Research and development

Clinical trials

Clinical trials are the central step in drug development. Here you will find a list of all of Biotest’s current clinical trials.

Clinical immunology

Title

Indication

Status

 
Tregalizumab (Study 986) Rheumatoid arthritis Study completed

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 (Study 979) Rheumatoid arthritis Study completed

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 (Study 971) Rheumatoid arthritis Study completed

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 (Study 962) Rheumatoid arthritis Study completed

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 (Study 973) Plaque psoriasis Study completed

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 (Study 967) Plaque psoriasis Study completed

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 (Study 985) Healthy volunteers Study completed

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 (Study 961) Healthy volunteers Study completed

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 70 (Study 963) Congenital CMV infection prophylaxis Recruitment completed

Congenital CMV infection prophylaxis

Link clinicaltrialsregister.eu
 
BT-063 (Study 977) Systemic lupus erythematosus Study completed

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

 

Haematology

Title

Indication

Status

 
Indatuximab Ravtansine* (Study 989) Solid tumors Study ongoing

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 (Study 969) Multiple myeloma Study completed

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

 
Indatuximab Ravtansine (Study 975) Multiple myeloma Study completed

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

 
Indatuximab Ravtansine (Study 983) Multiple myeloma Study ongoing

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

Link clinicaltrials.gov
 

Intensive care medicine

Title

Indication

Status

 
Fibrinogen (Study 995) Congenital fibrinogen deficiency Study ongoing

A randomized, active-controlled, multicenter, phase III study investigating efficacy and safety of intra-operative use of BT524 (human fibrinogen concentrate) in subjects undergoing major spine surgery (AdFIrst).

Clinicaltrialsregister.eu
 
Fibrinogen (Study 984) Congenital fibrinogen deficiency Study ongoing

A prospective, open-label, uncontrolled, single dose phase I/III 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 (Study 970) Healthy volunteers Study completed

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 (Study 982) Severe community acquired pneumonia Study completed

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 in Severe Community Acquired Pneumonia (sCAP)

Link clinicaltrials.gov