 | 29.2 Percentage of Subjects |
| Placebo | Percentage of Participants as Responders Using the SLE Responder Index (SRI) | Day 57 | 33.3 Percentage of Subjects |
| Placebo | Percentage of Participants as Responders Using the SLE Responder Index (SRI) | Day 29 | 20.0 Percentage of Subjects |
| Placebo | Percentage of Participants as Responders Using the SLE Responder Index (SRI) | Day 85 | 39.1 Percentage of Subjects |
Comparison: JBT-101 High, JBT-101 Medium, JBT-101 Low, Placebop-value: 0.872Mixed Models Analysis
Comparison: JBT-101 High, JBT-101 Medium, JBT-101 Low, Placebop-value: 0.895Mixed Models Analysis
Comparison: JBT-101 High, JBT-101 Medium, JBT-101 Low, Placebop-value: 0.669Mixed Models Analysis
Comparison: JBT-101 High, JBT-101 Medium, JBT-101 Low, Placebop-value: 0.668Mixed Models Analysis
Secondary
Percentage of Participants Indicating Clinical Benefit in Treatment Satisfaction
At the end of treatment, the participant and their physician will complete separately a survey asking what treatment assignment they believe they received (e.g., JBT-101, placebo, or cannot tell), whether the participant received benefit from their assigned treatment and whether the participant or their physician would choose the treatment received. The percentage of participants who responded that they received clinical benefit from the experimental drug treatment at the end of treatment will be assessed.
Time frame: Visit 5 (Day 85 - Last Day of Treatment)
Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| High: JBT-101 20mg/20mg | Percentage of Participants Indicating Clinical Benefit in Treatment Satisfaction | 59.1 Percentage of Participants |
| Medium: JBT-101 20mg/Placebo | Percentage of Participants Indicating Clinical Benefit in Treatment Satisfaction | 76.0 Percentage of Participants |
| Low: JBT-101 5mg/5mg | Percentage of Participants Indicating Clinical Benefit in Treatment Satisfaction | 69.6 Percentage of Participants |
| Placebo | Percentage of Participants Indicating Clinical Benefit in Treatment Satisfaction | 52.2 Percentage of Participants |
Secondary
Percentage of Participants Who Had 100% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits
The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain. The percent change from baseline in the 7-day average of the maximum NRS-Pain scores prior to study Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed.
Time frame: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85 - Last Day of Treatment) and Visit 6 (Day 113)
Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High: JBT-101 20mg/20mg | Percentage of Participants Who Had 100% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Day 29 | 0 Percentage of Participants |
| High: JBT-101 20mg/20mg | Percentage of Participants Who Had 100% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Day 57 | 0 Percentage of Participants |
| High: JBT-101 20mg/20mg | Percentage of Participants Who Had 100% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Day 85 | 0 Percentage of Participants |
| High: JBT-101 20mg/20mg | Percentage of Participants Who Had 100% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Day 113 | 0 Percentage of Participants |
| Medium: JBT-101 20mg/Placebo | Percentage of Participants Who Had 100% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Day 57 | 4.3 Percentage of Participants |
| Medium: JBT-101 20mg/Placebo | Percentage of Participants Who Had 100% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Day 85 | 4.8 Percentage of Participants |
| Medium: JBT-101 20mg/Placebo | Percentage of Participants Who Had 100% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Day 113 | 0 Percentage of Participants |
| Medium: JBT-101 20mg/Placebo | Percentage of Participants Who Had 100% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Day 29 | 0 Percentage of Participants |
| Low: JBT-101 5mg/5mg | Percentage of Participants Who Had 100% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Day 85 | 4.5 Percentage of Participants |
| Low: JBT-101 5mg/5mg | Percentage of Participants Who Had 100% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Day 57 | 0 Percentage of Participants |
| Low: JBT-101 5mg/5mg | Percentage of Participants Who Had 100% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Day 113 | 0 Percentage of Participants |
| Low: JBT-101 5mg/5mg | Percentage of Participants Who Had 100% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Day 29 | 0 Percentage of Participants |
| Placebo | Percentage of Participants Who Had 100% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Day 113 | 0 Percentage of Participants |
| Placebo | Percentage of Participants Who Had 100% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Day 57 | 0 Percentage of Participants |
| Placebo | Percentage of Participants Who Had 100% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Day 29 | 0 Percentage of Participants |
| Placebo | Percentage of Participants Who Had 100% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Day 85 | 0 Percentage of Participants |
Comparison: JBT-101 High, JBT-101 Medium, JBT-101 Low, Placebop-value: >0.999Exact Likelihood Ratio Test
Comparison: JBT-101 High, JBT-101 Medium, JBT-101 Low, Placebop-value: 0.861Exact Likelihood Ratio Test
Secondary
Percentage of Participants Who Had at Least 30% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits
The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain. The percent change from baseline in the 7-day average of the maximum NRS-Pain scores prior to study Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed.
