Clinical trials: PFS
Carcinoma, Non-Small-Cell Lung
A Study of Durvalumab as Consolidation Therapy in Non-Small Cell Lung Cancer Patients
This is a Phase III, randomised, double-blind, placebo-controlled, multicentre study assessing the efficacy and safety of durvalumab compared with placebo, as consolidation therapy in patients with locally advanced, unresectable…
- Trial name
- PACIFIC-5 (NCT03706690)
- Testing
- Durvalumab
- Where
- 87 sites in China, Hong Kong and 8 more
- Volunteers
- 407 people
- Sponsor
- AstraZeneca
Healthy Volunteers
A Study to Compare the Pharmacokinetics (PK) of Single Subcutaneous (SC) Injections of Vedolizumab Administered in Prefilled Syringe (PFS) Versus (vs) Prefilled Syringe in Needle Safety Device (PFS+NSD) in Healthy Participants
The purpose of this study is to compare the PK of single dose of vedolizumab SC 108 milligram (mg) administered as PFS vs investigational device.
- Trial name
- NCT03949621
- Testing
- Vedolizumab SC
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Takeda
Multiple Sclerosis
A 12 Week Randomized Open Label Parallel Group Multicenter Study to Evaluate Bioequivalence of 20 mg Subcutaneous Ofatumumab Injected by Pre-filled Syringe or Autoinjector in Adult RMS Patients
The primary purpose of this study is to demonstrate pharmacokinetic bioequivalence of ofatumumab injected by Pre-filled Syringe (PFS) versus Auto-Injector (AI) devices and thereby establish a bridge between the ongoing Phase 3…
- Trial name
- NCT03560739
- Testing
- ofatumumab with PRF, ofatumumab with AI
- Where
- 41 sites in United States, Austria and 7 more
- Volunteers
- 284 people
- Sponsor
- Novartis Pharmaceuticals
Carcinoma, Non-Small-Cell Lung
Progression Free Survival (PFS) Using Erlotinib for Non-Small-Cell Lung Cancer (NSCLC) in Chinese Population
This trial is an extension to ENSURE, a study of erlotinib versus gemcitabine/cisplatin combination chemotherapy as the first-line treatment for patients with non-small-cell lung cancer (NSCLC) with mutations in the tyrosine…
- Trial name
- NCT02000531
- Testing
- Erlotinib, Chemotherapy
- Where
- 11 sites in China
- Volunteers
- 45 people
- Sponsor
- Hoffmann-La Roche
Epithelial Ovarian Cancer
A Study to Examine Olaparib Maintenance Retreatment in Patients With Epithelial Ovarian Cancer.
The OReO study will be a Phase IIIb, randomised, double-blind, placebo-controlled, multicentre study to assess the efficacy and tolerability of Olaparib retreatment, versus matching placebo, in non-mucinous epithelial ovarian…
- Trial name
- OReO (NCT03106987)
- Testing
- Active Comparator: Olaparib tablets
- Where
- 82 sites in Belgium, Canada and 9 more
- Volunteers
- 220 people
- Sponsor
- AstraZeneca
Healthy
A Study to Assess the Pharmacokinetic Comparability of Guselkumab (CNTO1959) When Delivered by 2 Different Devices and as 2 Formulations in Healthy Participants
The purpose of this study is to evaluate the pharmacokinetic (what the body does to the medication) comparability of guselkumab in lyophilized and liquid formulations.
- Trial name
- NCT01866007
- Testing
- Guselkumab (lyophilized formulation), Guselkumab (liquid formulation with PFS-U), Guselkumab (liquid formulation with PFS FID)
- Where
- 3 sites in United States
- Volunteers
- 141 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Squamous Cell Carcinoma of the Head and Neck
Phase III Open Label Study of MEDI 4736 With/Without Tremelimumab Versus Standard of Care (SOC) in Recurrent/Metastatic Head and Neck Cancer
This is a randomized, open-label, multi-center, 3-arm, global Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination or MEDI4736 monotherapy versus SoC (EXTREME regimen) in the treatment of…
- Trial name
- KESTREL (NCT02551159)
- Testing
- MEDI4736, Tremelimumab, MEDI4736+Tremelimumab
- Where
- 197 sites in United States, Austria and 21 more
- Volunteers
- 823 people
- Sponsor
- AstraZeneca
Healthy Volunteer
A Bioequivalence Study of Subcutaneous (SC) Lebrikizumab Administered by Needle and Syringe or by Prefilled Syringe With Needle Safety Device (PFS-NSD)
This study will assess the bioequivalence in healthy participants between a high-concentration formulation of lebrikizumab withdrawn from a vial and administered SC as a single injection by a needle and syringe, and a…
- Trial name
- NCT02486809
- Testing
- Lebrikizumab
- Where
- 4 sites in United States
- Volunteers
- 176 people, healthy volunteers welcome
- Sponsor
- Genentech, Inc.
Rheumatoid Arthritis, Polyarticular Juvenile Idiopathic Arthritis
Comparison of PK and Tolerability of MSB11022 Administered by AI or PFS
The primary objective of this study is to demonstrate equivalence of the pharmacokinetic (PK) profile of MSB11022 administered by either an auto-injector (AI) or a pre-filled syringe (PFS) as single subcutaneous (s.c.) injection…
- Conditions
- Rheumatoid Arthritis, Polyarticular Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis
- Trial name
- NCT04018599
- Testing
- 40 mg MSB11022
- Where
- 2 sites in United States
- Volunteers
- 216 people, healthy volunteers welcome
- Sponsor
- Fresenius Kabi SwissBioSim GmbH
Graves' Disease, Graves Disease
A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease
The main purpose of this study is to look at how efgartigimod affects thyroid function in adults with Graves' Disease (GD). The study will also check whether efgartigimod is safe and well tolerated.
- Trial name
- VitaliThy (NCT07570316)
- Testing
- Efgartigimod PH20 SC
- Where
- 35 sites in United States, Georgia and 1 more
- Volunteers
- 230 people
- Sponsor
- argenx
Phase 1
PK, Safety and Tolerability Study of AVT02 (Adalimumab) Pre-filled Syringe (PFS) vs, AVT02 Autoinjector (AI)
This study has been designed as a multicentre, randomised, open label study of AVT02 in healthy adult subjects. The study will assess the PK, safety and tolerability of AVT02 in Pre-Filled Syringe compared to AVT02 in…
- Trial name
- NCT03983876
- Testing
- Adalimumab
- Where
- 2 sites in New Zealand
- Volunteers
- 207 people, healthy volunteers welcome
- