RecruitingPHASE2INTERVENTIONAL

A Phase 2 Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases

This research study is looking into two new medicines, inebilizumab and blinatumomab, for adults living with certain autoimmune diseases. Specifically, it's focusing on Systemic Lupus Erythematosus (SLE), especially when it affects the kidneys (nephritis), and Rheumatoid Arthritis (RA). The main aim is to carefully examine how safe these new treatments are and whether participants experience any side effects. It also wants to see if blinatumomab can help improve the symptoms and condition of people with SLE and RA, particularly when current treatments haven't worked well enough. By understanding these treatments better, scientists hope to find new ways to help people manage these long-term conditions.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Amgen

Enrolment target

220

Start

16 Jul 2025

Estimated completion

21 Jul 2028

Systemic Lupus Erythematosus Active Refractory Rheumatoid Arthritis

What is this study about?

This study is a special kind of research designed to test new medicines for people with certain long-term health conditions. The conditions being looked at here are Systemic Lupus Erythematosus (often called SLE or just lupus) and Rheumatoid Arthritis (RA). Both of these are autoimmune diseases, meaning the body's immune system mistakenly attacks its own healthy tissues.

The main goal of this particular study, called a 'Phase 2 Master Protocol', is to see how safe two new medicines, inebilizumab and blinatumomab, are. It's also checking how well people can tolerate these medicines, meaning if they cause uncomfortable side effects. For blinatumomab, the study also aims to see if it's effective in improving symptoms for people who haven't responded well to other treatments.

Understanding how safe and effective these new treatments are is really important. If successful, these medicines could eventually offer new options for people whose current treatments aren't fully controlling their SLE or RA, potentially improving their quality of life. This research helps gather crucial information before a medicine can be widely used.

Key takeaways

New medicines (inebilizumab and blinatumomab) are being tested for SLE and RA.
The study focuses on safety and whether the medicines improve symptoms.
It's for adults with active SLE (including kidney involvement) or active RA, whose conditions haven't responded well to other treatments.
One part of the study (Subprotocol B) is no longer recruiting participants.
Taking part means contributing to new medical knowledge and potentially trying a new treatment.

Who may be eligible?

This study is looking for adults aged 18 to 75. To join, you would need to have a confirmed diagnosis of Systemic Lupus Erythematosus (SLE), based on specific criteria. For some parts of the study, your SLE would also need to be affecting your kidneys.

You would also need to have certain 'autoantibodies' in your blood, which are markers indicating your immune system is attacking your own body. Your SLE would need to be active and not responding well enough to your current treatments. Some parts of the study are also looking for people with Rheumatoid Arthritis whose condition is active and hasn't improved with other treatments.

It's important to know that one specific part of the study (Subprotocol B) is no longer inviting new participants.

Quick self-check

Are you between 18 and 75 years old?
Do you have a confirmed diagnosis of Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA)?
Is your SLE or RA currently active and not fully controlled by your usual treatments?
For SLE, do you have certain immune system markers (autoantibodies) in your blood?
Are you able to attend regular clinic visits for monitoring and treatment?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

The detailed information about what taking part would involve hasn't been fully provided in this summary. However, typically, participating in a clinical trial like this would involve:

* **Regular Visits:** You would likely have frequent visits to a clinic or hospital for check-ups, blood tests, and other assessments. * **Study Medication:** You would receive either inebilizumab or blinatumomab as part of the study. How these are given (e.g., injection, infusion) and how often would be explained. * **Health Monitoring:** Your health would be carefully monitored throughout the study, including tracking your symptoms, how well the treatment is working, and any side effects. * **Follow-up:** After finishing the main treatment period, there would likely be a follow-up period to continue monitoring your health. * **Duration:** The total length of your participation would depend on the specific part of the study you join, but clinical trials often last weeks, months, or even longer.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as receiving new treatments before they are widely available and potentially improving your condition if current treatments haven't been effective. You also contribute to medical knowledge that could help countless others. However, there are always potential risks, including side effects from the new medicines, which may be mild or serious. The new treatments might also not work for you, or they might not be better than your current treatment. Your health would be closely monitored, and you would have the full right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (54)

HonorHealth Research and Innovation Institute
Scottsdale, United States· Recruiting
University of Colorado
Aurora, United States· Recruiting
Vida Research Center
Hialeah, United States· Terminated
Homestead Associates In Research Inc
Homestead, United States· Terminated
Vitaly Clinical Research
Miami, United States· Terminated
Bioresearch Partner Coral Terrace
South Miami, United States· Recruiting
University Medical Center New Orleans
New Orleans, United States· Recruiting
Massachusetts General Hospital
Boston, United States· Recruiting
Mayo Clinic
Rochester, United States· Recruiting
Northwell Health
Great Neck, United States· Recruiting
Westchester Medical Center
Hawthorne, United States· Recruiting
Columbia University Medical Center
New York, United States· Recruiting

+42 more sites — see the official record for the full list.

Common questions

What is Systemic Lupus Erythematosus (SLE)?

SLE, or lupus, is a long-term autoimmune disease where your immune system mistakenly attacks healthy tissues in your body, potentially affecting many organs.

What is Rheumatoid Arthritis (RA)?

RA is an autoimmune disease mainly affecting your joints, causing pain, swelling, and stiffness.

What does 'refractory' mean in this study?

It means your condition (SLE or RA) has not responded well enough to standard or multiple previous treatments.

What is the main purpose of a 'Phase 2' study?

Phase 2 studies primarily aim to check the safety of a new medicine and to understand if it shows promise in treating a condition, often for specific patient groups.

Will I definitely get one of the new medicines if I join?

In this type of study, participants usually receive either the new medicine or sometimes a 'placebo' (a dummy medicine) or an existing standard treatment, to allow for comparison. You should discuss this with the study team.

How to find out more

Amgen Call Center

medinfo@amgen.com 866-572-6436 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.