IXchange: Study of IFX-1 to Replace Steroids in Patients With Granulomatosis With Polyangiitis and Microscopic Polyangiitis.
Sponsor
InflaRx GmbH (Industry)
Overall Status
Completed
CT.gov ID
NCT03895801
Collaborator
(none)
57
76
3
26.2
0.8
0
Study Details
Study Description
Brief 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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
57 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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)
Actual Study Start Date
:
Apr 3, 2019
Actual Primary Completion Date
:
Apr 14, 2021
Actual Study Completion Date
:
Jun 8, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group A Experimental + active comparator IFX-1 + reduced dose GC |
Drug: IFX-1
intravenously administered
Other Names:
Drug: Glucocorticoid (GC)
orally administered
Other Names:
|
| Active Comparator: Group B Placebo + active comparator Placebo-IFX-1 + standard dose GC |
Drug: Placebo-IFX-1
intravenously administered
Other Names:
Drug: Glucocorticoid (GC)
orally administered
Other Names:
|
| Placebo Comparator: Group C Experimental + placebo comparator IFX-1 + Placebo-GC |
Drug: IFX-1
intravenously administered
Other Names:
Drug: Placebo-Glucocorticoid (Placebo-GC)
orally administered
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Subjects Achieving Clinical Response [Baseline, Week 16]
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.
Secondary Outcome Measures
- Percentage of Subjects With Clinical Remission [Week 16]
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.
- Change From Baseline in BVASv3 Total Score [Baseline, Week 16]
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.
- Vasculitis Damage Index (VDI) [Week 16]
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.
- Physician Global Assessment (PGA) [Week 16]
Efficacy endpoint: Absolute values in PGA; Physician global assessment scale: 0 = Remission to 10 = Maximum activity;
- Estimated Glomerular Filtration Rate [Week 16]
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)
- Number and Percentage of Subjects Who Had a Treatment-emergent Adverse Event (TEAE) [Week 24]
Safety endpoint: Number and percentage of subjects who had a treatment-emergent adverse event (TEAE)
- Glucocorticoid Toxicity Index (GTI) [Week 16]
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.
- IFX-1 Plasma Concentrations (Pre-dose) [Week 16 (pre-dose)]
Pharmacokinetics endpoint: IFX-1 plasma concentrations assessed prior to study drug administration at corresponding visit.
- Plasma Concentrations of C5a [Week 16]
Pharmacodynamics endpoint: Plasma concentrations of C5a
- IFX-1 Blocking Activity 10 nM [Week 16]
Pharmacodynamics endpoint: IFX-1 blocking activity 10 nM
- IFX-1 Blocking Activity 2.5 nM [Week 16]
Pharmacodynamics endpoint: IFX-1 blocking activity 2.5 nM
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
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.
Exclusion Criteria:
-
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.
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinical Site | Leuven | Belgium | ||
| 2 | Clinical Site | Liège | Belgium | ||
| 3 | Clinical Site | Hradec Králové | Czechia | ||
| 4 | Clinical Site | Prague | Czechia | 150 06 | |
| 5 | Clinical Site | Praha | Czechia | 128 08 | |
| 6 | Clinical Site | Praha | Czechia | 140 21 | |
| 7 | Clinical Site | Angers | France | ||
| 8 | Clinical Site | Brest | France | ||
| 9 | Clinical Site | Créteil | France | ||
| 10 | Clinical Site | Grenoble | France | ||
| 11 | Clinical Site | Lille | France | ||
| 12 | Clinical Site | Montpellier | France | ||
| 13 | Clinical Site | Paris | France | 75012 | |
| 14 | Clinical Site | Paris | France | 75651 | |
| 15 | Clinical Site | Paris | France | 75679 | |
| 16 | Clinical Site | Pessac | France | ||
| 17 | Clinical Site | Poitiers | France | ||
| 18 | Clinical Site | Jena | Thüringen | Germany | |
| 19 | Clinical Site | Aachen | Germany | ||
| 20 | Clinical Site | Berlin | Germany | ||
| 21 | Clinical Site | Dresden | Germany | ||
| 22 | Clinical Site | Essen | Germany | ||
| 23 | Clinical Site | Freiburg | Germany | ||
| 24 | Clinical Site | Hannover | Germany | ||
| 25 | Clinical Site | Kirchheim unter Teck | Germany | ||
| 26 | Clinical Site | Köln | Germany | ||
| 27 | Clinical Site | Leipzig | Germany | ||
| 28 | Clinical Site | Ludwigshafen | Germany | ||
| 29 | Clinical Site | Mannheim | Germany | ||
| 30 | Clinical Site | Münster | Germany | ||
| 31 | Clinical Site | Stuttgart | Germany | ||
