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Granulomatosis With Polyangiitis (GPA)Phase 2IXchangeNCT03895801

Study of IFX-1 to Replace Steroids in Patients With Granulomatosis With Polyangiitis and Microscopic Polyangiitis.

A Phase 2 study testing IFX-1 and Glucocorticoid (GC) in people with Granulomatosis With Polyangiitis (GPA) and Microscopic Polyangiitis (MPA), run by InflaRx GmbH at 76 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of the study is to evaluate the efficacy of IFX-1 treatment as replacement for glucocorticoid (GC) therapy in subjects with polyangiitis (GPA) or microscopic polyangiitis (MPA). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
IFX-1 and Glucocorticoid (GC)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
57 participants
Where
76 sitesin 11 countries
Study dates
3 Apr 2019to 8 Jun 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA)
  • Have ≥ 1 "major" item, or ≥ 3 other items, or ≥ 2 renal items on the Birmingham Vasculitis Activity Score Version 3 (BVASv3).
  • Newly diagnosed or relapsed GPA or MPA that requires treatment with Cyclophosphamide (CYC) or Rituximab (RTX) plus GCs.
  • Glomerular filtration rate ≥ 20 mL/min/1.73 m².

Who cannot join

  • Any other multi-system autoimmune disease.
  • Require mechanical ventilation at screening.
  • Known hypersensitivity to any investigational medicinal product and/or any excipient.
  • Rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
  • Have required management of infections, as follows (a) Chronic infection requiring anti-infective therapy within 3 months before screening. (b) Use of intravenous antibacterials, antivirals, anti-fungals, or anti-parasitic agents within 30 days of screening
  • Current and/or history (within the previous 5 years) of drug and/or alcohol abuse and/or dependence.
Show all 21Show fewer
  • Evidence of Hep B, C and/ or HIV infection. Only subjects with documented negative historical results (within 4 weeks before screening) for Hep B,C Virus and HIV or a negative test by Screening can be included into the study.
  • Abnormal laboratory findings at screening
  • Current or history of malignancy, lymphoproliferative, or myeloproliferative disorder
  • Received CYC or RTX within 12 weeks before screening or within 12 weeks before CYC or RTX is started for remission induction within 2 weeks before screening.
  • Received > 3 g cumulative intravenous GCs within 4 weeks before screening.
  • Received an oral daily dose of a GC of > 10 mg prednisone-equivalent for more than 6 weeks continuously prior to screening.
  • Received an oral daily dose of a GC of > 80 mg prednisone equivalent within 2 weeks before screening.
  • Received a CD20 inhibitor, anti-tumor necrosis factor treatment, abatacept, alemtuzumab, any other experimental or biological therapy, intravenous immunoglobulin (Ig) or plasma exchange, antithymocyte globulin, or required renal dialysis within 12 weeks before screening.
  • Received a live vaccination within 4 weeks before screening
  • Either active or latent tuberculosis treatment is ongoing.
  • Pregnant or lactating.
  • Abnormal electrocardiogram.
  • Female subjects of childbearing potential unwilling or unable to use a highly effective method of contraception
  • Participation in an investigational clinical study during the 12 weeks before screening.
  • Male subjects with female partners of childbearing potential unwilling to use contraception

Trial locations and contacts

76 sites in 11 countries.

