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About
This was a Phase 2 randomized, double-blind, placebo-controlled, crossover, multicenter study to evaluate the safety, tolerability, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of treatment with KZR-616 in patients with active polymyositis (PM) or dermatomyositis (DM). Patients were evaluated for eligibility during the Screening Period. Eligible patients were stratified by diagnosis of DM or PM and randomized 1:1 to Arm A or Arm B of the study.
During the 32-week treatment period, patients received study drug subcutaneously (SC) once weekly with 2 treatment periods of 16 weeks each.
This study was conducted on an outpatient basis.
Enrollment
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Volunteers
Inclusion criteria
Adult patients at least 18 years of age
Body Mass Index (BMI) of 18 to 40 kg/m^2
Diagnosis of probable or definite DM or PM by the 2017 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) Classification Criteria
Must have their data reviewed by an adjudication committee to confirm eligibility unless at least 1 of the following is present:
Must have demonstrable muscle weakness as measured by the Manual Muscle Testing-8 muscle Groups (MMT-8) with a score ≥80/150 but ≤136/150 units and any 2 of the following:
Documented inadequate response OR have demonstrated documented toxicity or intolerance to prior standard of care therapies
Has had age-appropriate cancer screening that is up to date and negative for evidence of malignancy as per local standard of care
Exclusion criteria
Has significant muscle damage or has a muscle damage VAS score ≥5 cm on the MDI
Any other form of myositis or myopathy other than PM or DM
Any condition that precludes the ability to quantitate muscle strength
Has severe interstitial lung disease or has a pulmonary damage VAS score ≥5 cm on the Myositis Damage Index (MDI)
Presence of autoinflammatory disease
Use of nonpermitted medications or treatments within the specified washout periods prior to screening
Patient has had recent serious or ongoing infection, or risk for serious infection
Any of the following laboratory values at Screening:
Presence of New York Heart Association Class III or IV heart failure, or uncontrolled blood pressure, or prolonged QT interval
Major surgery within 12 weeks before Screening or planned during the study period
Clinical evidence of significant unstable or uncontrolled diseases
Any active or suspected malignancy, including myeloproliferative or lymphoproliferative disorder, or history of documented malignancy within the last 5 years before Screening or within 3 years of diagnosis of myositis, except appropriately excised and cured cervical carcinoma in situ or basal or squamous cell carcinoma of the skin
Primary purpose
Allocation
Interventional model
Masking
25 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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