| 32 | Clinical Site | Catania | Italy | ||
| 33 | Clinical Site | Lecco | Italy | ||
| 34 | Clinical Site | Messina | Italy | ||
| 35 | Clinical Site | Milano | Italy | 20132 | |
| 36 | Clinical Site | Milano | Italy | 20153 | |
| 37 | Clinical Site | Monza | Italy | ||
| 38 | Clinical Site | Pavia | Italy | ||
| 39 | Clinical Site | Pisa | Italy | ||
| 40 | Clinical Site | Verona | Italy | ||
| 41 | Clinical Site | Maastricht | Netherlands | ||
| 42 | Clinical Site | Rotterdam | Netherlands | ||
| 43 | Clinical Site | Kemerovo | Russian Federation | ||
| 44 | Clinical Site | Moscow | Russian Federation | 119991 | |
| 45 | Clinical site | Moscow | Russian Federation | 121374 | |
| 46 | Clinical site | Moscow | Russian Federation | 129110 | |
| 47 | Clinical Site | Orenburg | Russian Federation | ||
| 48 | Clinical Site | Petrozavodsk | Russian Federation | ||
| 49 | Clinical site | Saratov | Russian Federation | 410039 | |
| 50 | Clinical Site | Saratov | Russian Federation | 410053 | |
| 51 | Clinical Site | Yaroslavl | Russian Federation | ||
| 52 | Clinical Site | Alcorcón | Spain | ||
| 53 | Clinical Site | Badalona | Spain | ||
| 54 | Clinical Site | Barcelona | Spain | 08025 | |
| 55 | Clinical site | Barcelona | Spain | 08036 | |
| 56 | Clinical Site | Barcelona | Spain | ||
| 57 | Clinical Site | Fuenlabrada | Spain | ||
| 58 | Clinical Site | L'Hospitalet De Llobregat | Spain | ||
| 59 | Clinical Site | Sevilla | Spain | 41010 | |
| 60 | Clinical Site | Sevilla | Spain | 41013 | |
| 61 | Clinical Site | Sevilla | Spain | 41014 | |
| 62 | Clinical Site | Göteborg | Sweden | ||
| 63 | Clinical Site | Stockholm | Sweden | ||
| 64 | Clinical Site | Uppsala | Sweden | ||
| 65 | Clinical Site | Saint Gallen | Switzerland | ||
| 66 | Clinical Site | Zuerich | Switzerland | ||
| 67 | Clinical Site | Aberdeen | United Kingdom | ||
| 68 | Clinical Site | Cambridge | United Kingdom | ||
| 69 | Clinical Site | Cardiff | United Kingdom | ||
| 70 | Clinical Site | Leicester | United Kingdom | ||
| 71 | Clinical Site | London | United Kingdom | NW3 2QG | |
| 72 | Clinical Site | London | United Kingdom | SE1 9RT | |
| 73 | Clinical Site | Portsmouth | United Kingdom | ||
| 74 | Clinical Site | Preston | United Kingdom | ||
| 75 | Clinical Site | Reading | United Kingdom | ||
| 76 | Clinical Site | Sheffield | United Kingdom |
Sponsors and Collaborators
- InflaRx GmbH
Investigators
- Study Director: Anja Pfaff, PhD, InflaRx GmbH
- Principal Investigator: Peter A. Merkel, MD, MPH, University of Pennsylvania
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
InflaRx GmbH
ClinicalTrials.gov Identifier:
NCT03895801
Other Study ID Numbers:
- IFX-1-P2.5
First Posted:
Mar 29, 2019
Last Update Posted:
Aug 25, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by InflaRx GmbH
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | IFX-1 + Placebo-GC | Placebo-IFX-1 + Standard Dose GC | IFX-1 + Reduced Dose GC |
|---|---|---|---|
| Arm/Group Description | IFX-1: 800 mg intravenously administered on Days 1, 4, and 8, and then every other week from Week 2 (Day 15) to Week 16; Placebo-Glucocorticoid (Placebo-GC): orally administered daily | Placebo-IFX-1: Placebo infusion intravenously administered on Days 1, 4, and 8, and then every other week from Week 2 (Day 15) to Week 16; Glucocorticoid (GC): starting dose of 60 mg daily orally administered, then tapered down | IFX-1: 800 mg intravenously administered on Days 1, 4, and 8, and then every other week from Week 2 (Day 15) to Week 16; Glucocorticoid (GC): starting dose of 30 mg daily orally administered, then tapered down |
| Period Title: Overall Study | |||
| STARTED | 18 | 24 | 15 |
| COMPLETED | 16 | 22 | 13 |
| NOT COMPLETED | 2 | 2 | 2 |
Baseline Characteristics
| Arm/Group Title | IFX-1 + Placebo-GC | Placebo-IFX-1 + Standard Dose GC | IFX-1 + Reduced Dose GC | Total |
|---|---|---|---|---|
| Arm/Group Description | IFX-1: intravenously administered; Placebo-Glucocorticoid (Placebo-GC): orally administered | Placebo-IFX-1: intravenously administered; Glucocorticoid (GC): orally administered | IFX-1: intravenously administered; Glucocorticoid (GC): orally administered | Total of all reporting groups |
| Overall Participants | 18 | 24 | 15 | 57 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
60.8
(11.4)
|
55.0
(12.3)
|
58.5
(14.0)
|
57.8
(12.6)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
6
33.3%
|
6
25%
|
5
33.3%
|
17
29.8%
|
| Male |
12
66.7%
|
18
75%
|
10
66.7%
|
40
70.2%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
