BridgeMD
IVIG-Spare Trial
EU CTIS ID: 2024-513681-19-00
What this study is testing
To assess the proportion of patients in IVIG-free stable disease activity at week 16 after randomization across two study arms comparing Upadacitinib 30 mg vs Placebo.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Written informed consent
- 2. Female and male subjects ≥ 18 and <=65 years of age at the time of signing the informed consent
- 3. Patients with clinical diagnosis of idiopathic inflammatory myopathies (IIM; including PM, DM, IMNM, ASyS, OM)
- 4. Receiving IVIG at stable dose and interval for at least 12 weeks before screening
- 5. Stable disease activity according to the discretion of the treating physician for at least 3 months
- 6. Receiving a permitted background treatment for IIM including immunosuppressive drugs or antimalarials, corticosteroids (up to 10mg/day prednisone äquivalent ) with stable dose and interval for at least 12 weeks before enrollment
You likely can't join if
- 1. Conditions other than IIM requiring continuous or intermittent treatment with IVIG such as primary or secondary immune deficiencies.
- 18. Serologic evidence of current or past Hepatitis B, or Hepatitis C infection
- 19. Evidence of HIV infection and/or positive HIV antibodies
- 2. Other inflammatory rheumatic diseases (e.g. rheumatoid arthritis) that by discretion of investigator might interfere with conduction of the study
- 20. Positive QuantiFERON TB test, history of Tuberculosis, or active Tuberculosis-infection (without at least 4 weeks of adequate therapy for Tuberculosis and no history of re-exposure since their treatment was completed); patients must have no clinical features of active TB and have a screening chest x-ray with no evidence of active TB.
- 21. Are largely or wholly incapacitated permitting little or no self-care, such as being bedridden or confined to wheelchair
See the full eligibility criteria
Who can join
- 1. Written informed consent
- 2. Female and male subjects ≥ 18 and <=65 years of age at the time of signing the informed consent
- 3. Patients with clinical diagnosis of idiopathic inflammatory myopathies (IIM; including PM, DM, IMNM, ASyS, OM)
- 4. Receiving IVIG at stable dose and interval for at least 12 weeks before screening
- 5. Stable disease activity according to the discretion of the treating physician for at least 3 months
- 6. Receiving a permitted background treatment for IIM including immunosuppressive drugs or antimalarials, corticosteroids (up to 10mg/day prednisone äquivalent ) with stable dose and interval for at least 12 weeks before enrollment
- 7. Willing and being capable of understanding and following the study procedures
- 8. Female subjects agreeing to conduct efficient contraception, (unless they have no childbearing potential, means: o Women who are infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation o Women aged 55 years or older who are not on hormone therapy and who have had at least 6 months of spontaneous amenorrhea o Women aged 55 years or older who have a diagnosis of menopause o Women with amenorrhoe >12 months)
What rules you out
- 1. Conditions other than IIM requiring continuous or intermittent treatment with IVIG such as primary or secondary immune deficiencies.
- 18. Serologic evidence of current or past Hepatitis B, or Hepatitis C infection
- 19. Evidence of HIV infection and/or positive HIV antibodies
- 2. Other inflammatory rheumatic diseases (e.g. rheumatoid arthritis) that by discretion of investigator might interfere with conduction of the study
- 20. Positive QuantiFERON TB test, history of Tuberculosis, or active Tuberculosis-infection (without at least 4 weeks of adequate therapy for Tuberculosis and no history of re-exposure since their treatment was completed); patients must have no clinical features of active TB and have a screening chest x-ray with no evidence of active TB.
- 21. Are largely or wholly incapacitated permitting little or no self-care, such as being bedridden or confined to wheelchair
- 22. Any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening
- 23. Primary or secondary immunodeficiency (history of or currently active) unless related to primary disease under investigation
- 24. Any medical or psychological condition that in the opinion of the Principal Investigator would interfere with safe completion of the trial
- 25. History of any malignancy prior to screening and patients with an increased risk of malignancy, which, according to the investigator, would pose an unacceptable risk to the patient if participating in the study
- 26. Pregnant women or nursing (breast feeding) mothers
- 10. Previous treatment with a Janus kinase (JAK) inhibitor or tyrosine kinase (TYK) inhibitor (e.g. Baricitinib, Tofacitinib, Filgotinib, Deucravacitinib (an exception to this criterion may be granted for single dose exposure upon application to the sponsor on a case-by-case basis)
- 27. Female patients with reproductive potential not willing to use an effective method of contraception (e.g., abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, implantable or injectable contraceptives or surgical sterilisation) and are not willing to continue this precaution for the duration of the study until 6 months after receiving the last medication dose.
- 28. Have a history of intravenous drug abuse, other illicit drug abuse, or chronic alcohol abuse within the 2 years prior to screening or are concurrently using, or expected to use during the study, illicit drugs (including marijuana)
- 29. Neuropathies or other conditions that might interfere with pain evaluation unless related to primary disease under investigation
- 3. Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization.
- 30. Patients with lack of peripheral venous access
- 31. Patients with known allergy or intolerance to the study drug or its’ excipients
- 4. Screening electrocardiogram (ECG) abnormalities that, in the opinion of the investigator, are clinically significant and indicate an unacceptable risk for the patient´s participation in the study.
- 5. History of venous thromboembolism (VTE) including deep vein thrombosis (DVT) and pulmonary embolism (PE); myocardial infarction, unstable ischemic heart disease stroke, or New York Heart Association Stage III/IV heart failure.
- 6. History of recurrent (≥ 2) VTE (DVT/PE)
- 7. Past or current cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders, or any other serious and/or unstable illness that in the opinion of the investigator could constitute an unacceptable risk when taking investigational product or interfere with the interpretation of data.
- 11. Plasmapheresis within 12 weeks prior to screening.
- 8. History of gastrointestinal organ perforation.
- 9. Immunization with a live/attenuated vaccine within 12 weeks prior to baseline or are expected to need/receive a live vaccine during the course of the study (with the exception of herpes zoster vaccination at the discretion of the investigator).
- Patients currently smoking
- 12. Any of the following specific abnormalities on screening laboratory tests: a. ALT or AST >3 x ULN (if not explained by IIM disease activity) b. Alkaline phosphatase (ALP) >3 x ULN c. Total bilirubin ≥ 1.5 x ULN d. Hemoglobin <8 g/dL e. Total white blood cell count <2500 cells/µL (<2.50 x 103 / µL or <2.50 GI/L) f. Neutropenia (absolute neutrophil count [ANC] <1000 cells/ µL (<1.0 x 109/ L or <1.20 GI/L) g. Lymphopenia (lymphocyte count <500 cells/µL) (<0.5 x 109/L or <50GI/L) h. Thrombocytopenia (platelets <100,000 cells/µL) (<100 x 103/µL or <100 GI/L) i. eGFR <30 mL/min/1.73 m2 In the case of any of the aforementioned laboratory abnormalities, the test may be repeated once by the central laboratory during screening and values resulting from repeat testing may be accepted for enrolment eligibility if they meet the eligibility criterion
- 13. Severe hepatic impairment.
- 14. Current or recent (< 4 weeks prior to randomization) clinically serious viral, bacterial, fungal or parasitic infection or any other active or recent infection, that in the opinion of the investigator would pose an unacceptable risk to the patient if participating in the study
- 15. Symptomatic herpes simplex infection at the time of randomization
- 16. Symptomatic herpes zoster infection within 12 weeks prior to randomization
- 17. History of disseminated/complicated herpes zoster (for example, multidermatomal involvement, ophthalmic zoster, CNS involvement, or post-herpetic neuralgia)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.