Subcutaneous Anifrolumab for Lupus

(Tulip SC Trial)

Recruiting in Palo Alto (17 mi)

+135 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AstraZeneca

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing an injectable medication called anifrolumab in adults with moderate-to-severe lupus who haven't fully responded to standard treatments. Anifrolumab works by reducing the immune system's attack on the body to help lessen lupus symptoms. It has been approved for the treatment of moderate to severe systemic lupus erythematosus (SLE) based on evidence from various studies.

Eligibility Criteria

Adults with moderate-to-severe Systemic Lupus Erythematosus (SLE) who've had it for at least 24 weeks and are on stable SLE medications can join. They need a certain level of disease activity and positive tests for specific lupus antibodies. People with severe, unstable SLE, recent serious infections or hospitalizations, immune deficiencies including HIV, hepatitis B or C, certain cancers, or those treated with high-dose steroids recently cannot participate.

Inclusion Criteria

My lupus is severely affecting at least one organ.

My lupus affects at least two organ systems moderately.

I have severe lupus affecting at least one organ.

Exclusion Criteria

I have severe kidney problems due to lupus.

I have not been hospitalized for an infection needing IV treatment in the last 3 years.

I've been hospitalized 3+ times for the same infection in the last year.

Participant Groups

The trial is testing Anifrolumab given under the skin to see if it's effective and safe in adults with SLE who aren't getting better with standard treatments. Participants will either receive Anifrolumab or a placebo without knowing which one they're getting to compare results fairly.

Group I: Anifrolumab Experimental Treatment 1 Intervention

Solution for injection in aPFS

Group II: Placebo Placebo Group 1 Intervention

Solution for injection in aPFS

Anifrolumab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Saphnelo for:

• Moderate to severe systemic lupus erythematosus (SLE)

🇪🇺 Approved in European Union as Saphnelo for:

• Moderate to severe systemic lupus erythematosus (SLE)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Research Site El Paso, TX

Research Site Fullerton, CA

Research Site Lansing, MI

Research Site Tampa, FL

More Trial Locations

Who Is Running the Clinical Trial?

AstraZeneca Lead Sponsor

Iqvia Pty Ltd Industry Sponsor

References