Time frame: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85 - Last Day of Treatment) and Visit 6 (Day 113)
Population: mITT: The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High: JBT-101 20mg/20mg | Percentage of Participants Who Had at Least 30% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Day 29 | 19.0 Percentage of Participants |
| High: JBT-101 20mg/20mg | Percentage of Participants Who Had at Least 30% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Day 57 | 38.9 Percentage of Participants |
| High: JBT-101 20mg/20mg | Percentage of Participants Who Had at Least 30% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Day 85 | 42.1 Percentage of Participants |
| High: JBT-101 20mg/20mg | Percentage of Participants Who Had at Least 30% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Day 113 | 36.4 Percentage of Participants |
| Medium: JBT-101 20mg/Placebo | Percentage of Participants Who Had at Least 30% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Day 57 | 47.8 Percentage of Participants |
| Medium: JBT-101 20mg/Placebo | Percentage of Participants Who Had at Least 30% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Day 85 | 42.9 Percentage of Participants |
| Medium: JBT-101 20mg/Placebo | Percentage of Participants Who Had at Least 30% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Day 113 | 31.3 Percentage of Participants |
| Medium: JBT-101 20mg/Placebo | Percentage of Participants Who Had at Least 30% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Day 29 | 33.3 Percentage of Participants |
| Low: JBT-101 5mg/5mg | Percentage of Participants Who Had at Least 30% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Day 85 | 40.9 Percentage of Participants |
| Low: JBT-101 5mg/5mg | Percentage of Participants Who Had at Least 30% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Day 57 | 40.9 Percentage of Participants |
| Low: JBT-101 5mg/5mg | Percentage of Participants Who Had at Least 30% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Day 113 | 46.7 Percentage of Participants |
| Low: JBT-101 5mg/5mg | Percentage of Participants Who Had at Least 30% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Day 29 | 30.4 Percentage of Participants |
| Placebo | Percentage of Participants Who Had at Least 30% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Day 113 | 27.3 Percentage of Participants |
| Placebo | Percentage of Participants Who Had at Least 30% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Day 57 | 26.1 Percentage of Participants |
| Placebo | Percentage of Participants Who Had at Least 30% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Day 29 | 20.0 Percentage of Participants |
| Placebo | Percentage of Participants Who Had at Least 30% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Day 85 | 27.3 Percentage of Participants |
Comparison: The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each active treatment vs. placebo at Day 29.p-value: 0.594Mixed Models Analysis
Comparison: The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each active treatment vs. placebo at Day 57.p-value: 0.487Mixed Models Analysis
Comparison: The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each active treatment vs. placebo at Day 85.p-value: 0.76Mixed Models Analysis
Comparison: The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each active treatment vs. placebo at Day 113.p-value: 0.676Mixed Models Analysis
Secondary
Percentage of Participants Who Had at Least 50% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits
The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain. The percent change from baseline in the 7-day average of the maximum NRS-Pain scores prior to study Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed.