1
5.6%
|
0
0%
|
0
0%
|
1
1.8%
|
| Not Hispanic or Latino |
17
94.4%
|
24
100%
|
15
100%
|
56
98.2%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| White |
18
100%
|
24
100%
|
15
100%
|
57
100%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| AAV disease type (Count of Participants) | ||||
| Granulomatosis with polyangiitis (GPA) |
10
55.6%
|
16
66.7%
|
11
73.3%
|
37
64.9%
|
| Microscopic polyangiitis (MPA) |
8
44.4%
|
8
33.3%
|
4
26.7%
|
20
35.1%
|
Outcome Measures
| Title | Percentage of Subjects Achieving Clinical Response |
|---|---|
| Description | 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. |
| Time Frame | Baseline, Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set |
| Arm/Group Title | IFX-1 + Placebo-GC | Placebo-IFX-1 + Standard Dose GC | IFX-1 + Reduced Dose GC |
|---|---|---|---|
| Arm/Group Description | IFX-1: intravenously administered; Placebo-Glucocorticoid (Placebo-GC): orally administered | Placebo-IFX-1: intravenously administered; Glucocorticoid (GC): orally administered | IFX-1: intravenously administered; Glucocorticoid (GC): orally administered |
| Measure Participants | 18 | 23 | 13 |
| Count of Participants [Participants] |
16
88.9%
|
22
91.7%
|
10
66.7%
|
| Title | Percentage of Subjects With Clinical Remission |
|---|---|
| Description | 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. |
| Time Frame | Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set |
| Arm/Group Title | IFX-1 + Placebo-GC | Placebo-IFX-1 + Standard Dose GC | IFX-1 + Reduced Dose GC |
|---|---|---|---|
| Arm/Group Description | IFX-1: intravenously administered; Placebo-Glucocorticoid (Placebo-GC): orally administered | Placebo-IFX-1: intravenously administered; Glucocorticoid (GC): orally administered | IFX-1: intravenously administered; Glucocorticoid (GC): orally administered |
| Measure Participants | 18 | 23 | 13 |
| Count of Participants [Participants] |
14
77.8%
|
20
83.3%
|
10
66.7%
|
| Title | Change From Baseline in BVASv3 Total Score |
|---|---|
| Description | 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. |
| Time Frame | Baseline, Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set |
| Arm/Group Title | IFX-1 + Placebo-GC | Placebo-IFX-1 + Standard Dose GC | IFX-1 + Reduced Dose GC |
|---|---|---|---|
| Arm/Group Description | IFX-1: intravenously administered; Placebo-Glucocorticoid (Placebo-GC): orally administered | Placebo-IFX-1: intravenously administered; Glucocorticoid (GC): orally administered | IFX-1: intravenously administered; Glucocorticoid (GC): orally administered |
| Measure Participants | 16 | 22 | 12 |
| Mean (Standard Deviation) [score on a scale] |
-13.8
(4.1)
|
-14.7
(5.9)
|
-16.6
(5.8)
|
| Title | Vasculitis Damage Index (VDI) |
|---|---|
| Description | 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. |
| Time Frame | Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set |
| Arm/Group Title | IFX-1 + Placebo-GC | Placebo-IFX-1 + Standard Dose GC | IFX-1 + Reduced Dose GC |
|---|---|---|---|
| Arm/Group Description | IFX-1: intravenously administered; Placebo-Glucocorticoid (Placebo-GC): orally administered | Placebo-IFX-1: intravenously administered; Glucocorticoid (GC): orally administered | IFX-1: intravenously administered; Glucocorticoid (GC): orally administered |
| Measure Participants | 16 | 22 | 12 |
| Mean (Standard Deviation) [score on a scale] |
1.0
(1.0)
|
1.5
(1.1)
|
1.9
(1.8)
|
| Title | Physician Global Assessment (PGA) |
|---|---|
| Description | Efficacy endpoint: Absolute values in PGA; Physician global assessment scale: 0 = Remission to 10 = Maximum activity; |
| Time Frame | Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set |
| Arm/Group Title | IFX-1 + Placebo-GC | Placebo-IFX-1 + Standard Dose GC | IFX-1 + Reduced Dose GC |
|---|---|---|---|
| Arm/Group Description | IFX-1: intravenously administered; Placebo-Glucocorticoid (Placebo-GC): orally administered | Placebo-IFX-1: intravenously administered; Glucocorticoid (GC): orally administered | IFX-1: intravenously administered; Glucocorticoid (GC): orally administered |
| Measure Participants | 16 | 22 | 12 |
| Mean (Standard Deviation) [score on a scale] |
0.4
(1.0)
|
0.1
(0.5)
|
0.7
(1.8)
|
| Title | Estimated Glomerular Filtration Rate |
|---|---|
| Description | 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) |
| Time Frame | Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set |
| Arm/Group Title | IFX-1 + Placebo-GC | Placebo-IFX-1 + Standard Dose GC | IFX-1 + Reduced Dose GC |