76 sites in 11 countries

Germany14 sites

  • Clinical Site

    Aachen

  • Clinical Site

    Berlin

  • Clinical Site

    Cologne

  • Clinical Site

    Dresden

  • Clinical Site

    Essen

  • Clinical Site

    Freiburg im Breisgau

  • Clinical Site

    Hanover

  • Clinical Site

    Jena, Thuringia

  • Clinical Site

    Kirchheim unter Teck

  • Clinical Site

    Leipzig

  • Clinical Site

    Ludwigshafen

  • Clinical Site

    Mannheim

  • Clinical Site

    Münster

  • Clinical Site

    Stuttgart

Other trials in Germany

France11 sites

  • Clinical Site

    Angers

  • Clinical Site

    Brest

  • Clinical Site

    Créteil

  • Clinical Site

    Grenoble

  • Clinical Site

    Lille

  • Clinical Site

    Montpellier

  • Clinical Site

    Paris, 75012

  • Clinical Site

    Paris, 75651

  • Clinical Site

    Paris, 75679

  • Clinical Site

    Pessac

  • Clinical Site

    Poitiers

Other trials in France

Spain10 sites

  • Clinical Site

    Alcorcón

  • Clinical Site

    Badalona

  • Clinical Site

    Barcelona, 08025

  • Clinical site

    Barcelona, 08036

  • Clinical Site

    Barcelona

  • Clinical Site

    Fuenlabrada

  • Clinical Site

    L'Hospitalet de Llobregat

  • Clinical Site

    Seville, 41010

  • Clinical Site

    Seville, 41013

  • Clinical Site

    Seville, 41014

Other trials in Spain

United Kingdom10 sites

  • Clinical Site

    Aberdeen

  • Clinical Site

    Cambridge

  • Clinical Site

    Cardiff

  • Clinical Site

    Leicester

  • Clinical Site

    London, NW3 2QG

  • Clinical Site

    London, SE1 9RT

  • Clinical Site

    Portsmouth

  • Clinical Site

    Preston

  • Clinical Site

    Reading

  • Clinical Site

    Sheffield

Other trials in United Kingdom

Italy9 sites

  • Clinical Site

    Catania

  • Clinical Site

    Lecco

  • Clinical Site

    Messina

  • Clinical Site

    Milan, 20132

  • Clinical Site

    Milan, 20153

  • Clinical Site

    Monza

  • Clinical Site

    Pavia

  • Clinical Site

    Pisa

  • Clinical Site

    Verona

Other trials in Italy

Russia9 sites

  • Clinical Site

    Kemerovo

  • Clinical Site

    Moscow, 119991

  • Clinical site

    Moscow, 121374

  • Clinical site

    Moscow, 129110

  • Clinical Site

    Orenburg

  • Clinical Site

    Petrozavodsk

  • Clinical site

    Saratov, 410039

  • Clinical Site

    Saratov, 410053

  • Clinical Site

    Yaroslavl

Other trials in Russia

Czechia4 sites

  • Clinical Site

    Hradec Králové

  • Clinical Site

    Prague, 128 08

  • Clinical Site

    Prague, 140 21

  • Clinical Site

    Prague, 150 06

Other trials in Czechia

Sweden3 sites

  • Clinical Site

    Gothenburg

  • Clinical Site

    Stockholm

  • Clinical Site

    Uppsala

Other trials in Sweden

Belgium2 sites

  • Clinical Site

    Leuven

  • Clinical Site

    Liège

Other trials in Belgium

Netherlands2 sites

  • Clinical Site

    Maastricht

  • Clinical Site

    Rotterdam

Other trials in Netherlands

Switzerland2 sites

  • Clinical Site

    Sankt Gallen

  • Clinical Site

    Zurich

Other trials in Switzerland

About this study

Official title: A Randomized, Double-blind, Double-dummy, Active-controlled, Multicenter, 2-part Phase II Study on Replacement of Steroids by IFX-1 in Active Granulomatosis With Polyangiitis (GPA) and Microscopic Polyangiitis (MPA)

The purpose of the study is to evaluate the efficacy of IFX-1 treatment as replacement for glucocorticoid (GC) therapy in subjects with polyangiitis (GPA) or microscopic polyangiitis (MPA).

Read the detailed description

Anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV) is a group of potentially life-threatening autoimmune diseases. Preclinical data demonstrate that primed neutrophils are activated by anti-neutrophil cytoplasmic antibody (ANCA) and generate C5a that engages C5a receptors on neutrophils. Patients with ANCA-related disease have elevated plasma and urine levels of C5a in active disease but not in remission. IFX-1 is as a monoclonal antibody specifically binding to the soluble human complement split product C5a, which results in nearly complete blockade of C5a induced biological effects. Therefore, IFX-1 may be effective in the treatment of subjects with AAV.

In this Phase II study of 20 to 55 subjects with granulomatosis with GPA and MPA, IFX-1 will be administered in combination with reduced dose glucocorticoids or a placebo glucocorticoid compared with standard dose glucocorticoids.

Being tested
IFX-1, Placebo-IFX-1, Glucocorticoid (GC), Placebo-Glucocorticoid (Placebo-GC)
Keywords
granulomatosis, polyangiitis, corticosteroid, replacement, glucocorticoid
Medical subject headings
Granulomatosis with Polyangiitis, Microscopic Polyangiitis, Systemic Vasculitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IFX-1Drug

    Also called CaCP29

    intravenously administered

  • Placebo-IFX-1Drug

    Also called Placebo

    intravenously administered

  • Glucocorticoid (GC)Drug

    Also called Prednisone

    orally administered

  • Placebo-Glucocorticoid (Placebo-GC)Drug

    Also called Placebo

    orally administered

Study groups in NCT03895801
Study groupRoleWhat they receive
Group A Experimental + active comparatorExperimentalIFX-1 + reduced dose GC
Receives: Drug: IFX-1; Drug: Glucocorticoid (GC)
Group B Placebo + active comparatorActive comparatorPlacebo-IFX-1 + standard dose GC
Receives: Drug: Placebo-IFX-1; Drug: Glucocorticoid (GC)
Group C Experimental + placebo comparatorPlacebo comparatorIFX-1 + Placebo-GC
Receives: Drug: IFX-1; Drug: Placebo-Glucocorticoid (Placebo-GC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Subjects Achieving Clinical Response

