8 completed, 4 recruiting, 4 terminated. 14 Phase 2, 2 Phase 3, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 14 | Completed 7, Recruiting 4, Terminated 3 |
| Phase 3 | 2 | Completed 1, Terminated 1 |
| Phase 1 | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort C: Bevacizumab Cohort C: bevacizumab, Cohort C: placebo - Acute Respiratory Distress Syndrome (ARDS), ARDS | Phase 2 | Recruiting | PPD Development, LP | 200 | 2025-10-28 | 2026-07-31 |
| JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort A: Vilobelimab Cohort A: vilobelimab, Cohort A: placebo - Acute Respiratory Distress Syndrome (ARDS), ARDS | Phase 2 | Recruiting | PPD Development, LP | 200 | 2025-06-21 | 2026-07-31 |
| JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS (Master Record) Cohort A: vilobelimab, Cohort A: placebo, Cohort B: paridiprubart - Acute Respiratory Distress Syndrome (ARDS), ARDS | Phase 2 | Recruiting | PPD Development, LP | 600 | 2025-06-10 | 2026-07-31 |
| JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort B: Paridiprubart Cohort B: paridiprubart, Cohort B: placebo - Acute Respiratory Distress Syndrome (ARDS), ARDS | Phase 2 | Recruiting | PPD Development, LP | 200 | 2025-06-10 | 2026-07-31 |
| Evaluate Safety and Pharmacokinetics of INF904 in Subjects With Moderate to Severe Chronic Spontaneous Urticaria or Hidradenitis Suppurativa CSU lower dose treatment, CSU high dose treatment, CSU non responders IgE - high dose treatment - Chronic Urticaria, Idiopathic, Hidradenitis | Phase 2 | Terminated | InflaRx GmbH | 73 | 2025-01-02 | 2026-02-03 |
| Phase III Trial to Investigate Efficacy and Safety of Vilobelimab in Ulcerative Pyoderma Gangrenosum vilobelimab, Placebo - Pyoderma Gangrenosum | Phase 3 | Terminated | InflaRx GmbH | 54 | 2023-11-01 | 2025-11-04 |
| Non-comparative Study of IFX-1 Alone or IFX-1+Pembrolizumab in Patients With Locally Advanced or Metastatic cSCC. Vilobelimab, Vilobelimab + pembrolizumab combination therapy - SCC - Squamous Cell Carcinoma of Skin | Phase 2 | Terminated | InflaRx GmbH | 30 | 2021-03-31 | 2025-02-11 |
| Randomized, Controlled Study of IFX-1 in Patients With Severe COVID-19 Pneumonia IFX-1 + BSC, BSC, IFX-1 + SOC - Severe COVID-19 Pneumonia | Phase 2 / Phase 3 | Completed | InflaRx GmbH | 399 | 2020-03-31 | 2023-06-05 |
| Exploratory Study of IFX-1 in Patients With Pyoderma Gangrenosum vilobelimab - Pyoderma Gangrenosum | Phase 2 | Completed | InflaRx GmbH | 19 | 2019-05-16 | 2023-09-14 |
| Study of IFX-1 to Replace Steroids in Patients With Granulomatosis With Polyangiitis and Microscopic Polyangiitis. IFX-1, Placebo-IFX-1, Glucocorticoid (GC) - Granulomatosis With Polyangiitis (GPA), Microscopic Polyangiitis (MPA) | Phase 2 | Completed | InflaRx GmbH | 57 | 2019-04-03 | 2022-08-25 |
| Safety and Efficacy Study of IFX-1 in add-on to Standard of Care in GPA and MPA IFX-1 low dose, IFX-1 high dose, Placebo - Granulomatosis With Polyangiitis (GPA), Microscopic Polyangiitis (MPA) | Phase 2 | Terminated | InflaRx GmbH | 20 | 2018-10-15 | 2022-05-26 |
| Efficacy and Safety Study of IFX-1 in Patients With Moderate to Severe Hidradenitis Suppurativa (HS) IFX-1, Placebo - Hidradenitis Suppurativa (HS) | Phase 2 | Completed | InflaRx GmbH | 179 | 2018-02-26 | 2021-04-08 |
| Studying Complement Inhibition in Patients With Moderate to Severe Hidradenitis Suppurativa IFX-1 - Hidradenitis Suppurativa | Phase 2 | Completed | InflaRx GmbH | 12 | 2016-12-01 | 2017-09-19 |
| Studying Complement Inhibition in Complex Cardiac Surgery IFX-1, Placebo - Systemic Inflammatory Response Syndrome, C.Surgical Procedure; Cardiac | Phase 2 | Completed | InflaRx GmbH | 116 | 2016-05-01 | 2017-02-15 |
| Studying Complement Inhibition in Early, Newly Developing Septic Organ Dysfunction CaCP29, Placebo - Severe Sepsis, Septic Shock | Phase 2 | Completed | InflaRx GmbH | 72 | 2014-04-01 | 2016-04-25 |
| Clinical Assessment of Safety and Tolerability of the New Monoclonal Humanized Antibody CaCP29 CaCP29, a humanized monoclonal antibody - Drug Safety | Phase 1 | Completed | InflaRx GmbH | 26 | 2011-03-01 | 2012-01-13 |
Acute Lung Injury (4) · Respiratory Distress Syndrome (4) · Hidradenitis Suppurativa (3) · Inflammation (3) · Granulomatosis with Polyangiitis (2) · Microscopic Polyangiitis (2) · Pyoderma Gangrenosum (2) · Sepsis (2) · Systemic Inflammatory Response Syndrome (2) · Chronic Urticaria (1) · Hidradenitis (1) · Neoplasm Metastasis (1) · Pathologic Processes (1) · Shock, Septic (1) · Skin Diseases (1)
vilobelimab (10) · Glucocorticoids (1) · Prednisone (1) · Standard of Care (1) · Therapeutics (1) · pembrolizumab (1)
United States (10) · Germany (9) · France (5) · Belgium (4) · Poland (4) · Canada (3) · Greece (3) · Netherlands (3) · Spain (3) · Bulgaria (2) · Italy (2) · Russia (2) · Switzerland (2) · Australia (1) · Brazil (1)
Peter A. Merkel, MD, MPH (2) · A Vlaar, MD, PhD (1) · Alex GO Loayza, Prof, MD (1) · Anja Pfaff, PhD (1) · Grit Andersen, MD (1) · Korinna Pilz, MD, MS (1) · Michael Bauer, Prof. Dr. (1) · Othmar Zenker, CMO (1) · Prof. Dr. D. Schadendorf, MD (1) · Prof. Niels C. Riedemann, M.D., Ph.D. (1) · Torsten Doenst, Prof. Dr. (1)
PMID 34252397, PMID 33015643, PMID 33164993, PMID 34473343, PMID 35029045, PMID 36087611, PMID 37332066, PMID 38943192, PMID 40028879, PMID 41081529
2015 (1)