Safety and Efficacy Study of IFX-1 in add-on to Standard of Care in Granulomatosis With Polyangiitis (GPA) and Microscopic Polyangiitis (MPA)

• Register: ClinicalTrials.gov
• Last refreshed on: 7 September 2021
• Main ID: NCT03712345
• Date of registration: 16/10/2018
• Prospective Registration: No
• Primary sponsor: InflaRx GmbH
• Public title: Safety and Efficacy Study of IFX-1 in add-on to Standard of Care in Granulomatosis With Polyangiitis (GPA) and Microscopic Polyangiitis (MPA)
• Scientific title: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase II Efficacy and Safety Study of IFX-1 in Add-On to Standard of Care in Granulomatosis With Polyangiitis (GPA) and Microscopic Polyangiitis (MPA)
• Date of first enrolment: October 15, 2018
• Target sample size: 19
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03712345
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2

Countries of recruitment

Canada, United States

Contacts

• Name: Peter A. Merkel, MD, MPH
• Affiliation: University of Pennsylvania

• Name: Korinna Pilz, MD, MS
• Affiliation: InflaRx GmbH

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Male or female, =18 years of age.

2. Diagnosis of GPA or MPA according to the definitions of the Chapel Hill Consensus
Conference.

3. 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.

4. New or relapsed GPA or MPA that require treatment with CYC or RTX plus GCs.

Exclusion Criteria:

1. Any other multisystem autoimmune disease

2. Requires mechanical ventilation because of alveolar hemorrhage at Screening.

3. Human immunodeficiency virus, hepatitis B, or hepatitis C viral screening test showing
evidence of active or chronic viral infection at Screening or a documented history of
the human immunodeficiency virus, hepatitis B, or hepatitis C.

4. Received CYC or RTX 12 weeks before Screening; if on azathioprine (AZA), methotrexate
(MTX), mycophenolate mofetil (MMF), or mycophenolate sodium (MPS) at the time of
Screening, these drugs must be withdrawn prior to receiving CYC or RTX.

5. Received more than 3 g cumulative high dose intravenous GCs within 4 weeks before
Screening.

6. On an oral dose of a GC of more than 10 mg prednisone equivalent at Screening or for
more than 6 weeks before Screening.

7. Received a 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.

8. Received a live vaccination within 4 weeks before Screening or planned between
Screening and Week 24.

9. 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).



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Granulomatosis With Polyangiitis (GPA)

Microscopic Polyangiitis (MPA)

Intervention(s)

Drug: Placebo

Drug: IFX-1

Primary Outcome(s)

Number and percentage of subjects who experience at least one treatment-emergent adverse event (TEAE) per treatment group. [Time Frame: Week 24]

Secondary Outcome(s)

IFX 1 concentration at predose (0 hours), after the end of the infusion (+10minutes), and at 2, 6, 24, and 48 hours after the start of the infusion for subjects in the PK substudy [Time Frame: Weeks 1, 4 and 16]

Proportion of subjects achieving clinical response (reduction in BVAS of =50% and no worsening in any body system) [Time Frame: Week 16]

IFX 1 concentration pre- and postdose at each IMP administration visit [Time Frame: Week 0 to Week 16, Week 20 and Week 24]

Proportion of subjects with clinical remission (BVAS = 0) [Time Frame: Week 16]

Secondary ID(s)

IFX-1-P2.6

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Iqvia Pty Ltd