Clinical Trial Search

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

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 at 6 Months — -9 units on a scale — p=< .001

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

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

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

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

Primary: Proportion of Participants Who Attain Inactive Disease by 6 Months — 10; 17 participants

Primary: Number of Participants With a Two-step Reduction in Inflammation — 5 participants

Primary: Change in Dermatomyositis-associated Calcinosis of a Single Lesion by Assessing Its Severity as Measured by a Difference in Physician Calcinosis Visual Analog Scales…

Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) — 29; 5 participants

Primary: Time to Response to Treatment, as Determined by a Modified JIA ACR30 Requiring no Fever, Coupled With a Requirement for Corticosteroid Taper in Participants Who Are…

Primary: Overall Survival — 88.0 percentage of participants

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

Primary: Percent of Patients With a Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30 (ACR30) Flare in Part II of the Study (Weeks 16-40) — 48.1; 25.6…

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

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: Part I: Percentage of Participants With ≥30% Improvement in Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Core Set and Absence of Fever…

Primary: Number of Subjects in the Non-MTX Stratum With Disease Flare During the Double-Blind Phase — 13; 20 Participants — p=0.031

Primary: Number of Subjects Achieving Pediatric American College of Rheumatology 30% (PedACR30) Response at Week 16 — 23 Participants

Primary: Apparent Oral Clearance (CL/F) — 28.09; 25.48; 20.53 liter per hour

Primary: Time to Occurrence of Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis (JRA/JIA) Disease Flare During Double-Blind Phase (Period B) — NA; 6 months — p=0.0002

Primary: Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) — 12; 7; 5; 0 participants

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

Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) — 7; 13; 20 Participants