Determine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY)

Study Purpose

The purpose of this study is to evaluate the efficacy and safety of treatment with subcutaneous anifrolumab versus placebo in adult participants with systemic sclerosis. The target population for this study includes patients who meet the 2013 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification for systemic sclerosis, either limited or diffuse cutaneous subsets, with a disease duration of less than 6 years from first non-Raynaud's phenomenon symptom.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
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

More Inclusion & Exclusion Criteria

Key

Inclusion Criteria:

1. Adult patients from 18 to 70 years of age inclusive. 2. Systemic sclerosis according to 2013 ACR/EULAR classification criteria. 3. Limited or diffuse cutaneous subsets. 4. Systemic sclerosis disease duration within 6 years from first non-Raynaud's phenomenon manifestation at the time of signing the ICF. 5. Either HAQ-DI score ≥ 0.25 points or PtGA score ≥ 3 points. 6. mRSS > 10 with early disease or rapid progression as defined by the protocol. 7. mRSS ≥ 15 with disease duration ≥ 18 months and active disease as defined by the protocol. 8. Stable background therapies can be used including hydroxychloroquine, methotrexate, azathioprine, mycophenolate mofetil, mycophenolate sodium, mycophenolic acid, oral glucocorticoids or tacrolimus. 9. Women of childbearing potential with a negative urine pregnancy test. 10. Uninvolved skin at injection sites.Key

Exclusion Criteria:

1. Anticentromere antibody seropositivity on central laboratory. 2. Severe cardiopulmonary disease as defined by the protocol. 3. History of systemic sclerosis renal crisis within past 12 months (estimated glomerular filtration rate(eGFR) < 45 mL/min/1.73m2) 4. Overlap syndromes, systemic lupus erythematosus with anti-double-stranded deoxyribonucleic acid antibody seropositivity or anti-citrullinated protein antibodies-positive rheumatoid arthritis, or SSc mimics (eg, scleromyxedema, eosinophilic fasciitis) 5. History of, or current, any other inflammatory diseases, eg, inflammatory bowel disease, skin disease, that, in the opinion of the investigator, could interfere with efficacy and safety assessments or require immunomodulatory therapy. 6. Evidence of moderately severe concurrent nervous system, renal, endocrine, hepatic (eg, underlying chronic liver disease [Child Pugh A, B, C hepatic impairment]), or gastrointestinal disease (eg, clinical signs of malabsorption or needing parenteral nutrition) not related to SSc, as determined by the investigator. 7. Hematopoietic stem cell transplantation or solid organ/limb transplantation. 8. Any severe case of Herpes Zoster infection as defined by the protocol. 9. Known malignancy or a history of malignancy within 5 years, with exception of excised/cured local basal or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix. 10. Major surgery within 8 weeks prior to and/or during study enrollment. 11. Known active current or history of recurrent infections. 12. Any condition that, in the opinion of the investigator or AstraZeneca, would interfere with the efficacy or safety evaluation of the study intervention or put participant at safety risk

Trial Details

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.	NCT05925803
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
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	AstraZeneca
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
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Austria, Belgium, Canada, China, France, Germany, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Poland, Puerto Rico, Romania, South Africa, South Korea, Spain, Turkey (Türkiye), United Kingdom, United States, Vietnam
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Systemic Sclerosis, Scleroderma

Additional Details

This is a multicenter, randomized, double-blind, placebo-controlled, Phase III study to evaluate the efficacy and safety of anifrolumab in the treatment of adult participants with Systemic Sclerosis (SSc) who may be taking one or a combination of protocol-specified standard therapies. The use of one of the following standard immunosuppressant therapies is permitted at a stable dose, but not mandated: hydroxychloroquine, mycophenolate mofetil (MMF), mycophenolic acid or mycophenolate sodium (MPA/MPS), methotrexate, azathioprine, tacrolimus, and oral glucocorticoids. MMF or MPA/MPS, azathioprine, and methotrexate may be used in combination with hydroxychloroquine and/or low-dose oral glucocorticoids [≤ 10 mg/day]. Approximately 306 eligible participants will be randomized in a 1:1 ratio to receive either anifrolumab (or matching placebo) given subcutaneously once weekly for 52 weeks. The study will be stratified by the following factors:

- Interstitial lung disease (ILD) (yes, no) at Week 0 (Day1); - MMF or MPA/MPS use (yes ,no) at Week 0 (Day 1); and.

- Disease duration, defined as the time from the first non-Raynaud's symptom attributable to SSc (<18 months, ≥ 18 months) at Week 0 (Day 1) Study treatment will be administered subcutaneously via an accessorized prefilled syringe by study staff or by the participant or carer, either in the clinic or at home, with most doses being administered at home.

The study consists of 4 periods: a 6-week screening period, a 52-week, double-blind, placebo-controlled period, a 52-week open-label active treatment period, and a 12-week safety follow-up period. There are a total of 16 study visits with most visits in the treatment period occurring every 8 to 12 weeks. The periods are described below:

- Screening Period: This may involve one or more visits to the study site.

- Double Blind Treatment Period: Treatment Period when participants will receive once weekly injections of anifrolumab or matching placebo.

Participation will involve in-clinic study visits at Weeks 0 (Day 1), 1, 4, 8*, 16, 24, 36, 48 and 52. *The visit at Week 8 may be either by telephone or in person.

- Open Label Treatment Period: At Week 52, all participants will be given anifrolumab (subcutaneous) once weekly for 52 weeks (last dose at Week 103).

Participation will involve in-clinic study visits at Weeks 52, 53*, 56, 64, 76. 88 and 104. *The visit at Week 53 may be either by telephone or in person.

- Safety Follow-up Period: All participants will return to the clinic for a 12-week post treatment visit.

This will occur post Double Blind Treatment Period (Week 52 or Double Blind Period early discontinuation) or post Open Label Treatment Period (Week 104 or Open Label Period early discontinuation).

Arms & Interventions

Arms

Experimental: Anifrolumab (subcutaneous weekly injection)

Anifrolumab subcutaneous injection once weekly

Placebo Comparator: matched placebo control (subcutaneous weekly injection)

matched placebo control subcutaneous injection once weekly

Interventions

Combination Product: - Anifrolumab (blinded)

Anifrolumab treatment delivered subcutaneously, once weekly for 52 weeks

Drug: - Placebo (blinded)

matched placebo delivered subcutaneously, once weekly for 52 weeks

Combination Product: - Anifrolumab (unblinded, open label)

At Week 52, all patients will receive Anifrolumab subcutaneously once weekly for 52 weeks

Contact a Trial Team

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Research Site, Birmingham 4049979, Alabama 4829764

Status

Recruiting

Address

Research Site

Birmingham 4049979, Alabama 4829764, 35205

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