ALPN-101 for Lupus

(Synergy Trial)

No longer recruiting at 77 trial locations

Overseen By Rosalie Samalenge

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Alpine Immune Sciences Inc, A Subsidiary of Vertex

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ALPN-101 for people with lupus, specifically those with moderate to severe symptoms. The study aims to assess the safety and effectiveness of this treatment compared to a placebo, which contains no active ingredients. Participants will receive either ALPN-101 or a placebo every two weeks for up to 24 weeks. Eligible individuals must have had lupus for at least six months and currently experience active symptoms. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires that your standard lupus medications be stable before you start. This means you should not change your current medications right before joining the study.

Is there any evidence suggesting that ALPN-101 is likely to be safe for humans?

Research has shown that ALPN-101 (acazicolcept) has been tested in patients to assess its safety and tolerability. Earlier studies examined the body's response to the treatment. Although specific results are not provided here, the progression to the current phase suggests it was safe enough to continue testing.

In previous research, patients taking ALPN-101 were monitored for side effects. While detailed results are not shared, advancing to this phase typically indicates the treatment was well-tolerated in earlier trials. This is a positive sign for its potential safety in further testing for patients with systemic lupus erythematosus (SLE). Patients should always consult their healthcare provider to understand the potential risks and benefits before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for lupus?

Unlike the standard treatments for lupus, which typically involve corticosteroids and immunosuppressants to dampen the immune response, ALPN-101 (Acazicolcept) targets a novel pathway by inhibiting both the CD28 and ICOS co-stimulation pathways. This dual mechanism could potentially offer more precise control over the immune system, reducing symptoms and offering a new avenue for those who do not respond well to existing therapies. Researchers are excited because this approach might not only improve efficacy but also reduce the side effects commonly associated with broader immune suppression.

What evidence suggests that ALPN-101 might be an effective treatment for lupus?

Research has shown that ALPN-101, also known as acazicolcept, may help treat systemic lupus erythematosus (SLE). This treatment blocks two parts of the immune system, CD28 and ICOS, which are involved in the body's defense response. Animal studies demonstrated that this method can lessen disease symptoms. The treatment is being developed to potentially calm the overactive immune system in people with lupus. Although research in humans is ongoing, early results suggest ALPN-101 could be effective for SLE. Participants in this trial will receive either ALPN-101 or a placebo to further evaluate its effectiveness and safety. ^{1 2 3 5 6}

Who Is on the Research Team?

Rachel Peterson, MD

Principal Investigator

Alpine Immune Sciences, Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Participants received a weight-based dose of 3 milligrams/kilogram (mg/kg) ALPN-101 once every 2 weeks (Q2W) up to 24 weeks.

Group II: Placebo Placebo Group 1 Intervention

Participants received placebo matched to ALPN-101 up to 24 weeks.

Who Is Running the Clinical Trial?

Alpine Immune Sciences Inc, A Subsidiary of Vertex

Lead Sponsor

Trials

1

Recruited

480+

Alpine Immune Sciences, Inc.

Lead Sponsor

Trials

9

Recruited

770+

Citations

1. trials.arthritis.org trials.arthritis.org/trials/NCT04835441

ALPN-101 (Acazicolcept) in Systemic Lupus Erythematosus Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8728910/

Acazicolcept (ALPN-101), a dual ICOS/CD28 antagonist ... We herein investigated the efficacy of acazicolcept (ALPN-101), a dual ICOS/CD28 antagonist, in two complementary SSc-related mouse models.

3. ctv.veeva.com ctv.veeva.com/study/alpn-101-acazicolcept-in-systemic-lupus-erythematosus

ALPN-101 (Acazicolcept) in Systemic Lupus Erythematosus This is Phase 2, multinational, randomized, blinded study to evaluate the safety, tolerability, efficacy, immunogenicity, pharmacokinetics and pharmacodynamics ...

4. firstwordpharma.com firstwordpharma.com/story/5800786

Alpine Immune Sciences Presents New Translational Data ... Acazicolcept (ALPN-101) is a first-in-class, dual inhibitor of the CD28 and ICOS T-cell costimulatory pathways being developed for treatment of systemic lupus ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04835441

ALPN-101 (Acazicolcept) in Systemic Lupus Erythematosus The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

6. delta.larvol.com delta.larvol.com/Products/?ProductId=6e5c2e8a-6436-46e5-9a3a-75cc25a09671

acazicolcept (ALPN-101) / Alpine Immune Sci, AbbVie ALPN-101 (Acazicolcept) in Systemic Lupus Erythematosus (clinicaltrials.gov) - P2 | N=76 | Completed | Sponsor: Alpine Immune Sciences, Inc. | Active, not ...