A 2-stage, Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus
Study Purpose
This study aims to evaluate the efficacy and safety of subcutaneous (SC) anifrolumab versus placebo in adult participants with cutaneous lupus erythematosus (CLE).
Recruitment Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 18 Years - 70 Years |
| Gender | All |
Key
inclusion criteria:
- - Participants must have a confirmed diagnosis of CLE.
- - CLASI-A total score ≥ 10 points at Screening and confirmed at randomization.
- - CLA-IGA-R erythema score of ≥ 3 and CLA-IGA-R-OMC score of ≥ 1 at Screening and confirmed at randomization.
- - Inadequate response or intolerant to antimalarial therapy.
- - 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.
- - Contraceptive use by males and females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- - Participants should have a coronavirus disease 2019 (COVID-19) negative PCR or antigen test result as per local policies at Screening.
exclusion criteria:
- - History or evidence of suicidal ideation.
- - Severe or life-threatening Systemic lupus erythematosus (SLE).
- - Active SLE or Sjögren's Syndrome.
- - Any active skin conditions other than CLE that may interfere with the study.
- - History of recurrent infection requiring hospitalization and IV antibiotics.
- - COVID-19 infection.
- - Any history of an anaphylactic reaction to human proteins, or monoclonal antibodies.
- - At screening, if participants do not meet the eligibility criteria assessed based on laboratory test results e.
Trial Details
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Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT06015737 |
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Phase
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 (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
AstraZeneca |
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Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
N/A |
| Principal Investigator Affiliation | N/A |
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Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
| Overall Status | Not yet recruiting |
| Countries | Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Denmark, France, Germany, Greece, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Philippines, Poland, Serbia, South Africa, Spain, Taiwan, United Kingdom, United States |
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Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Cutaneous Lupus Erythematosus |
The primary objectives of the study are to evaluate the efficacy of anifrolumab compared with placebo in reducing skin disease in participants with active chronic and/or subacute CLE who are refractory and/or intolerant to antimalarial therapy. The secondary objectives of the study are to evaluate additional efficacy parameters of anifrolumab, safety, tolerability, quality of life, pharmacokinetics, pharmacodynamics, and immunogenicity. Stage 1 and Stage 2 of the study will have broadly identical study designs with the exception of sample size. Both Stages of the study will have a randomized, double-blind, placebo-controlled design, followed by an open-label treatment period.
Arms
Experimental: Stage 1: Anifrolumab
The participants will receive anifrolumab as a SC injection from Week 0/Day 1 up to and including week 51.
Placebo Comparator: Stage 1: Placebo
The participant will receive placebo as a SC injection from Week 0/Day 1 to Week 23. From Week 24 the participants will receive anifrolumab up to and including Week 51.
Experimental: Stage 2: Anifrolumab
The participants will receive anifrolumab as a SC injection from Week 0/Day 1 up to and including week 51.
Placebo Comparator: Stage 2: Placebo
The participant will receive placebo as a SC injection from Week 0/Day 1 to Week 23. From Week 24 the participants will receive anifrolumab up to and including Week 51.
Interventions
Combination Product: - Anifrolumab
Anifrolumab will be provided as a solution for injection in accessorized pre-filled syringe (aPFS).
Other: - Placebo
Matching placebo solution for injection in aPFS.
Combination Product: - Anifrolumab
Anifrolumab will be provided as a solution for injection in accessorized pre-filled syringe (aPFS).
Other: - Placebo
Matching placebo solution for injection in aPFS.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
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La Jolla, California, 92037
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Orange, California, 92868
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New Haven, Connecticut, 06519
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Fort Lauderdale, Florida, 33309
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Plantation, Florida, 33324
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Boston, Massachusetts, 02115-5817
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Ann Arbor, Michigan, 48109
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Brooklyn, New York, 11201
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Rochester, New York, 14642
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Charlottesville, Virginia, 22903
International Sites
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Ciudad de Buenos Aires, , 1221
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Belo Horizonte, , 30150-221
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Chambray Les Tours, , 37170
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Toulouse Cedex 9, , 31059
