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Monoclonal Antibodies

Anifrolumab for Lupus(Tulip SC Trial)

Phase 3
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
To be eligible a patient must have SLEDAI-2K ≥ 6 points and "Clinical" SLEDAI-2K score ≥4 points at screening
BILAG2004 with at least 1 of the following: BILAG2004 level A disease in ≥ 1 organ system, BILAG2004 level B disease in ≥ 2 organ systems, Physician's Global Assessment (PGA) score ≥ 1.0 on a 0 to 3 VAS at Screening, Antinuclear antibody, and/or Anti-dsDNA and/oranti-Smith positive at Screening
Must not have
Be younger than 18 years old
Screening 3 weeks
Treatment Varies
Follow Upbaseline through week 60
Awards & highlights
Pivotal Trial

Tulip SC Trial Summary

This trial is testing a new drug for lupus patients who are not responding to current treatments.

Eligible Conditions
  • Lupus

Tulip SC Trial Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Tulip SC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through week 60
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through week 60 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response
Secondary outcome measures
Annualized flare rate
BICLA response
BICLA response with maintained low (or reduced) use of oral corticosteroid (OCS)
+7 more
Other outcome measures
Adverse Event Overview

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Tulip SC Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AnifrolumabExperimental Treatment1 Intervention
Solution for injection in aPFS
Group II: PlaceboPlacebo Group1 Intervention
Solution for injection in aPFS

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,181 Previous Clinical Trials
289,629,948 Total Patients Enrolled
Iqvia Pty LtdIndustry Sponsor
105 Previous Clinical Trials
170,498 Total Patients Enrolled

Media Library

Anifrolumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04877691 — Phase 3
Lupus Research Study Groups: Anifrolumab, Placebo
Lupus Clinical Trial 2023: Anifrolumab Highlights & Side Effects. Trial Name: NCT04877691 — Phase 3
Anifrolumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04877691 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open slots for new patients in this clinical trial?

"The clinicaltrials.gov website reveals that this study is still actively looking for volunteers. The trial was first advertised on June 8th, 2021 and was most recently updated on October 24th, 2022."

Answered by AI

Could you please list which hospitals are conducting this research?

"Presently, this clinical trial is being conducted in 27 locations, which are situated in Upland, Newark, Manhasset, and other cities. If you choose to enroll in this trial, try to select the location closest to you to reduce travel time."

Answered by AI

Has there been previous research on Medi-546?

"Medi-546 was first studied in 2021 at Research Site. It has since been used in 18245 clinical trials. Presently, there are 3 ongoing studies, the majority of which are based in Upland, California."

Answered by AI

How many people are guinea pigs in this experiment?

"That is correct. According to the most recent update on clinicaltrials.gov, this study is still recruiting patients. The trial was first posted on June 8th, 2021 and was last updated on October 24th, 2020. They are looking for 360 participants across 27 sites."

Answered by AI

Does this experiment represent a breakthrough in medical research?

"AstraZeneca first sponsored a study for Medi-546 in 2021. Since then, there has been significant global research interest in the drug. Medi-546 received its Phase 3 drug approval after the first study in 2021, which involved 360 participants. As of now, there are 3 active trials for Medi-546 being conducted in 40 cities across 28 countries."

Answered by AI

When can patients expect Medi-546 to hit the market?

"Medi-546 is in Phase 3 of clinical trials, so there is some data supporting efficacy and multiple rounds of data supporting safety, making it a 3 on our safety scale."

Answered by AI

If I meet the qualifications, may I enroll in this research study?

"The ideal candidate for this study would have lupus erythematosus, systemic and be within the age bracket of 18 to 70. A total of 360 individuals are needed for this clinical trial."

Answered by AI

Would it be possible to enroll in this experiment if I am over the age of seventy?

"The age requirements for this study are that participants must have turned 18 but not yet reached their 70th birthday."

Answered by AI

Who else is applying?

What state do they live in?
How old are they?
18 - 65
What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
~83 spots leftby Sep 2024