ALPN-101 for Lupus

(Synergy Trial)

Recruiting at 70 trial locations

Overseen By Rosalie Samalenge

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Alpine Immune Sciences, Inc.

Must be taking: Standard lupus medications

Disqualifiers: Nephrotic syndrome, Neuropsychiatric disease, Fibromyalgia, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 28 weeks

76 Participants Needed

Trial Summary

What is the purpose of this trial?

This is Phase 2, multinational, randomized, blinded study to evaluate the safety, tolerability, efficacy, immunogenicity, pharmacokinetics and pharmacodynamics of ALPN-101 (acazicolcept) in adults with moderate to severe active systemic lupus erythematosus (SLE)

Research Team

Rachel Peterson, MD

Principal Investigator

Alpine Immune Sciences, Inc.

Eligibility Criteria

Adults aged 18-65 with moderate to severe active systemic lupus erythematosus (SLE) can join this trial. They must have had SLE for at least 6 months, show certain antibodies in their blood tests, and have stable lupus medications before screening. Active disease is required as shown by specific scores on the SLEDAI test. Participants or their partners capable of pregnancy must use effective birth control.

Inclusion Criteria

My lupus is active with a SLEDAI score of 6 or more and a clinical score of 4 or more.

I was diagnosed with lupus more than 6 months ago.

People who can potentially become pregnant must use very effective contraception if they want to avoid pregnancy.

Exclusion Criteria

I do not have a current serious infection or a history of serious infections.

I have been diagnosed with fibromyalgia.

You have a condition called drug-induced lupus.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ALPN-101 (acazicolcept) or placebo in a randomized, double-blind manner

28 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• ALPN-101

Trial Overview The study is testing ALPN-101 (acazicolcept), a potential new treatment for SLE against a placebo. It's a Phase 2 trial that aims to assess how safe and effective ALPN-101 is, how it affects the immune system, its side effects, and how the body processes it.

Participant Groups

Group I: ALPN-101 (acazicolcept) Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Alpine Immune Sciences, Inc.

Lead Sponsor

Trials

9

Recruited

770+