    Efficacy Endpoint: Percentage of subjects achieving clinical response (reduction in Birmingham Vasculitis Activity Score version 3 [BVASv3] of ≥50% compared to baseline and no worsening in any body system). Subjects who received rescue therapy after Day 1 or discontinued due to related adverse event, lack of efficacy or progressive disease are considered as non-responders at all subsequent visits. The BVASv3 score ranges from 0 to 63 with higher values representing higher disease activity.

    Measured: Baseline, Week 16

Secondary outcomes (11)

  1. Percentage of Subjects With Clinical Remission

    Efficacy endpoint: Percentage of subjects with clinical remission, defined as having a BVASv3 = 0. Subjects who received rescue therapy after Day 1 or discontinued due to related adverse event, lack of efficacy or progressive disease are considered as non-responders at all subsequent visits. The BVASv3 score ranges from 0 to 63 with higher values representing higher disease activity.

    Measured: Week 16

  2. Change From Baseline in BVASv3 Total Score

    Efficacy endpoint: Absolute Change from baseline (= screening assessment) in Birmingham Vasculitis Activity Score version 3 (BVASv3) total score; The BVASv3 score ranges from 0 to 63 with higher values representing higher disease activity. The total score is derived by summing up item scores according to the scoring manual for the BVASv3.

    Measured: Baseline, Week 16

  3. Vasculitis Damage Index (VDI)

    Efficacy endpoint: Absolute values of VDI; The VDI total score ranges from 0 to 64 with higher scores indicating more organ damage since the onset of vasculitis. The total score is the number of present damage items.

    Measured: Week 16

  4. Physician Global Assessment (PGA)

    Efficacy endpoint: Absolute values in PGA; Physician global assessment scale: 0 = Remission to 10 = Maximum activity;

    Measured: Week 16

  5. Estimated Glomerular Filtration Rate

    Efficacy endpoint: Absolute values of estimated glomerular filtration rate (eGFR) in mL/min/1.73 m²; The eGFR was calculated by the central laboratory according to the Modified Diet in Renal Disease equation:

    eGFR = 175 x (serum creatinine, mg/dL)-1.154 x (age, years)-0.203 x (0.742 if female) x (1.212 if black)

    Measured: Week 16

  6. Number and Percentage of Subjects Who Had a Treatment-emergent Adverse Event (TEAE)

    Safety endpoint: Number and percentage of subjects who had a treatment-emergent adverse event (TEAE)

    Measured: Week 24

  7. Glucocorticoid Toxicity Index (GTI)

    Safety endpoint: The GTI total score ranges from -35 to 410 (because the bone domain is excluded in this study) with higher score indicating greater Glucocorticoid toxicity. Scoring was performed in the electronic case report form according to the corresponding scoring manual in "Development of a Glucocorticoid Toxicity Index (GTI) using multicriteria decision analysis." by Miloslavsky EM, Naden RP, Bijlsma JW, Brogan PA, Brown ES, Brunetta P, et al.

    Measured: Week 16

  8. IFX-1 Plasma Concentrations (Pre-dose)

    Pharmacokinetics endpoint: IFX-1 plasma concentrations assessed prior to study drug administration at corresponding visit.

    Measured: Week 16 (pre-dose)

  9. Plasma Concentrations of C5a

    Pharmacodynamics endpoint: Plasma concentrations of C5a

    Measured: Week 16

  10. IFX-1 Blocking Activity 10 nM

    Pharmacodynamics endpoint: IFX-1 blocking activity 10 nM

    Measured: Week 16

  11. IFX-1 Blocking Activity 2.5 nM

    Pharmacodynamics endpoint: IFX-1 blocking activity 2.5 nM

    Measured: Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2019
  2. Study start3 Apr 2019
  3. Primary completion14 Apr 2021
  4. Study completion8 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03895801
Sponsor's protocol ID
IFX-1-P2.5
Acronym
IXchange
Status last verified
Aug 2022
First submitted
8 Mar 2019
Last updated
25 Aug 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IFX-1 and Glucocorticoid (GC) in people with Granulomatosis With Polyangiitis (GPA) and Microscopic Polyangiitis (MPA), run by InflaRx GmbH at 76 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in Germany, France, Spain, United Kingdom, Italy and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Subjects Achieving Clinical Response (time frame: Baseline, Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03895801.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2022.

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