Multiple Ascending Dose Study of MHS552 in Adults Participants With Systemic Lupus Erythematosus (SLE)
NCT05203419 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8
Last updated 2024-10-09
Summary
The purpose of this two-part multiple ascending dose study is to evaluate the safety and tolerability of multiple doses of MHS552 in adults with mild to moderately active Systemic Lupus Erythematosus (SLE). Participants will be treated for 4 or 12 weeks followed by an 8-week follow-up period.
Conditions
- Lupus Erythematosus, Systemic
Interventions
- DRUG
-
MHS552
MHS552 will be administered once weekly as subcutaneous injection for 4 weeks (Part A) or 12 weeks (Part B)
- DRUG
-
Placebo will be administered once weekly as subcutaneous injection for 4 weeks (Part A) or 12 weeks (Part B)
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Novartis Pharmaceuticals · Novartis Pharmaceuticals
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-03-15
- Primary Completion
- 2023-06-04
- Completion
- 2023-06-04
Countries
- Germany
Study Locations
More Related Trials
-
An Ascending Dose Study of PIT565 in Participants With Systemic Lupus Erythematosus (SLE).
NCT06335979 ·Status: RECRUITING ·Phase: PHASE1
-
Safety and Efficacy Study of CC312 for Moderate to Severe SLE
NCT07177911 ·Status: RECRUITING ·Phase: PHASE1
-
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of E6742 in Systemic Lupus Erythematosus Participants
NCT05278663 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
An Investigation of Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus Erythematosus (SLE)
NCT01689025 ·Status: TERMINATED ·Phase: PHASE1
-
An Open-label, Study to Assess Safety, Efficacy and Cellular Kinetics of YTB323 in Severe, Refractory Systemic Lupus Erythematosus
NCT05798117 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
A Safety and Tolerability Study of MEDI-570 in Systemic Lupus Erythematosus
NCT01127321 ·Status: TERMINATED ·Phase: PHASE1
-
A Study of a Single Ascending Dose Study of DS-7011a in Healthy Subjects
NCT05203692 ·Status: COMPLETED ·Phase: PHASE1
-
An Open Label Study to Evaluate Daratumumab in Participants With Moderate to Severe Systemic Lupus Erythematosus
NCT04810754 ·Status: UNKNOWN ·Phase: PHASE2
-
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered Mosunetuzumab to Participants With Systemic Lupus Erythematosus
NCT05155345 ·Status: COMPLETED ·Phase: PHASE1
-
An Adaptive Phase II Study to Evaluate the Efficacy, Pharmacodynamics, Safety and Tolerability of GSK2586184
NCT01777256 ·Status: TERMINATED ·Phase: PHASE2
-
Safety Study of AMG 557 in Subjects With Lupus Arthritis
NCT01683695 ·Status: COMPLETED ·Phase: PHASE1
-
Study of M5049 in CLE and SLE Participants
NCT04647708 ·Status: COMPLETED ·Phase: PHASE1
-
Dose Escalation Study of RSLV-132 in Subjects With Systemic Lupus Erythematosus
NCT02194400 ·Status: COMPLETED ·Phase: PHASE1
-
Can Targeted Elimination of B-cell Depletion Therapy and/or Combination Therapy on Systemic Lupus Erythematosus
NCT00556192 ·Status: COMPLETED ·Phase: PHASE2
-
A Study in Participants With Active Systemic Lupus Erythematosus With Inadequate Response to Glucocorticoids and ≥2 Immunosuppressants
NCT07175285 ·Status: RECRUITING
-
Efficacy and Safety of HN2301 in Autoimmune Diseases(AIDs)
NCT06801119 ·Status: RECRUITING ·Phase: PHASE1
-
A Study of AMG 557 in Adults With Systemic Lupus Erythematosus
NCT00774943 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Injections of SHR-2173 in Patients With Systemic Lupus Erythematosus
NCT06955598 ·Status: COMPLETED ·Phase: PHASE1
-
Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus (SLE)
NCT01261793 ·Status: COMPLETED ·Phase: PHASE3
-
Pharmacokinetics Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)
NCT00113971 ·Status: TERMINATED ·Phase: PHASE2
-
A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD5492 in Adult Participants With Systemic Lupus Erythematosus or Idiopathic Inflammatory Myopathies or Rheumatoid Arthritis.
NCT06916806 ·Status: RECRUITING ·Phase: PHASE1
-
A Study of the Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus
NCT02908100 ·Status: COMPLETED ·Phase: PHASE2
-
Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of Care
NCT03371251 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Pharmacodynamics, and Efficacy of P-CD19CD20-ALLO1 in Participants With Severe, Treatment-refractory Systemic Lupus Erythematosus (SLE)
NCT06984341 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1
-
A First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7507062 in Participants With Systemic Lupus Erythematosus
NCT05835986 ·Status: RECRUITING ·Phase: PHASE1