Clinical Trial Search

Primary: Compare the Average Total Improvement Scores at Visits 2 Through 7 During the 6-month Treatment Period Between the Treatment and Placebo Arms — 26.4; 29.3 score on a…

Primary: Change From Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Activity Score at Week 12 (Stage 1, Stage 2 and Amended Stage 2) — -3.44…

Primary: Overall Survival — 88.0 percentage of participants

Primary: Specific Aim 1: Number of Subjects Meeting IMACS Preliminary Definition of Improvement (DOI). — 7 Participants

Primary: Count of Adverse Events Reported — 109; 52 adverse events reported

Primary: Comparison Between the Time to Improvement Between the Two Groups of IIM (Idiopathic Inflammatory Myopathy) Patients — 20.2; 20.0 Weeks — p==0.74

Primary: Mean Change in the Total Improvement Score (TIS) From Start to End of Zetomipzomib (KZR-616) Treatment Period — 25.5; 25.0; 33.1; 33.5 score on a scale

Primary: Measure the Number of Patients Who Had an Increase of ≥20 Points on the Total Improvement Score (TIS) — 21; 37 Participants

Primary: The Primary Endpoint Analysis Would be Overall Response Rate Measured by the Number of Participants Experiencing at Least 4 Points Decrease in CDASI Activity Score at 3…

Primary: Response Rate During Randomized Phase — 3; 1; 5; 2 Participants — p=0.60

Primary: % Predicted Forced Vital Capacity (FVC) Absolute Change — -1.70; -2.05 % predicted FVC — p=<0.05

Primary: The Primary Endpoint is the Total Dose of Glucocorticoids Administered Between Baseline and the End of Treatment. — 124; 135 mg/kg

Primary: Number of Participants Achieving International Myositis Assessment and Clinical Studies Definition of Improvement (IMACS DOI) at Week 24 Without Rescue — 42; 31…

Primary: Occurrence of at Least One Adverse Event — 1; 1; 5; 1 participants

Primary: The Primary Outcome Variable for This Study Will be the Short Form of the Continuous Scale Physical Functional Performance Test (CS-PFP) Called the PFP-10 — 19.0; 20.9…

Primary: To Assess the Safety and Tolerability of IMO-8400 in Adult Subjects With DM — 6; 4; 2; 4 participants

Primary: Mean Total Improvement Score (TIS) at OLE Week 48 — 36.4 score on a scale

Primary: Responder Status Defined as 20% Improvement in at Least 3 Core Set Variables With no More Than 1 of the Remaining Variables, (Muscle Strength Excluded), Worsened by >…

Primary: Proportion of Patients in Disease Remission at Six Months From Trial Entry — 9; 0 Participants

Primary: Change From Baseline in Cutaneous Dermatomyositis at 6 Months — -9 units on a scale — p=< .001

Primary: Number of Patients Meeting the Definition of Improvement (DOI) at Week 24: at Least 3 of 6 Core Set Measures (CSM) Improved by ≥ 20% With no More Than 2 CSM Worsening by…

Primary: Number of Participants With Adverse Events as a Measure of Safety and Tolerability — 0; 2; 10 Participants

Primary: Change in Calcinosis Activity Visual Analogue Scale Score — -3.45 Units on a scale

Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) — 101; 27 participants

Primary: Myasthenia Gravis-Activities of Daily Living (MG-ADL) Summary by Time Point and Myasthenia Gravis Type: Wilcoxon-Mann-Whitney Rank Sum Test Results — 4.96; 3.86; 6.14…

Primary: Percent Predicted Forced Vital Capacity (FVC-%) — 2.24; 2.09 percent predicted — p=0.9326

Primary: Forced Vital Capacity (FVC), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value — 66.52; 66.52; 66.22; 67.03 FVC %-pred — p=0.24

Primary: Number of Patients With Treatment Emergent Adverse Events (TEAES) and Treatment Emergent Serious Adverse Events (SAEs) — 10; 10; 8; 3 Participants

Primary: Incidence of Dose Limiting or Intolerability Treatment Related Adverse Events — 45; 21; 40; 0 events

Primary: Percent Change in the Amplitude of Evoked Compound Muscle Action Potential by Electromyography Between the First to Fifth Response — 0 percent change