A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD5492 in Adult Participants With Systemic Lupus Erythematosus or Idiopathic Inflammatory Myopathies or Rheumatoid Arthritis.
This research study is testing a new medication called AZD5492 for adults living with Systemic Lupus Erythematosus (lupus), Idiopathic Inflammatory Myopathies (a type of muscle inflammation), or Rheumatoid Arthritis. It's an early-stage study (Phase 1), focusing on understanding if the treatment is safe, how well people tolerate it, and how the body handles the medicine. Participants will receive AZD5492 as an injection under the skin. The study will last at least 180 days, with potential for longer follow-up, to carefully monitor participants and gather important information about this potential new therapy. This helps researchers decide if it's safe to test further.
نظرة سريعة
ما هو موضوع هذه الدراسة؟
This study is about a new potential medicine named AZD5492. We're looking into this treatment for adults who have Systemic Lupus Erythematosus (lupus), Idiopathic Inflammatory Myopathies (IIM, which causes muscle inflammation), or Rheumatoid Arthritis (RA, involving joint inflammation). These are conditions where the body's immune system mistakenly attacks healthy tissues.
The main goal of this early-stage study, called Phase 1, is to find out if AZD5492 is safe for people to take and how well their bodies cope with it. We also want to understand how the medicine behaves inside the body – how it's absorbed, distributed, and eventually leaves the body, and what effects it has. This information is crucial for deciding if AZD5492 is promising enough to continue testing in larger studies.
This study is split into two parts. In the first part, a single dose of AZD5492 will be given to participants with lupus, and the dose will be gradually increased in different groups. The second part will involve two doses given a week apart, to participants with lupus, IIM, or RA. This careful approach helps us learn about the medicine's effects step-by-step, always prioritising participant safety.
النقاط الرئيسية
- Tests AZD5492 for lupus, myositis, and rheumatoid arthritis.
- Focuses on safety, how the body handles the drug, and side effects.
- Participants will receive AZD5492 as an injection under the skin.
- Study lasts at least 180 days, with regular clinic visits.
- Open to adults aged 18-70 with active disease and limited success with other treatments.
- المشاركة طوعية، ويمكنك الانسحاب في أي وقت.
من قد يكون مؤهلاً؟
To be considered for this study, you must be an adult between 18 and 70 years old.
If you have Systemic Lupus Erythematosus (lupus), you need to have a confirmed diagnosis and your lupus should be active and moderately to severely affecting you. Also, your current treatments shouldn't be working well enough or you might have struggled with side effects from at least three different past treatments.
If you have Idiopathic Inflammatory Myopathies (IIM), you must have a 'probable' or 'definite' diagnosis of certain types of IIM, but not others like inclusion body myositis. Your muscle inflammation needs to be active and you should have tried standard treatments, including at least one biologic medicine, immunoglobulin, or cyclophosphamide, without good results or with side effects. Similarly, if you have Rheumatoid Arthritis, you'll need to meet specific criteria for diagnosis and active disease.
هل يمكن أن تناسبك هذه الدراسة؟
أجب عن هذه الأسئلة السريعة لترى ما إذا كنت مؤهلاً. هذا دليل فقط - الفريق البحثي هو الذي يتخذ القرار النهائي.
- هل عمرك بين 18 و 70 سنة؟
- Do you have a confirmed diagnosis of Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathies, or Rheumatoid Arthritis?
- Is your condition currently active (not fully controlled)?
- Have you tried and not responded well to, or experienced problems with, other standard treatments for your condition?
- Are you willing to attend regular study visits for at least 6 months?
ماذا يتضمن المشاركة؟
If you decide to take part, you'll first have a screening period that could last up to 42 days. During this time, doctors will check if the study is right for you. Depending on which part of the study you're in, you will receive the study medication, AZD5492, either once or twice (with the two doses given 7 days apart).
Your participation will last at least 180 days (about 6 months) after you receive the dose. You will have a number of study visits to the clinic to monitor your health. These visits will be more frequent at the beginning (for example, daily for a few days, then weekly), and then they will become less frequent. For example, in Part 1, visits are on Days 1 to 4, then Day 8, 15, 22, 30, 60, 90, 120, 150, and 180. Some participants might need to have follow-up visits for up to 12 months after the study starts. You'll have regular checks, blood tests, and other assessments to see how you're doing and how the medicine is affecting you.
المخاطر والفوائد المحتملة
المواقع (38)
- موقع البحثالرمز البريدي المؤكدAnniston, United States· التوظيف
- موقع البحثالرمز البريدي المؤكدبرمنغهام، الولايات المتحدة· منسحب
- موقع البحثالرمز البريدي المؤكدلا جولا، الولايات المتحدة· التوظيف
- موقع البحثالرمز البريدي المؤكدساكرامنتو، الولايات المتحدة· لم يبدأ التوظيف بعد
- موقع البحثالرمز البريدي المؤكدمدينة آيوا، الولايات المتحدة· التوظيف
- موقع البحثالرمز البريدي المؤكدأوماها، الولايات المتحدة· لم يبدأ التوظيف بعد
- موقع البحثالرمز البريدي المؤكدتشابل هيل، الولايات المتحدة· لم يبدأ التوظيف بعد
- موقع البحثالرمز البريدي المؤكدهاميلتون، كندا· التوظيف
- موقع البحثالرمز البريدي المؤكدشيربروك، كندا· التوظيف
- موقع البحثالرمز البريدي المؤكدبكين، الصين· التوظيف
- موقع البحثالرمز البريدي المؤكدShanghai, China· التوظيف
- موقع البحثالرمز البريدي المؤكدووهان، الصين· التوظيف
أسئلة شائعة
What is AZD5492?
AZD5492 is a new investigational medication being tested for conditions like lupus, myositis, and rheumatoid arthritis. It is not yet approved medicine.
How will I receive the medication?
AZD5492 will be given as an injection under your skin (subcutaneously).
كم من الوقت سأكون في الدراسة؟
You will be in the study for at least 180 days (about 6 months) after your dose, and potentially up to 12 months for additional follow-up visits.
هل سأعرف إذا كنت أحصل على الدواء الفعال؟
Yes, this is an 'open-label' study, which means everyone participating will receive AZD5492.
What is a Phase 1 study?
A Phase 1 study is an early stage of clinical research that primarily focuses on checking the safety and tolerability of a new medicine, and how the body handles it.
كيفية معرفة المزيد
مركز معلومات الدراسات السريرية لشركة أسترازينيكا
تحدث دائمًا إلى طبيبك العام أو الأخصائي قبل اتخاذ قرار بالمشاركة في دراسة.
هل أنت مهتم بالمشاركة؟
نقاش
مناقشة المجتمع
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