A Study to Evaluate the Safety and Effectiveness of IFX-1 in Add-on to Standard of Care in Patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA)

Overview

  • Study type

    Interventional
  • Study phase

    II
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 18-008714
    NCT ID: NCT03712345
    Sponsor Protocol Number: IFX-1-P2.6

About this study

The purpose of this study is to investigate the safety and tolerability of two dose regimens of IFX-1 as add-on to standard of care (SOC) in subjects with GPA and MPA compared with placebo.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Male or female.
  • ≥ 18 years of age.
  • Diagnosis of GPA or MPA according to the definitions of the Chapel Hill Consensus Conference. 
  • Have at least one "major" item, or at least three other items, or at least two renal items on the Birmingham Vasculitis Activity Score (BVAS) Version 3.0. 
  • New or relapsed GPA or MPA that require treatment with CYC or RTX plus GCs.

Exclusion Criteria: 

  • Any other multisystem autoimmune disease.
  • Requires mechanical ventilation because of alveolar hemorrhage at Screening.
  • Have required management of infections, as follows:
    • Chronic infection requiring suppressive anti-infective therapy (such as latent tuberculosis, pneumocystis, aspergillosis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria);
    • Use of intravenous antibacterials, antivirals, anti-fungals, or anti-parasitic agents.
  • Known or suspected active drug and/or alcohol abuse.
  • Human immunodeficiency virus (HIV), hepatitis B, or hepatitis C viral screening test showing evidence of active or chronic viral infection at Screening or a documented history of HIV, hepatitis B, or hepatitis C.
  • One of the following abnormal laboratory findings at Screening:
    • White blood cells < 3500/mm3
    • Platelet count < 120,000/mm3
    • Total bilirubin > 3 times the upper limit of normal (ULN)
    • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 x ULN
  • Acute or chronic liver disease.
  • Known hypersensitivity to inactive ingredients of the GC capsules.
  • History of or active malignancy, lymphoproliferative or myeloproliferative disorder. Individuals with squamous cell or basal cell carcinomas of the skin and individuals with cervical carcinoma in situ who have received curative surgical treatment may be eligible for this study.
  • History of anti-glomerular basement membrane (GBM) disease.
  • Received CYC or RTX within 12 weeks before screening; if on AZA, MMF, MPS, or MTX at the time of Screening, these drugs must be withdrawn prior to receiving CYC or RTX.
  • Received more than 3 g cumulative dose of intravenous GCs within 4 weeks before screening.
  • Received an oral daily dose of a GC of more than 10 mg prednisone-equivalent for more than 6 weeks continuously prior to screening.
  • Received CD20 inhibitor, anti-tumor necrosis factor treatment, abatacept, alemtuzumab, any other experimental or biological therapy, intravenous immunoglobulin or plasma exchange, antithymocyte globulin, or required dialysis within 12 weeks before Screening.
  • Received a live vaccination within 4 weeks before Screening or planned between Screening and Week 24.
  • Subjects with a history of tuberculosis.
  • Pregnant or lactating.
  • Clinically significant abnormal electrocardiogram (ECG) during Screening; e.g., QTcF >450 ms.
  • Female subjects of childbearing potential unwilling or unable to use a highly effective method of contraception (pearl index <1%) such as complete sexual abstinence, combined oral contraceptive, vaginal hormone ring, transdermal contraceptive patch, contraceptive implant, or depot contraceptive injection in combination with a second method of contraception such as condom, cervical cap, or diaphragm with spermicide during the study and for at least 4 weeks after last administration of IFX-1 (timeframes for SOC have to be considered as described in the respective Prescribing Information). Male subjects with female partners of childbearing potential unwilling to use contraception (condoms) during treatment and for at least 4 months after last administration of treatment.
  • Evidence or suspicion that the subject might not comply with the requirements of the study protocol.
  • Any other factor which, in the investigator’s opinion, is likely to compromise the subject’s ability to participate in the study.
  • The subject is an employee or direct relative of an employee at the study site or sponsor.
  • The subject is imprisoned or lawfully kept in an institution.
  • The subject has participated in an investigational clinical study during the 12 weeks (or five times the half-life of the previous IMP, whichever is longer) before Screening, or plans to participate in another investigational clinical study during their participation in this study.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Ulrich Specks, M.D.

Open for enrollment

Contact information:

Samantha Hughes CCRP

(507)226-1026

Hughes.Samantha@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20450958

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