RECRUITING

A Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study aims to evaluate the efficacy and safety of subcutaneous (SC) anifrolumab versus placebo in adult participants with chronic and/or subacute cutaneous lupus erythematosus (CLE).

Official Title

A Multicenter, Randomized, Double Blind, Placebo Controlled, Phase III Study to Evaluate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus Who Are Refractory and/or Intolerant to Antimalarial Therapy.

Quick Facts

Study Start:2024-06-29
Study Completion:2027-08-22
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06015737

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants must have a confirmed diagnosis of CLE. Diagnosis must be clinically and histologically confirmed with the following:
  2. * CLASI-A total score ≥ 10 points at Screening and confirmed at randomization.
  3. * Inadequate response or intolerant to antimalarial therapy.
  4. * Participants should have no medical history or signs or symptoms of active or prior tuberculosis infection (TB) and the same should reflect in chest radiograph or a chest CT scan result.
  5. * Contraceptive use by males and females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  1. * History or evidence of suicidal ideation.
  2. * Severe or life-threatening Systemic lupus erythematosus (SLE).
  3. * Active SLE or Sjögren's Syndrome.
  4. * Any active skin conditions other than CLE that may interfere with the study.
  5. * History of, or current diagnosis of, catastrophic antiphospholipid syndrome (APS).
  6. * History of recurrent infection requiring hospitalization and IV antibiotics.
  7. * COVID-19 infection.
  8. * Any history of an anaphylactic reaction to human proteins, or monoclonal antibodies.
  9. * At screening, if participants do not meet the eligibility criteria assessed based on laboratory test results e.g tests for total bilirubin, serum creatinine etc.

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479
information.center@astrazeneca.com

Study Locations (Sites)

Research Site
Glendale, Arizona, 85306
United States
Research Site
Phoenix, Arizona, 85028
United States
Research Site
Covina, California, 91722
United States
Research Site
Fountain Valley, California, 92708
United States
Research Site
La Jolla, California, 92037
United States
Research Site
Los Angeles, California, 90045
United States
Research Site
Los Angeles, California, 90089
United States
Research Site
Orange, California, 92868
United States
Research Site
Orange, California, 92868
United States
Research Site
San Francisco, California, 94143
United States
Research Site
Aurora, Colorado, 80045
United States
Research Site
Denver, Colorado, 80230
United States
Research Site
New Haven, Connecticut, 06519
United States
Research Site
Washington D.C., District of Columbia, 20037
United States
Research Site
Fort Lauderdale, Florida, 33309
United States
Research Site
Miami, Florida, 33136
United States
Research Site
Miami, Florida, 33174
United States
Research Site
Plantation, Florida, 33324
United States
Research Site
Chicago, Illinois, 60611
United States
Research Site
Chicago, Illinois, 60637
United States
Research Site
Indianapolis, Indiana, 46202
United States
Research Site
Murray, Kentucky, 42071
United States
Research Site
Baltimore, Maryland, 21287
United States
Research Site
Boston, Massachusetts, 02114
United States
Research Site
Boston, Massachusetts, 02115-5817
United States
Research Site
Ann Arbor, Michigan, 48103
United States
Research Site
Ann Arbor, Michigan, 48109
United States
Research Site
Bloomfield Hills, Michigan, 48302
United States
Research Site
Rochester, Minnesota, 55905
United States
Research Site
Omaha, Nebraska, 68198-5885
United States
Research Site
Midland Park, New Jersey, 07432
United States
Research Site
Brooklyn, New York, 11201
United States
Research Site
New York, New York, 10016
United States
Research Site
New York, New York, 10028
United States
Research Site
Rochester, New York, 14642
United States
Research Site
Chapel Hill, North Carolina, 27516
United States
Research Site
Charlotte, North Carolina, 28207
United States
Research Site
Statesville, North Carolina, 28625
United States
Research Site
Cleveland, Ohio, 44124
United States
Research Site
Cleveland, Ohio, 44195
United States
Research Site
Portland, Oregon, 97239
United States
Research Site
Philadelphia, Pennsylvania, 19104
United States
Research Site
Providence, Rhode Island, 02903
United States
Research Site
Charleston, South Carolina, 29425
United States
Research Site
Summerville, South Carolina, 29486
United States
Research Site
Dallas, Texas, 75390-8843
United States
Research Site
Galveston, Texas, 77555
United States
Research Site
Mesquite, Texas, 75150
United States
Research Site
Charlottesville, Virginia, 22903
United States
Research Site
Roanoke, Virginia, 24016
United States
Research Site
Seattle, Washington, 98105
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-29
Study Completion Date2027-08-22

Study Record Updates

Study Start Date2024-06-29
Study Completion Date2027-08-22

Terms related to this study

Keywords Provided by Researchers

  • Lupus erythematosus
  • Cutaneous lupus erythematosus
  • Anifrolumab
  • Cutaneous Lupus Erythematosus Disease Area Severity Index
  • Subacute lupus
  • Discoid lupus

Additional Relevant MeSH Terms

  • Cutaneous Lupus Erythematosus