NCT05203419

Multiple Ascending Dose Study of MHS552 in Adults Participants With Systemic Lupus Erythematosus (SLE)

A Two-part, Randomized, Investigator- and Participant- Blinded, Placebo-controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MHS552 in Adult Participants With Systemic Lupus Erythematosus (SLE)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This was a Phase 1b, randomized, placebo-controlled, participant- and investigator- blinded, two-part non-confirmatory multiple ascending dose (MAD) study in adult patients aged 18-65 (inclusive) with active SLE disease (mild-moderate).This MAD study was planned to be conducted in two parts, Part A and Part B sequentially, but the study was terminated before Part B was initiated. In Part A, after a screening period of up to 6 weeks, participants were randomized (in a 3:1 ratio) to MHS552 or placebo administered subcutaneously (s.c.) weekly for four weeks of treatment. Part A was planned to consist of up to 3 cohorts (low, medium, high dose). Due to termination of the trial, Part A consisted of 2 cohorts (low and medium doses). Participants were followed-up during 8 weeks post last dose. The total duration of study participation of Part A was approximately 120 Days. In Part B (not started due to termination of the trial), it was planned that after a screening period of up to 28 days, approximately 12 participants to be randomized (in a 2:1 ratio) to MHS552 or placebo administered s.c. weekly for 12 weeks of treatment (dose to be confirmed).

Conditions

• Lupus Erythematosus, Systemic

Interventions

Type	Name	Description
DRUG	MHS552	MHS552 will be administered once weekly as subcutaneous injection for 4 weeks (Part A) or 12 weeks (Part B)
DRUG	Placebo	Placebo will be administered once weekly as subcutaneous injection for 4 weeks (Part A) or 12 weeks (Part B)

Timeline

• Start date: 2022-03-15
• Primary completion: 2023-06-04
• Completion: 2023-06-04
• First posted: 2022-01-24
• Last updated: 2024-10-09

Locations

1 site across 1 country: Germany