Study on the Effects of Obexelimab for Patients with IgG4-Related Disease

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What is this study about?

This clinical trial is focused on studying a condition known as IgG4-Related Disease, which is a rare disorder that can cause inflammation in various parts of the body. The study is testing a treatment called Obexelimab, which is given as an injection under the skin. The purpose of the study is to evaluate how effective and safe Obexelimab is for patients with this disease.

Participants in the study will receive either Obexelimab or a placebo, which is a solution that looks like the treatment but does not contain the active medicine. The study will last for about a year, during which participants will receive weekly injections. The study aims to see if Obexelimab can help prevent flare-ups of the disease, which are times when symptoms get worse.

Throughout the study, the safety and tolerability of Obexelimab will be closely monitored. This means that researchers will keep track of any side effects or health changes that occur. The study will also look at how often flare-ups happen and how much additional treatment is needed to manage them. Participants will have regular check-ups to assess their health and the effects of the treatment.

1 Initial Glucocorticoid Treatment Phase

Upon joining the study, the patient will begin an initial course of treatment with glucocorticoids (also known as GC). Glucocorticoids are medications that reduce inflammation in the body.

This initial treatment phase is designed to control the active symptoms of IgG4-Related Disease (a rare condition where the immune system causes inflammation in various organs).

2 Randomization to Treatment Groups

After completing the initial glucocorticoid treatment, the patient will be randomly assigned to one of two treatment groups. This process is called randomization, and it works like a coin toss to determine which treatment the patient will receive.

Neither the patient nor the study doctor will know which treatment group the patient is in. This is called a double-blind study design.

The patient will receive either obexelimab (the medication being tested) or a placebo (an inactive substance that looks like the real medication but contains no active drug).

3 Weekly Injections for 52 Weeks

The patient will receive weekly injections under the skin (called subcutaneous injections or SC injections) for a period of 52 weeks (approximately one year).

If assigned to the obexelimab group, each injection will contain 250 mg of obexelimab.

If assigned to the placebo group, each injection will contain a sterile solution without any active medication.

These injections will be administered once every week throughout the entire 52-week period.

4 Regular Monitoring and Assessments

Throughout the 52-week treatment period, the patient will attend regular study visits for monitoring and assessment.

During these visits, the study doctor will check for any signs of disease flare (when previous symptoms return or new symptoms appear).

The patient’s condition will be evaluated using the IgG4-RD Responder Index (a scoring system that measures disease activity).

The study team will monitor for any adverse events (unwanted or harmful reactions) and serious adverse events (more severe medical problems that may require hospitalization or medical attention).

5 Rescue Therapy if Needed

If the patient experiences a disease flare during the study, the study doctor may decide that rescue therapy is needed. Rescue therapy refers to additional treatment (typically glucocorticoids) given to control the flare.

The decision to start rescue therapy will be made by both the study doctor and an independent Adjudication Committee (a group of medical experts who review the patient’s condition).

If rescue therapy is required, the amount and timing of this additional medication will be recorded as part of the study.

6 Completion of Treatment Period at Week 52

After completing the full 52 weeks of weekly injections, the patient will reach the end of the main treatment period.

At this final visit (Week 52), the study doctor will perform a comprehensive assessment to determine if the patient has achieved complete remission. Complete remission means there has been no disease flare, no need for rescue therapy, and either no signs of active disease or a score of 0 on the IgG4-RD Responder Index.

The study team will review all safety information collected throughout the treatment period.

Who Can Join the Study?

You must be at least 18 years old
You must have a clinical diagnosis of IgG4-Related Disease, which is a rare condition where your immune system causes inflammation and damage in various organs
You must meet specific classification criteria established by medical organizations for IgG4-Related Disease with a score of at least 20 points
You must have active signs and symptoms of IgG4-Related Disease that require starting glucocorticoid therapy (steroid medication to reduce inflammation) or increasing your current long-term steroid dose
If you are a woman who could become pregnant, you must not be pregnant or breastfeeding at the time of enrollment
If you are a woman who could become pregnant, you must agree to use effective birth control methods during the study and for at least 8 weeks after receiving the last dose of study medication
If you are a woman who could become pregnant, you must agree not to donate eggs during the study and for at least 8 weeks after the last dose of study medication
If you are a man, you must agree to use effective birth control methods or abstain from sexual intercourse during the study and for at least 8 weeks after the last dose of study medication, unless you have had surgery that makes you unable to father children
If you are a man, you must agree not to donate sperm during the study and for at least 8 weeks after the last dose of study medication
If you are a woman who could become pregnant, you must have a negative pregnancy test before starting the study and at specified times throughout the study
You must be able to understand and sign an informed consent form, which means you agree to participate and follow the study rules
You must be willing to follow all study procedures and attend all required study visits
You must have been treated with glucocorticoids for at least 3 weeks but no more than 6 weeks before joining the study, at a daily dose between 20 and 60 milligrams

Who Cannot Join the Study?

