A Study of KZR-616 in Patients With SLE With and Without Lupus Nephritis

• Register: ClinicalTrials.gov
• Last refreshed on: 18 March 2024
• Main ID: NCT03393013
• Date of registration: 21/12/2017
• Prospective Registration: Yes
• Primary sponsor: Kezar Life Sciences, Inc.
• Public title: A Study of KZR-616 in Patients With SLE With and Without Lupus Nephritis MISSION
• Scientific title: A Phase 1b/2 Study of KZR-616 in Patients With Systemic Lupus Erythematosus With and Without Nephritis (MISSION)
• Date of first enrolment: February 20, 2018
• Target sample size: 69
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03393013
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

Australia, Colombia, Mexico, Peru, Poland, Russian Federation, Ukraine, United States

Contacts

• Name: Kezar
• Affiliation: Kezar Life Sciences, Inc.

Key inclusion & exclusion criteria

Key Inclusion Criteria:

Phase 1b:

- Fulfilled the 2012 Systemic Lupus International Collaborating Clinics (SLICC)
classification for SLE

- Had a positive antinuclear antibody (ANA) titer, anti-double stranded DNA (dsDNA)
antibody titer, or a positive anti-Smith antibody titer

- Had active SLE (as indicated by Systemic Lupus Erythematosus Disease Activity Index
2000 [SLEDAI-2K] score =4), and

- Had received at least 1 prior therapy for SLE

Phase 2:

- Had active proliferative LN (Class III or IV, with or without Class V disease)

- Had a UPCR =1.0 measured in 24-hour urine collection

- Had a histologic diagnosis of LN on renal biopsy within the prior 2 years; for
biopsies > 1 year before the Screening visit, one of the following must also be
present at screening: low C3, low C4, or anti-ds-DNA elevated to above normal range

- Fulfilled the 2012 SLICC classification for SLE

- Had a positive ANA titer, anti-dsDNA antibody titer, or anti-Smith antibody titer, and

- Were currently receiving =1 immunosuppressive agent at a stable dose and route of
administration for =8 weeks. If the patient is also on corticosteroids then must be on
a stable dose for = 2 weeks prior to Baseline

Key Exclusion Criteria:

Phase 1b:

- Current or medical history of:

- Central nervous system manifestations by autoimmune disease

- Overlapping autoimmune condition that may affect study assessments/outcomes

- Antiphospholipid syndrome with history of thromboembolic event of within the 52
weeks prior to Screening

- Malignancy of any type, with exceptions for in situ cancer that has been
completely excised and certain cancers >5 years ago

- Positive test at Screening for HIV, hepatitis B/C

- Major surgery within 4 weeks before signing informed consent form or planned major
surgery during the study period

Phase 2:

- Current or medical history of:

- Central nervous system manifestations of SLE

- Overlapping autoimmune condition that may affect study assessments/outcomes

- Antiphospholipid syndrome with history of thromboembolic event of within the 52
weeks prior to Screening

- Malignancy of any type within the last 5 years, with exceptions for appropriately
excised and cured cervical carcinoma in situ or excised basal or squamous cell
carcinomas of the skin

- Has received dialysis within the 52 weeks prior to Screening

- Positive test at Screening for HIV, hepatitis B/C

- Major surgery within 12 weeks before signing informed consent form or planned major
surgery during the study period

- Use of investigational therapy or device, and/or participation in an investigational
trial <8 weeks or 5 half-lives, whichever is longer, prior to Baseline; Patients who
participated in Phase 1b of KZR-616-002 are excluded from Phase 2



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Lupus Nephritis

Intervention(s)

Drug: KZR-616

Primary Outcome(s)

Phase 2: Number of Patients With Lupus Nephritis With a 50% Reduction in UPCR [Time Frame: 24 weeks]

Phase 1b: Number of Patients Who Experienced at Least One Treatment-Related Treatment-Emergent Adverse Event [Time Frame: 25 weeks]

Secondary Outcome(s)

Phase 1b: PK of KZR-616 (Cmax) [Time Frame: 8 hours]

Phase 1b: PK of KZR-616 (AUC) [Time Frame: 8 hours]

Phase 1b: Recommended Phase 2 Doses of Zetomipzomib When Administered as a Subcutaneous Injection [Time Frame: 25 weeks]

Phase 1b: PK of KZR-616 (Tmax) [Time Frame: 8 hours]

Phase 2: Number of Patients With a Partial Renal Response [Time Frame: 24 weeks]

Phase 2: Safety and Tolerability of KZR-616 When Administered as a SC Injection Weekly for 24 Weeks [Time Frame: 37 weeks]

Secondary ID(s)

KZR-616-002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 08/03/2024
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03393013