Time frame: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85 - Last Day of Treatment) and Visit 6 (Day 113)
Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High: JBT-101 20mg/20mg | Percentage of Participants Who Had at Least 50% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Day 29 | 14.3 Percentage of Participants |
| High: JBT-101 20mg/20mg | Percentage of Participants Who Had at Least 50% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Day 57 | 16.7 Percentage of Participants |
| High: JBT-101 20mg/20mg | Percentage of Participants Who Had at Least 50% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Day 85 | 26.3 Percentage of Participants |
| High: JBT-101 20mg/20mg | Percentage of Participants Who Had at Least 50% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Day 113 | 9.1 Percentage of Participants |
| Medium: JBT-101 20mg/Placebo | Percentage of Participants Who Had at Least 50% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Day 57 | 13.0 Percentage of Participants |
| Medium: JBT-101 20mg/Placebo | Percentage of Participants Who Had at Least 50% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Day 85 | 23.8 Percentage of Participants |
| Medium: JBT-101 20mg/Placebo | Percentage of Participants Who Had at Least 50% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Day 113 | 12.5 Percentage of Participants |
| Medium: JBT-101 20mg/Placebo | Percentage of Participants Who Had at Least 50% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Day 29 | 16.7 Percentage of Participants |
| Low: JBT-101 5mg/5mg | Percentage of Participants Who Had at Least 50% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Day 85 | 22.7 Percentage of Participants |
| Low: JBT-101 5mg/5mg | Percentage of Participants Who Had at Least 50% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Day 57 | 18.2 Percentage of Participants |
| Low: JBT-101 5mg/5mg | Percentage of Participants Who Had at Least 50% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Day 113 | 20.0 Percentage of Participants |
| Low: JBT-101 5mg/5mg | Percentage of Participants Who Had at Least 50% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Day 29 | 17.4 Percentage of Participants |
| Placebo | Percentage of Participants Who Had at Least 50% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Day 113 | 0 Percentage of Participants |
| Placebo | Percentage of Participants Who Had at Least 50% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Day 57 | 13.0 Percentage of Participants |
| Placebo | Percentage of Participants Who Had at Least 50% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Day 29 | 8.0 Percentage of Participants |
| Placebo | Percentage of Participants Who Had at Least 50% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits | Day 85 | 4.5 Percentage of Participants |
p-value: 0.796Exact Likelihood Ratio Test
p-value: 0.955Exact Likelihood Ratio Test
p-value: 0.211Exact Likelihood Ratio Test
p-value: 0.481Exact Likelihood Ratio Test
Secondary
Percentage of Participants Who Had at Least 75% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits Score
The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain. The percent change from baseline in the 7-day average of the maximum NRS-Pain scores prior to study Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed.
Time frame: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85 - Last Day of Treatment) and Visit 6 (Day 113)
Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High: JBT-101 20mg/20mg | Percentage of Participants Who Had at Least 75% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits Score | Day 29 | 0 Percentage of Participants |
| High: JBT-101 20mg/20mg | Percentage of Participants Who Had at Least 75% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits Score | Day 57 | 11.1 Percentage of Participants |
| High: JBT-101 20mg/20mg | Percentage of Participants Who Had at Least 75% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits Score | Day 85 | 5.3 Percentage of Participants |
| High: JBT-101 20mg/20mg | Percentage of Participants Who Had at Least 75% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits Score | Day 113 | 0 Percentage of Participants |
| Medium: JBT-101 20mg/Placebo | Percentage of Participants Who Had at Least 75% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits Score | Day 57 | 8.7 Percentage of Participants |
| Medium: JBT-101 20mg/Placebo | Percentage of Participants Who Had at Least 75% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits Score | Day 85 | 4.8 Percentage of Participants |
| Medium: JBT-101 20mg/Placebo | Percentage of Participants Who Had at Least 75% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits Score | Day 113 | 12.5 Percentage of Participants |
| Medium: JBT-101 20mg/Placebo | Percentage of Participants Who Had at Least 75% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits Score | Day 29 | 4.2 Percentage of Participants |
| Low: JBT-101 5mg/5mg | Percentage of Participants Who Had at Least 75% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits Score | Day 85 | 9.1 Percentage of Participants |
| Low: JBT-101 5mg/5mg | Percentage of Participants Who Had at Least 75% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits Score | Day 57 | 4.5 Percentage of Participants |
| Low: JBT-101 5mg/5mg | Percentage of Participants Who Had at Least 75% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits Score | Day 113 | 0 Percentage of Participants |
| Low: JBT-101 5mg/5mg | Percentage of Participants Who Had at Least 75% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits Score | Day 29 | 8.7 Percentage of Participants |
| Placebo | Percentage of Participants Who Had at Least 75% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits Score | Day 113 | 0 Percentage of Participants |
| Placebo | Percentage of Participants Who Had at Least 75% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits Score | Day 57 | 4.3 Percentage of Participants |
| Placebo | Percentage of Participants Who Had at Least 75% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits Score | Day 29 | 4.0 Percentage of Participants |
| Placebo | Percentage of Participants Who Had at Least 75% Improvement From Baseline in the 7-day Average of the Maximum NRS-Pain Score Prior to Study Visits Score | Day 85 | 0 Percentage of Participants |
p-value: 0.79Exact Likelihood Ratio Test
p-value: 0.843Exact Likelihood Ratio Test
p-value: 0.637Exact Likelihood Ratio Test
p-value: 0.243Exact Likelihood Ratio Test
Secondary
Percentage of Participants With Improvement From Baseline in Arthritis in BILAG-2004
The BILAG-2004\* is a validated index for assessing SLE disease activity. The BILAG-2004 includes 97 clinical and laboratory items to evaluate SLE disease activity in 9 organ systems. The severity of arthritis at baseline will be determine by the highest arthritis severity level where arthritis is indicated as improving, same, new or worse\* BILAG-2004: British Isles Lupus Assessment Group 2004. The percentage of participants who met the criteria for improvement of arthritis in the BILAG-2004 Musculoskeletal assessments (using the mild, moderate and severe arthritis questions on the assessment) at Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed.
