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Monoclonal Antibodies
KZR-616 for Lupus Nephritis (MISSION Trial)
Phase 1 & 2
Waitlist Available
Research Sponsored by Kezar Life Sciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 37 weeks
Awards & highlights
MISSION Trial Summary
This trial will test a new drug, KZR-616, given as a shot under the skin, either once a week for 13 weeks or once a week for 24 weeks.
Eligible Conditions
- Lupus Nephritis
- Lupus
MISSION Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 37 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~37 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1b: Number of Patients Who Experienced at Least One Treatment-Related Treatment-Emergent Adverse Event
Phase 2: Number of Patients With Lupus Nephritis With a 50% Reduction in UPCR
Secondary outcome measures
Phase 1b: PK of KZR-616 (AUC)
Phase 1b: PK of KZR-616 (Cmax)
Phase 1b: PK of KZR-616 (Tmax)
+3 moreSide effects data
From 2022 Phase 2 trial • 25 Patients • NCT0403392646%
Injection site pain
38%
Fatigue
38%
Injection site erythema
31%
Pain
23%
Nausea
23%
Headache
23%
Rash
15%
Myalgia
15%
Injection site nodule
15%
Pyrexia
15%
Chills
15%
Urinary tract infection
15%
Sinus tachycardia
15%
Injection site pruritus
15%
Diarrhoea
15%
Injection site reaction
15%
Dyspnoea
15%
Pruritus generalised
15%
Arthralgia
15%
Muscular weakness
15%
Pruritus
8%
Injection site rash
8%
Injection site swelling
8%
Procedural pain
8%
Dermatitis contact
8%
Mechanic's hand
8%
Proteinuria
8%
Feeling hot
8%
Joint swelling
8%
Coccydynia
8%
Hypertension
8%
Fall
8%
Syncope
8%
QRS axis abnormal
8%
Palpitations
8%
Injection site induration
8%
Influenza like illness
8%
Muscle spasms
8%
Vomiting
8%
Injection site bruising
8%
Feeling cold
8%
Injection site mass
8%
Electrocardiogram QT prolonged
8%
Erythema migrans
8%
Rash generalised
8%
Eye infection
8%
Biopsy
8%
Pharyngitis streptococcal
8%
Panniculitis
8%
Iron deficiency
8%
Urticaria
8%
Dizziness
8%
Muscle twitching
8%
Pain in extremity
8%
Skin discolouration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Period 1 (Zetomipzomib)
Arm A: Period 2 (Placebo)
Arm B: Period 1 (Placebo)
Arm B: Period 2 (Zetomipzomib)
MISSION Trial Design
4Treatment groups
Experimental Treatment
Group I: KZR-616 75 mg + standard of care therapy (Phase 1b)Experimental Treatment1 Intervention
Dose escalation cohort of patients with SLE with and without nephritis to receive 75 mg dose level of KZR-616 in combination with standard of care therapy.
One Phase 1b cohort received 75 mg at some point during the study.
Cohort 3 followed a step-up dosing procedure. Patients in Cohort 3 received zetomipzomib lyophile, 30 mg weekly for 1 week, followed by 75 mg weekly for 12 weeks.
KZR-616 was administered as a SC injection.
Group II: KZR-616 60 mg + standard therapy (Phase 2)Experimental Treatment1 Intervention
60 mg dose level of KZR-616 selected based on data from the phase 1b dose escalation and administered to patients with active lupus nephritis in combination with standard therapy including at least one immunosuppressive agent.
KZR-616 was administered as a SC injection weekly at a dose of 60 mg for 24 weeks (including a step-up from an initial Week 1 dose of 30 mg).
** See Limitations/Caveats for additional information
Group III: KZR-616 60 mg + standard of care therapy (Phase 1b)Experimental Treatment1 Intervention
Dose escalation cohort of patients with SLE with and without nephritis to receive 60 mg dose level of KZR-616 in combination with standard of care therapy.
Four Phase 1b cohorts received 60 mg at some point during the study.
Cohort 2 received 60 mg zetomipzomib frozen maleate weekly for 13 weeks.
Cohorts 2a, 2b, and 2c all followed a step-up dosing procedure. Patients in Cohort 2a received zetomipzomib frozen maleate, 30 mg weekly for 2 weeks, followed by 45 mg weekly for 2 weeks then followed by 60 mg weekly for 9 weeks. Patients in Cohort 2b received zetomipzomib lyophile, 30 mg weekly for 1 week, followed by 60 mg weekly for 12 weeks. Patients in Cohort 2c (tolerability strategies cohort) received zetomipzomib lyophile, 30 mg weekly for 1 week, followed by 60 mg weekly for 12 weeks.
KZR-616 was administered as a SC injection.
Group IV: KZR-616 45 mg + standard of care therapy (Phase 1b)Experimental Treatment1 Intervention
Dose escalation cohort of patients with SLE with and without nephritis to receive 45 mg dose level of KZR-616 in combination with standard of care therapy.
Two Phase 1b cohorts received 45 mg at some point during the study.
Cohort 1 received 45 mg zetomipzomib frozen maleate weekly for 13 weeks.
Cohort 2a followed a step-up dosing procedure. Patients received zetomipzomib frozen maleate, 30 mg weekly for 2 weeks, followed by 45 mg weekly for 2 weeks then followed by 60 mg weekly for 9 weeks.
KZR-616 was administered as a SC injection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
KZR-616
2018
Completed Phase 2
~120
Find a Location
Who is running the clinical trial?
Kezar Life Sciences, Inc.Lead Sponsor
6 Previous Clinical Trials
571 Total Patients Enrolled
1 Trials studying Lupus Nephritis
279 Patients Enrolled for Lupus Nephritis
KezarStudy DirectorKezar Life Sciences, Inc.
2 Previous Clinical Trials
25 Total Patients Enrolled
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