Sprachauswahl

Forschung und Entwicklung

Klinische Studien

Die klinischen Studien sind in der Entwicklung von Arzneimitteln der zentrale Schritt. Hier finden Sie eine Darstellung aller laufenden klinischen Studien von Biotest.

Immunologie

Titel

Indikation

Status

 
Tregalizumab (Studie 986) Rheumatoide Arthritis Studie beendet

A 24-week Phase IIb, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of Tregalizumab (BT061) in Combination With Methotrexate in the Treatment of Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Alone, Followed by a 24-week Extension Phase: T Cell REgulating Arthritis Trial 2b (TREAT 2b)

Link Clinicaltrial.gov
 
Tregalizumab (Studie 979) Rheumatoide Arthritis Studie beendet

A Multi-center, Double-blind, Randomized, Placebo-controlled, Dose-finding Study in Patients With Active Rheumatoid Arthritis Incompletely Controlled on Stable MTX Doses to Investigate Efficacy and Safety of SC BT061

Link clinicaltrials.gov
 
Tregalizumab (Studie 971) Rheumatoide Arthritis Studie beendet

A randomized, placebo-controlled, double-blind, dose escalation study to evaluate the efficacy, safety and tolerability of the study drug BT971 in patients with rheumatoid arthritis

Link clinicaltrialsregister.eu
 
Tregalizumab (Studie 962) Rheumatoide Arthritis Studie beendet

A randomised, placebo-controlled, double-blind, dose escalation study to evaluate the efficacy, safety, and tolerability of the study drug BT962 (humanised CD4 monoclonal antibody BT061 or placebo) in patients with chronic rheumatoid arthritis

 
Tregalizumab (Studie 973) Plaque Psoriasis Studie beendet

A Randomized, Placebo-controlled, Double-blind, Multicentre, Multiple Dose, Cohort Study With Escalating Doses to Evaluate the Safety and Efficacy of the Humanized Monoclonal Antibody BT061 Administered to Patients With Moderate to Severe Chronic Plaque Psoriasis

Link clinicaltrials.gov
 
Tregalizumab (Studie 967) Plaque Psoriasis Studie beendet

A randomised placebo-controlled double-blind dose escalation study to evaluate the efficacy, safety and pharmacokinetic properties of the humanised CD4 monoclonal antibody BT061 in patients with chronic plaque psoriasis

 
Tregalizumab (Studie 985) Gesunde Probanden Studie beendet

A prospective, open-label, randomized, monocenter, phase I study to investigate pharmacokinetic and pharmacodynamic properties of single SC doses of the humanized monoclonal antibody BT061

 
Tregalizumab (Studie 961) Gesunde Probanden Studie beendet

A prospective open-label single-dose study to investigate the safety and tolerability of low doses of the humanised CD4 monoclonal antibody BT061 in healthy volunteers

 
Cytotect (Studie 963) CMV Prophylaxe in der Schwangerschaft Rekrutierung abgeschlossen

Prävention der Übertragung von humanem Cytomegalievirus (HCMV) von der Mutter auf den Fetus durch die Gabe von Virus spezifischem Hyperimmunglobulin bei schwangeren Frauen mit primärer HCMV Infektion

Link clinicaltrialsregister.eu
 
BT-063 (Studie 977) Systemischer Lupus Erythematodes Studie beendet

A prospective, open-label, mono-centre study to investigate safety, tolerability, pharmacokinetic and immunological properties of single IV doses of the humanised anti-IL-10 monoclonal antibody BT063

 
BT-063 (Studie 990) Systemischer Lupus Erythematodes Studie läuft

 

Hämatologie

Titel

Indikation

Status

 
Indatuximab Ravtansine* (Studie 989) Solide Tumore Studie läuft

An open-label, twostage Phase I/IIa dose escalation study of BT062 in metastatic triple receptor-negative breast cancer and in metastatic transitional cell carcinoma of the urinary bladder

Link clinicaltrialsregister.eu
 
Indatuximab Ravtansine (Studie 969) Multiples Myelom Studie beendet

Safety and Dose Determining Study of BT062 in Patients With Relapsed or Refractory Multiple Myeloma

 
Indatuximab Ravtansine (Studie 975) Multiples Myelom Studie beendet

Safety and Dose Determining Multi-dose Study of BT062 in Patients With Relapsed or Refractory Multiple Myeloma

 
Indatuximab Ravtansine (Studie 983) Multiples Myelom Studie läuft

BT062 in Combination With Lenalidomide/Dexamethasone in Patients With Multiple Myeloma

Link clinicaltrials.gov
 

Intensivmedizin

Fibrinogen (Studie 984) Angeborener Fibrinogenmangel Studie läuft

A prospective, open-label, uncontrolled, single dose phase I/II study investigating pharmacokinetic properties, efficacy, safety, and tolerability of BT524 (fibrinogen concentrate from human plasma) in patients with congenital fibrinogen deficiency

Link clinicaltrials.gov   IgM Concentrate (Studie 970) Gesunde Probanden Studie beendet

A prospective, randomised, placebo-controlled, and single-blind phase I study investigating safety, tolerability, and pharmacokinetic properties of IgM Concentrate BT086 in healthy subjects

  Trimodulin (Studie 982) Schwere ambulant erworbene Lungenentzündung Studie beendet

A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group, Adaptive Group-sequential Phase II Study, to Determine the Efficacy and Safety of BT086 as an Adjunctive Treatment i Severe Community Acquired Pneumonia (sCAP)

Link clinicaltrials.gov