Time frame: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85 - Last Day of Treatment) and Visit 6 (Day 113)
Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| High: JBT-101 20mg/20mg | Percentage of Participants With Improvement From Baseline in Arthritis in BILAG-2004 | 50.0 Percentage of Subjects |
| Medium: JBT-101 20mg/Placebo | Percentage of Participants With Improvement From Baseline in Arthritis in BILAG-2004 | 56.5 Percentage of Subjects |
| Low: JBT-101 5mg/5mg | Percentage of Participants With Improvement From Baseline in Arthritis in BILAG-2004 | 78.2 Percentage of Subjects |
| Placebo | Percentage of Participants With Improvement From Baseline in Arthritis in BILAG-2004 | 58.3 Percentage of Subjects |
Secondary
Percentage of Participants With Increased Scores From Baseline on ARCI-M
The percentage of participants who experienced ≥1 score increase on the ARCI-M from the Visit 1 (Day 1) pre-dose assessment at Visit 1 (Day 1) post-dose, Visit 3 (Day 29) and Visit 5 (Day 85) will be assessed. The ARCI-M questionnaire was completed by subjects at Visit1 (Day 1) pre- and post-dosing, Visit 3 (Day 29) and Visit 5 (Day 85). This is a 12-item true/false questionnaire developed by the National Institutes of Drug Abuse, designed to detect the full range of subjective responses experienced by marijuana users. An answer of true has an assigned value of 1 and an answer of false has an assigned value of 0. The ARCI-M score was computed as the sum of the assigned values for all 12 questions and can range from 0 to 12. If a question is missed, the score is not calculated.
Time frame: Visit 1 (Baseline, Day 1-prior to treatment initiation), Visit 1 (Baseline, Day 1-post-treatment initiation) Visit 3 (Day 29) and Visit 5 (Day 85 - Last Day of Treatment)
Population: mITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High: JBT-101 20mg/20mg | Percentage of Participants With Increased Scores From Baseline on ARCI-M | Day 1 Post-Dose | 25.0 Percentage of Participants |
| High: JBT-101 20mg/20mg | Percentage of Participants With Increased Scores From Baseline on ARCI-M | Day 85 | 11.1 Percentage of Participants |
| High: JBT-101 20mg/20mg | Percentage of Participants With Increased Scores From Baseline on ARCI-M | Day 29 | 45.0 Percentage of Participants |
| Medium: JBT-101 20mg/Placebo | Percentage of Participants With Increased Scores From Baseline on ARCI-M | Day 1 Post-Dose | 11.1 Percentage of Participants |
| Medium: JBT-101 20mg/Placebo | Percentage of Participants With Increased Scores From Baseline on ARCI-M | Day 85 | 39.1 Percentage of Participants |
| Medium: JBT-101 20mg/Placebo | Percentage of Participants With Increased Scores From Baseline on ARCI-M | Day 29 | 37.5 Percentage of Participants |
| Low: JBT-101 5mg/5mg | Percentage of Participants With Increased Scores From Baseline on ARCI-M | Day 29 | 29.2 Percentage of Participants |
| Low: JBT-101 5mg/5mg | Percentage of Participants With Increased Scores From Baseline on ARCI-M | Day 1 Post-Dose | 20.8 Percentage of Participants |
| Low: JBT-101 5mg/5mg | Percentage of Participants With Increased Scores From Baseline on ARCI-M | Day 85 | 27.3 Percentage of Participants |
| Placebo | Percentage of Participants With Increased Scores From Baseline on ARCI-M | Day 1 Post-Dose | 4.0 Percentage of Participants |
| Placebo | Percentage of Participants With Increased Scores From Baseline on ARCI-M | Day 85 | 56.5 Percentage of Participants |
| Placebo | Percentage of Participants With Increased Scores From Baseline on ARCI-M | Day 29 | 36.0 Percentage of Participants |
Secondary
Percentage of Participants With Presence of Arthritis in SELENA-SLEDAI
The Safety of Estrogen in Lupus National Assessment (SELENA) Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) is a validated tool for assessing SLE disease activity. The percentage of participants with arthritis indicated as Present on the SELENA SLEDAI at Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed. \[A single question on the SELENA SLEDAI with a response of Present or Absent was assessed.\]
Time frame: Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85 - Last Day of Treatment) and Visit 6 (Day 113)
Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High: JBT-101 20mg/20mg | Percentage of Participants With Presence of Arthritis in SELENA-SLEDAI | Day 29 | 14.3 Percentage of Participants |
| High: JBT-101 20mg/20mg | Percentage of Participants With Presence of Arthritis in SELENA-SLEDAI | Day 57 | 30.0 Percentage of Participants |
| High: JBT-101 20mg/20mg | Percentage of Participants With Presence of Arthritis in SELENA-SLEDAI | Day 85 | 45.0 Percentage of Participants |
| High: JBT-101 20mg/20mg | Percentage of Participants With Presence of Arthritis in SELENA-SLEDAI | Day 113 | 15.0 Percentage of Participants |
| Medium: JBT-101 20mg/Placebo | Percentage of Participants With Presence of Arthritis in SELENA-SLEDAI | Day 57 | 39.1 Percentage of Participants |
| Medium: JBT-101 20mg/Placebo | Percentage of Participants With Presence of Arthritis in SELENA-SLEDAI | Day 85 | 39.1 Percentage of Participants |
| Medium: JBT-101 20mg/Placebo | Percentage of Participants With Presence of Arthritis in SELENA-SLEDAI | Day 113 | 39.1 Percentage of Participants |
| Medium: JBT-101 20mg/Placebo | Percentage of Participants With Presence of Arthritis in SELENA-SLEDAI | Day 29 | 28.0 Percentage of Participants |
| Low: JBT-101 5mg/5mg | Percentage of Participants With Presence of Arthritis in SELENA-SLEDAI | Day 85 | 47.8 Percentage of Participants |
| Low: JBT-101 5mg/5mg | Percentage of Participants With Presence of Arthritis in SELENA-SLEDAI | Day 57 | 45.8 Percentage of Participants |
| Low: JBT-101 5mg/5mg | Percentage of Participants With Presence of Arthritis in SELENA-SLEDAI | Day 113 | 34.8 Percentage of Participants |
| Low: JBT-101 5mg/5mg | Percentage of Participants With Presence of Arthritis in SELENA-SLEDAI | Day 29 | 20.8 Percentage of Participants |
| Placebo | Percentage of Participants With Presence of Arthritis in SELENA-SLEDAI | Day 113 | 25.0 Percentage of Participants |
| Placebo | Percentage of Participants With Presence of Arthritis in SELENA-SLEDAI | Day 57 | 25.0 Percentage of Participants |
| Placebo | Percentage of Participants With Presence of Arthritis in SELENA-SLEDAI | Day 29 | 16.0 Percentage of Participants |
| Placebo | Percentage of Participants With Presence of Arthritis in SELENA-SLEDAI | Day 85 | 33.3 Percentage of Participants |
Comparison: The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each of the 3 active treatments vs. placebo at Day 29.p-value: 0.669Mixed Models Analysis
Comparison: The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each of the 3 active treatments vs. placebo at Day 57.p-value: 0.432Mixed Models Analysis
Comparison: The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each of the 3 active treatments vs. placebo at Day 85.p-value: 0.78Mixed Models Analysis
Comparison: The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each of the 3 active treatments vs. placebo at Day 113.p-value: 0.285Mixed Models Analysis
Secondary
Percentage of Physicians Indicating Participant Clinical Benefit in Treatment Satisfaction
At the end of treatment, the participant and their physician will complete separately a survey asking what treatment assignment they believe they received (e.g., JBT-101, placebo, or cannot tell), whether the participant received benefit from their assigned treatment and whether the participant or their physician would choose the treatment received. The percentage of physicians who responded that the participant received clinical benefit from the experimental drug treatment at the end of treatment will be assessed.
Time frame: Visit 5 (Day 85 - Last Day of Treatment)
Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| High: JBT-101 20mg/20mg | Percentage of Physicians Indicating Participant Clinical Benefit in Treatment Satisfaction | 43.5 Percentage of Physicians |
| Medium: JBT-101 20mg/Placebo | Percentage of Physicians Indicating Participant Clinical Benefit in Treatment Satisfaction | 60.0 Percentage of Physicians |
| Low: JBT-101 5mg/5mg | Percentage of Physicians Indicating Participant Clinical Benefit in Treatment Satisfaction | 65.2 Percentage of Physicians |
| Placebo | Percentage of Physicians Indicating Participant Clinical Benefit in Treatment Satisfaction | 66.7 Percentage of Physicians |