|---|---|---|---|
| Arm/Group Description | IFX-1: intravenously administered; Placebo-Glucocorticoid (Placebo-GC): orally administered | Placebo-IFX-1: intravenously administered; Glucocorticoid (GC): orally administered | IFX-1: intravenously administered; Glucocorticoid (GC): orally administered |
| Measure Participants | 16 | 22 | 12 |
| Mean (Standard Deviation) [mL/min/1.73 m²] |
50.2
(17.7)
|
57.0
(22.8)
|
51.2
(26.2)
|
| Title | Number and Percentage of Subjects Who Had a Treatment-emergent Adverse Event (TEAE) |
|---|---|
| Description | Safety endpoint: Number and percentage of subjects who had a treatment-emergent adverse event (TEAE) |
| Time Frame | Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Analysis Set |
| Arm/Group Title | IFX-1 + Placebo-GC | Placebo-IFX-1 + Standard Dose GC | IFX-1 + Reduced Dose GC |
|---|---|---|---|
| Arm/Group Description | IFX-1: intravenously administered; Placebo-Glucocorticoid (Placebo-GC): orally administered | Placebo-IFX-1: intravenously administered; Glucocorticoid (GC): orally administered | IFX-1: intravenously administered; Glucocorticoid (GC): orally administered |
| Measure Participants | 18 | 24 | 15 |
| Count of Participants [Participants] |
16
88.9%
|
24
100%
|
15
100%
|
| Title | Glucocorticoid Toxicity Index (GTI) |
|---|---|
| Description | 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. |
| Time Frame | Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Analysis Set (Data missing from 2 patients in IFX-1 + Placebo-GC group, from 2 patients in Placebo-IFX-1 + standard dose GC group, and from 3 patients in IFX-1 + reduced dose GC group) |
| Arm/Group Title | IFX-1 + Placebo-GC | Placebo-IFX-1 + Standard Dose GC | IFX-1 + Reduced Dose GC |
|---|---|---|---|
| Arm/Group Description | IFX-1: intravenously administered; Placebo-Glucocorticoid (Placebo-GC): orally administered | Placebo-IFX-1: intravenously administered; Glucocorticoid (GC): orally administered | IFX-1: intravenously administered; Glucocorticoid (GC): orally administered |
| Measure Participants | 16 | 22 | 12 |
| Mean (Standard Deviation) [score on a scale] |
0.8
(9.0)
|
44.9
(41.5)
|
26.1
(39.2)
|
| Title | IFX-1 Plasma Concentrations (Pre-dose) |
|---|---|
| Description | Pharmacokinetics endpoint: IFX-1 plasma concentrations assessed prior to study drug administration at corresponding visit. |
| Time Frame | Week 16 (pre-dose) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Analysis Set (Data missing from 5 patients in IFX-1 + Placebo-GC group, from 7 patients in Placebo-IFX-1 + standard dose GC group, and from 7 patients in IFX-1 + reduced dose GC group) |
| Arm/Group Title | IFX-1 + Placebo-GC | Placebo-IFX-1 + Standard Dose GC | IFX-1 + Reduced Dose GC |
|---|---|---|---|
| Arm/Group Description | IFX-1: intravenously administered; Placebo-Glucocorticoid (Placebo-GC): orally administered | Placebo-IFX-1: intravenously administered; Glucocorticoid (GC): orally administered | IFX-1: intravenously administered; Glucocorticoid (GC): orally administered |
| Measure Participants | 13 | 17 | 8 |
| Geometric Mean (Geometric Coefficient of Variation) [ng/mL] |
67077.19
(77.33)
|
47.80
(152.42)
|
52597.85
(118.15)
|
| Title | Plasma Concentrations of C5a |
|---|---|
| Description | Pharmacodynamics endpoint: Plasma concentrations of C5a |
| Time Frame | Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (Data missing from 4 patients in IFX-1 + Placebo-GC group, from 10 patients in Placebo-IFX-1 + standard dose GC group, and from 8 patients in IFX-1 + reduced dose GC group) |
| Arm/Group Title | IFX-1 + Placebo-GC | Placebo-IFX-1 + Standard Dose GC | IFX-1 + Reduced Dose GC |
|---|---|---|---|
| Arm/Group Description | IFX-1: intravenously administered; Placebo-Glucocorticoid (Placebo-GC): orally administered | Placebo-IFX-1: intravenously administered; Glucocorticoid (GC): orally administered | IFX-1: intravenously administered; Glucocorticoid (GC): orally administered |
| Measure Participants | 14 | 14 | 7 |
| Mean (Standard Deviation) [ng/mL] |
10.6816
(5.8505)
|
39.2822
(25.6249)
|
13.6320
(12.3040)
|
| Title | IFX-1 Blocking Activity 10 nM |
|---|---|
| Description | Pharmacodynamics endpoint: IFX-1 blocking activity 10 nM |
| Time Frame | Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (Data missing from 4 patients in IFX-1 + Placebo-GC group, and from 7 patients in IFX-1 + reduced dose GC group, IFX-1 blocking activity was not assessed for patients in Placebo-IFX-1 + standard dose GC group) |