You have disease affecting only one organ where the main problem is scarring or thickening of tissue, such as scarring around the kidneys, a rare thyroid condition called Riedel’s thyroiditis, scarring in the chest area, or scarring around the intestines
You have taken prednisone (a steroid medication used to reduce inflammation) at a dose higher than 60 mg per day within 4 weeks before starting the study or during the initial screening period
You have taken medications that suppress the immune system or treat rheumatological diseases (other than steroids) within 2 weeks before starting the study
You have participated in another research study and received an experimental treatment within 12 weeks before starting this study, or within a time period based on how long that treatment stays in your body
You have received a live vaccine (a type of vaccine containing weakened living organisms) or treatment with live infectious agents within 2 weeks before starting the study
You have active hepatitis B (a liver infection caused by a virus), active hepatitis C (another type of viral liver infection), or HIV (a virus that affects the immune system). You will be excluded if tests show current hepatitis B infection or certain antibodies indicating exposure to the virus
You have active tuberculosis (a bacterial infection usually affecting the lungs, also called TB) or are at high risk for tuberculosis, including if you have a history of tuberculosis that was not fully treated, a positive or unclear test result for tuberculosis, symptoms suggesting tuberculosis, or imaging scans showing possible tuberculosis
You have a history or current evidence of an unstable or uncontrolled medical condition affecting your heart, lungs, kidneys, liver, metabolism, blood, mental health, or an active infection that could put your safety at risk or interfere with the study
You have had cancer within the past 5 years, except for certain successfully treated cancers such as early cervical cancer, certain skin cancers, breast cancer with no return for at least 5 years, or prostate cancer with no return for at least 3 years
You meet other exclusion criteria specified in the detailed study protocol

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain

Other Sites

Site Name	City	Country
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy	Bydgoszcz	Poland
Ospedale San Raffaele S.r.l.	Milan	Italy
Hopital Beaujon	Clichy	France
University Of Szeged	Szeged	Hungary
University Of Pecs	Pecs	Hungary
Ospedale San Giovanni Bosco	Turin	Italy
Virgen del Rocío University Hospital	Sevilla	Spain
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Semmelweis University	Budapest	Hungary
Hospital Alvaro Cunqueiro	Vigo	Spain
Centro Ricerche Cliniche Di Verona S.r.l.	Verona	Italy
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Hospital Universitario 12 De Octubre	Madrid	Spain
Universita Degli Studi Di Brescia	Brescia	Italy
Centrum Medyczne Oporow	Wroclaw	Poland
Azienda Ospedaliero Universitaria Pisana	Pisa	Italy
Nrqhsakx Ifrkwdte Gtlykwvyu Rywfmbmolckr I Ryykossflvijj Ic Pxsqg Dz Hgtb Mgus Ekmsgpdz Reboxno	Warsaw	Poland
Csrert Hadhovwbgnt Usyrgwsvvfhwb Du Dyspd	Dijon	France
Aavmlunswo Pmepzepp Hztrgpwd Dg Milqfehyt	Marseille	France
Lahxxh Mblxuezdyj Ucfbqkbxnf Ot Mgwzng	Munich	Germany
Kryvtayu dea Uwufawvwfybm Mafapvoj Aky	Munich	Germany
Hxcuqfuh Dj Lk Soxbk Cilu I Stjs Pyi	Barcelona	Spain
Uvuyxbbvumvb Mapamya Cgsgnfy Gakaliatj	Groningen	The Netherlands
Htfyytex Vowk djfeirjb	Barcelona	Spain
Hesinodx Uekbmhniehoomy Sesizflxka &lduxsx Hukduat dw Hnpxvtbejck	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	09.06.2023
Germany	Not recruiting	09.06.2023
Hungary	Not recruiting	09.06.2023
Italy	Not recruiting	09.06.2023
Poland	Not recruiting	09.06.2023
Spain	Not recruiting	09.06.2023
Sweden	Not recruiting	09.06.2023
The Netherlands	Not recruiting	09.06.2023

Trial locations

Investigated drugs:

Obexelimab

Obexelimab is an investigational medication being tested to treat IgG4-related disease, a condition where the immune system causes inflammation and damage to various organs in the body. This medication works by targeting specific immune cells that are thought to be involved in causing the disease. It is given as an injection under the skin once a week. The goal is to see if obexelimab can help prevent the disease from getting worse or coming back after patients have been treated with steroid medications.

IgG4-Related Disease – IgG4-Related Disease is a rare immune system disorder characterized by abnormal growth of certain immune cells and the formation of masses or lesions in various organs throughout the body. The condition involves elevated levels of a specific type of antibody called immunoglobulin G4 (IgG4) in the blood. The disease typically causes swelling and inflammation in affected organs, which may include the pancreas, bile ducts, salivary glands, kidneys, lungs, and lymph nodes. The condition progresses through periods of active disease (flares) where new symptoms appear or previous symptoms return, alternating with periods of remission. During flares, patients may experience organ dysfunction, pain, and swelling in the affected areas. Without appropriate management, the inflammation can lead to scarring and permanent changes in the affected organs over time.

Trial ID:

2022-500718-24-00

Protocol code:

ZB012-03-001

NCT ID:

NCT05662241

Trial Phase:

Therapeutic confirmatory (Phase III)

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