| Arm/Group Title | IFX-1 + Placebo-GC | Placebo-IFX-1 + Standard Dose GC | IFX-1 + Reduced Dose GC |
|---|---|---|---|
| Arm/Group Description | IFX-1: intravenously administered; Placebo-Glucocorticoid (Placebo-GC): orally administered | Placebo-IFX-1: intravenously administered; Glucocorticoid (GC): orally administered | IFX-1: intravenously administered; Glucocorticoid (GC): orally administered |
| Measure Participants | 14 | 0 | 8 |
| Mean (Standard Deviation) [percentage of IFX-1 blocking activity] |
100.571
(2.651)
|
100.508
(10.051)
|
| Title | IFX-1 Blocking Activity 2.5 nM |
|---|---|
| Description | Pharmacodynamics endpoint: IFX-1 blocking activity 2.5 nM |
| Time Frame | Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (Data missing from 4 patients in IFX-1 + Placebo-GC group, and from 7 patients in IFX-1 + reduced dose GC group, IFX-1 blocking activity was not assessed for patients in Placebo-IFX-1 + standard dose GC group) |
| Arm/Group Title | IFX-1 + Placebo-GC | Placebo-IFX-1 + Standard Dose GC | IFX-1 + Reduced Dose GC |
|---|---|---|---|
| Arm/Group Description | IFX-1: intravenously administered; Placebo-Glucocorticoid (Placebo-GC): orally administered | Placebo-IFX-1: intravenously administered; Glucocorticoid (GC): orally administered | IFX-1: intravenously administered; Glucocorticoid (GC): orally administered |
| Measure Participants | 14 | 0 | 8 |
| Mean (Standard Deviation) [percentage of IFX-1 blocking activity] |
98.260
(16.731)
|
121.881
(59.979)
|
Adverse Events
| Time Frame | 24 weeks | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | IFX-1 + Placebo-GC | Placebo-IFX-1 + Standard Dose GC | IFX-1 + Reduced Dose GC | |||
| Arm/Group Description | IFX-1: intravenously administered Placebo-Glucocorticoid (Placebo-GC): orally administered | Placebo-IFX-1: intravenously administered Glucocorticoid (GC): orally administered | IFX-1: intravenously administered Glucocorticoid (GC): orally administered | |||
All Cause Mortality |
||||||
| IFX-1 + Placebo-GC | Placebo-IFX-1 + Standard Dose GC | IFX-1 + Reduced Dose GC | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/18 (5.6%) | 0/24 (0%) | 0/15 (0%) | |||
Serious Adverse Events |
||||||
| IFX-1 + Placebo-GC | Placebo-IFX-1 + Standard Dose GC | IFX-1 + Reduced Dose GC | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 5/18 (27.8%) | 4/24 (16.7%) | 3/15 (20%) | |||
| Blood and lymphatic system disorders | ||||||
| Thrombocytopenia | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Cardiac disorders | ||||||
| Acute myocardial infarction | 1/18 (5.6%) | 1 | 0/24 (0%) | 0 | 0/15 (0%) | 0 |
| Cardiac failure | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| General disorders | ||||||
| Condition aggravated | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Malaise | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Pyrexia | 0/18 (0%) | 0 | 0/24 (0%) | 0 | 1/15 (6.7%) | 1 |
| Immune system disorders | ||||||
| Anti-neutrophil cytoplasmic antibody positive vasculitis | 1/18 (5.6%) | 1 | 0/24 (0%) | 0 | 0/15 (0%) | 0 |
| Infections and infestations | ||||||
| Pneumocystis jirovecii pneumonia | 1/18 (5.6%) | 1 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Pulmonary sepsis | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Staphylococcal sepsis | 1/18 (5.6%) | 1 | 0/24 (0%) | 0 | 0/15 (0%) | 0 |
| Urinary tract infection | 0/18 (0%) | 0 | 0/24 (0%) | 0 | 1/15 (6.7%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Pulmonary embolism | 0/18 (0%) | 0 | 0/24 (0%) | 0 | 1/15 (6.7%) | 1 |
| Vascular disorders | ||||||
| Granulomatosis with polyangiitis | 1/18 (5.6%) | 1 | 0/24 (0%) | 0 | 0/15 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||
| IFX-1 + Placebo-GC | Placebo-IFX-1 + Standard Dose GC | IFX-1 + Reduced Dose GC | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 15/18 (83.3%) | 23/24 (95.8%) | 15/15 (100%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 2/18 (11.1%) | 2 | 0/24 (0%) | 0 | 2/15 (13.3%) | 2 |
| Lymphopenia | 0/18 (0%) | 0 | 4/24 (16.7%) | 4 | 0/15 (0%) | 0 |
| Leukopenia | 2/18 (11.1%) | 3 | 0/24 (0%) | 0 | 0/15 (0%) | 0 |
| Eosinophilia | 1/18 (5.6%) | 1 | 0/24 (0%) | 0 | 0/15 (0%) | 0 |
| Lymphadenopathy | 1/18 (5.6%) | 1 | 0/24 (0%) | 0 | 0/15 (0%) | 0 |
| Neutropenia | 1/18 (5.6%) | 1 | 0/24 (0%) | 0 | 0/15 (0%) | 0 |
| Cardiac disorders | ||||||
| Atrial fibrillation | 1/18 (5.6%) | 1 | 0/24 (0%) | 0 | 1/15 (6.7%) | 1 |
| Tachycardia | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 1/15 (6.7%) | 1 |
| Atrial thrombosis | 1/18 (5.6%) | 1 | 0/24 (0%) | 0 | 0/15 (0%) | 0 |
| Atrioventricular block first degree | 0/18 (0%) | 0 | 0/24 (0%) | 0 | 1/15 (6.7%) | 1 |
| Cardiac failure | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Diastolic dysfunction | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Left ventricular hypertrophy | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Sinus tachycardia | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Congenital, familial and genetic disorders | ||||||
| Dermoid cyst | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Ear and labyrinth disorders | ||||||
| Ear congestion | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Ear pain | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Endocrine disorders | ||||||
| Cushing's syndrome | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Eye disorders | ||||||
| Dry eye | 1/18 (5.6%) | 1 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Conjunctival haemorrhage | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Corneal erosion | 0/18 (0%) | 0 | 0/24 (0%) | 0 | 1/15 (6.7%) | 1 |
| Dacryoadenitis acquired | 0/18 (0%) | 0 | 0/24 (0%) | 0 | 1/15 (6.7%) | 1 |
| Eye pain | 0/18 (0%) | 0 | 1/24 (4.2%) | 2 | 0/15 (0%) | 0 |
| Vision blurred | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Visual impairment | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Gastrointestinal disorders | ||||||
| Constipation | 1/18 (5.6%) | 1 | 2/24 (8.3%) | 2 | 1/15 (6.7%) | 1 |
| Diarrhoea | 3/18 (16.7%) | 3 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Nausea | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 3/15 (20%) | 3 |
| Vomiting | 1/18 (5.6%) | 1 | 1/24 (4.2%) | 1 | 2/15 (13.3%) | 2 |
| Abdominal pain | 1/18 (5.6%) | 1 | 0/24 (0%) | 0 | 1/15 (6.7%) | 1 |
| Dyspepsia | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Flatulence | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Gastrointestinal disorder | 0/18 (0%) | 0 | 0/24 (0%) | 0 | 1/15 (6.7%) | 1 |
| Gastrooesophageal reflux disease | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Gingivitis ulcerative | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Glossodynia | 0/18 (0%) | 0 | 0/24 (0%) | 0 | 1/15 (6.7%) | 1 |
| Mouth ulceration | 0/18 (0%) | 0 | 0/24 (0%) | 0 | 1/15 (6.7%) | 1 |
| General disorders | ||||||
| Fatigue | 0/18 (0%) | 0 | 4/24 (16.7%) | 4 | 2/15 (13.3%) | 2 |
| Fat tissue increased | 1/18 (5.6%) | 1 | 4/24 (16.7%) | 5 | 0/15 (0%) | 0 |
| Adverse drug reaction | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 3/15 (20%) | 3 |
| Pyrexia | 1/18 (5.6%) | 1 | 2/24 (8.3%) | 2 | 1/15 (6.7%) | 1 |
| Oedema peripheral | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 2/15 (13.3%) | 2 |
| Chest pain | 0/18 (0%) | 0 | 2/24 (8.3%) | 2 | 0/15 (0%) | 0 |
| Condition aggravated | 1/18 (5.6%) | 1 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Feeling cold | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 1/15 (6.7%) | 1 |
| Chills | 0/18 (0%) | 0 | 1/24 (4.2%) | 2 | 0/15 (0%) | 0 |
| Feeling hot | 0/18 (0%) | 0 | 0/24 (0%) | 0 | 1/15 (6.7%) | 1 |
| Infusion site extravasation | 1/18 (5.6%) | 1 | 0/24 (0%) | 0 | 0/15 (0%) | 0 |
| Non-cardiac chest pain | 1/18 (5.6%) | 1 | 0/24 (0%) | 0 | 0/15 (0%) | 0 |
| Pain | 1/18 (5.6%) | 1 | 0/24 (0%) | 0 | 0/15 (0%) | 0 |
| Thirst | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Immune system disorders | ||||||
| Hypogammaglobulinaemia | 0/18 (0%) | 0 | 2/24 (8.3%) | 2 | 0/15 (0%) | 0 |
| Drug hypersensitivity | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Secondary immunodeficiency | 0/18 (0%) | 0 | 0/24 (0%) | 0 | 1/15 (6.7%) | 1 |
| Infections and infestations | ||||||
| Nasopharyngitis | 1/18 (5.6%) | 1 | 6/24 (25%) | 7 | 5/15 (33.3%) | 6 |
| Pneumonia | 0/18 (0%) | 0 | 3/24 (12.5%) | 3 | 0/15 (0%) | 0 |
| Urinary tract infection | 1/18 (5.6%) | 1 | 2/24 (8.3%) | 2 | 0/15 (0%) | 0 |
| Cystitis | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 1/15 (6.7%) | 1 |
| Upper respiratory tract infection | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 1/15 (6.7%) | 1 |
| Viral infection | 1/18 (5.6%) | 1 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Asymptomatic COVID-19 | 1/18 (5.6%) | 1 | 0/24 (0%) | 0 | 0/15 (0%) | 0 |
| Bacterial disease carrier | 0/18 (0%) | 0 | 0/24 (0%) | 0 | 1/15 (6.7%) | 1 |
| Candida infection | 0/18 (0%) | 0 | 0/24 (0%) | 0 | 1/15 (6.7%) | 1 |
| Conjunctivitis | 1/18 (5.6%) | 1 | 0/24 (0%) | 0 | 0/15 (0%) | 0 |
| Folliculitis | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Gastroenteritis | 0/18 (0%) | 0 | 0/24 (0%) | 0 | 1/15 (6.7%) | 1 |
| Helicobacter gastritis | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Influenza | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Oral candidiasis | 0/18 (0%) | 0 | 0/24 (0%) | 0 | 1/15 (6.7%) | 1 |
| Oropharyngeal candidiasis | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Pustule | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Sinusitis | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Viral rhinitis | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Vulvovaginal candidiasis | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||
| Skin laceration | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 2/15 (13.3%) | 2 |
| Arthropod bite | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Contusion | 0/18 (0%) | 0 | 0/24 (0%) | 0 | 1/15 (6.7%) | 1 |
| Epicondylitis | 1/18 (5.6%) | 2 | 0/24 (0%) | 0 | 0/15 (0%) | 0 |
| Fall | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Heavy exposure to ultraviolet light | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Skin abrasion | 0/18 (0%) | 0 | 0/24 (0%) | 0 | 1/15 (6.7%) | 2 |
| Spinal compression fracture | 1/18 (5.6%) | 1 | 0/24 (0%) | 0 | 0/15 (0%) | 0 |
| Sunburn | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Thermal burn | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Tooth fracture | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Traumatic haematoma | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Investigations | ||||||
| Weight increased | 1/18 (5.6%) | 1 | 5/24 (20.8%) | 5 | 0/15 (0%) | 0 |
| Alanine aminotransferase increased | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Blood creatinine increased | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Blood sodium increased | 0/18 (0%) | 0 | 0/24 (0%) | 0 | 1/15 (6.7%) | 1 |
| Cardiac murmur | 0/18 (0%) | 0 | 0/24 (0%) | 0 | 1/15 (6.7%) | 1 |
| Hepatic enzyme abnormal | 1/18 (5.6%) | 1 | 0/24 (0%) | 0 | 0/15 (0%) | 0 |
| Hepatic enzyme increased | 0/18 (0%) | 0 | 0/24 (0%) | 0 | 1/15 (6.7%) | 1 |
| Intraocular pressure increased | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Liver function test increased | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||
| Fluid retention | 3/18 (16.7%) | 4 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Hyperkalaemia | 1/18 (5.6%) | 1 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Hyperlipidaemia | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 1/15 (6.7%) | 1 |
| Hypocalcaemia | 2/18 (11.1%) | 2 | 0/24 (0%) | 0 | 0/15 (0%) | 0 |
| Increased appetite | 1/18 (5.6%) | 1 | 0/24 (0%) | 0 | 1/15 (6.7%) | 1 |
| Decreased appetite | 1/18 (5.6%) | 1 | 0/24 (0%) | 0 | 0/15 (0%) | 0 |
| Dyslipidaemia | 0/18 (0%) | 0 | 0/24 (0%) | 0 | 1/15 (6.7%) | 1 |
| Gout | 0/18 (0%) | 0 | 0/24 (0%) | 0 | 1/15 (6.7%) | 1 |
| Hypercalcaemia | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Hypercholesterolaemia | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Hyperglycaemia | 0/18 (0%) | 0 | 0/24 (0%) | 0 | 1/15 (6.7%) | 2 |
| Hypokalaemia | 0/18 (0%) | 0 | 1/24 (4.2%) | 2 | 0/15 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||
| Muscle spasms | 1/18 (5.6%) | 1 | 6/24 (25%) | 7 | 1/15 (6.7%) | 1 |
| Arthralgia | 3/18 (16.7%) | 4 | 1/24 (4.2%) | 1 | 3/15 (20%) | 4 |
| Myalgia | 2/18 (11.1%) | 2 | 1/24 (4.2%) | 1 | 2/15 (13.3%) | 2 |
| Back pain | 0/18 (0%) | 0 | 2/24 (8.3%) | 4 | 0/15 (0%) | 0 |
| Limb discomfort | 1/18 (5.6%) | 1 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Pain in extremity | 1/18 (5.6%) | 1 | 1/24 (4.2%) | 2 | 0/15 (0%) | 0 |
| Exostosis | 0/18 (0%) | 0 | 0/24 (0%) | 0 | 1/15 (6.7%) | 1 |
| Facet joint syndrome | 1/18 (5.6%) | 1 | 0/24 (0%) | 0 | 0/15 (0%) | 0 |
| Muscle atrophy | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Neck pain | 1/18 (5.6%) | 1 | 0/24 (0%) | 0 | 0/15 (0%) | 0 |
| Osteoporosis | 0/18 (0%) | 0 | 0/24 (0%) | 0 | 1/15 (6.7%) | 1 |
| Rhabdomyolysis | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Spondylolisthesis | 1/18 (5.6%) | 1 | 0/24 (0%) | 0 | 0/15 (0%) | 0 |
| Tendon discomfort | 0/18 (0%) | 0 | 0/24 (0%) | 0 | 1/15 (6.7%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Skin papilloma | 1/18 (5.6%) | 1 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Haemangioma | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Melanocytic naevus | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Nervous system disorders | ||||||
| Headache | 3/18 (16.7%) | 3 | 5/24 (20.8%) | 5 | 2/15 (13.3%) | 2 |
| Disturbance in attention | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 1/15 (6.7%) | 1 |
| Carotid arteriosclerosis | 0/18 (0%) | 0 | 0/24 (0%) | 0 | 1/15 (6.7%) | 1 |
| Dizziness | 1/18 (5.6%) | 1 | 0/24 (0%) | 0 | 0/15 (0%) | 0 |
| Hypoaesthesia | 1/18 (5.6%) | 1 | 0/24 (0%) | 0 | 0/15 (0%) | 0 |
| Memory impairment | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Paraesthesia | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Transient ischaemic attack | 0/18 (0%) | 0 | 0/24 (0%) | 0 | 1/15 (6.7%) | 1 |
| Tremor | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Psychiatric disorders | ||||||
| Sleep disorder | 1/18 (5.6%) | 1 | 4/24 (16.7%) | 4 | 1/15 (6.7%) | 1 |
| Insomnia | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 1/15 (6.7%) | 1 |
| Mood swings | 0/18 (0%) | 0 | 2/24 (8.3%) | 2 | 0/15 (0%) | 0 |
| Abnormal behaviour | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Agitation | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Anxiety | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Decreased interest | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Depressed mood | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Depression | 0/18 (0%) | 0 | 0/24 (0%) | 0 | 1/15 (6.7%) | 1 |
| Irritability | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Persistent depressive disorder | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Renal and urinary disorders | ||||||
| Nocturia | 2/18 (11.1%) | 2 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Acute kidney injury | 1/18 (5.6%) | 1 | 0/24 (0%) | 0 | 0/15 (0%) | 0 |
| Haematuria | 0/18 (0%) | 0 | 0/24 (0%) | 0 | 1/15 (6.7%) | 1 |
| Renal impairment | 0/18 (0%) | 0 | 0/24 (0%) | 0 | 1/15 (6.7%) | 1 |
| Reproductive system and breast disorders | ||||||
| Gynaecomastia | 1/18 (5.6%) | 1 | 0/24 (0%) | 0 | 0/15 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Dyspnoea | 1/18 (5.6%) | 1 | 2/24 (8.3%) | 2 | 0/15 (0%) | 0 |
| Bronchostenosis | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Dysphonia | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Dyspnoea exertional | 1/18 (5.6%) | 1 | 0/24 (0%) | 0 | 0/15 (0%) | 0 |
| Epistaxis | 1/18 (5.6%) | 1 | 0/24 (0%) | 0 | 0/15 (0%) | 0 |
| Nasal crusting | 0/18 (0%) | 0 | 0/24 (0%) | 0 | 1/15 (6.7%) | 1 |
| Oropharyngeal pain | 0/18 (0%) | 0 | 0/24 (0%) | 0 | 1/15 (6.7%) | 1 |
| Pulmonary embolism | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Pulmonary pain | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Stridor | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Wheezing | 0/18 (0%) | 0 | 0/24 (0%) | 0 | 1/15 (6.7%) | 1 |
| Skin and subcutaneous tissue disorders | ||||||
| Rash | 1/18 (5.6%) | 1 | 2/24 (8.3%) | 2 | 1/15 (6.7%) | 1 |
| Erythema | 0/18 (0%) | 0 | 2/24 (8.3%) | 3 | 0/15 (0%) | 0 |
| Acne | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Dermatitis | 0/18 (0%) | 0 | 1/24 (4.2%) | 2 | 0/15 (0%) | 0 |
| Dermatitis acneiform | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Eczema | 1/18 (5.6%) | 1 | 0/24 (0%) | 0 | 0/15 (0%) | 0 |
| Eczema asteatotic | 1/18 (5.6%) | 1 | 0/24 (0%) | 0 | 0/15 (0%) | 0 |
| Hand dermatitis | 1/18 (5.6%) | 1 | 0/24 (0%) | 0 | 0/15 (0%) | 0 |
| Night sweats | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Seborrhoea | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Skin lesion | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Urticaria | 1/18 (5.6%) | 1 | 0/24 (0%) | 0 | 0/15 (0%) | 0 |
| Vascular disorders | ||||||
| Hypertension | 2/18 (11.1%) | 2 | 6/24 (25%) | 7 | 2/15 (13.3%) | 2 |
| Haematoma | 1/18 (5.6%) | 1 | 2/24 (8.3%) | 2 | 0/15 (0%) | 0 |
| Deep vein thrombosis | 0/18 (0%) | 0 | 0/24 (0%) | 0 | 2/15 (13.3%) | 2 |
| Cyanosis | 0/18 (0%) | 0 | 0/24 (0%) | 0 | 1/15 (6.7%) | 2 |
| Granulomatosis with polyangiitis | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Haemorrhage | 0/18 (0%) | 0 | 0/24 (0%) | 0 | 1/15 (6.7%) | 1 |
| Hot flush | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
| Vasculitis | 0/18 (0%) | 0 | 0/24 (0%) | 0 | 1/15 (6.7%) | 1 |
| White coat hypertension | 0/18 (0%) | 0 | 1/24 (4.2%) | 1 | 0/15 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Prof. Niels C. Riedemann |
|---|---|
| Organization | InflaRx GmbH |
| Phone | +49 3641-508-180 |
| niels.Riedemann@inflarx.de |
Responsible Party:
InflaRx GmbH
ClinicalTrials.gov Identifier:
NCT03895801
Other Study ID Numbers:
- IFX-1-P2.5
First Posted:
Mar 29, 2019
Last Update Posted:
Aug 25, 2022
Last Verified:
Aug 1, 2022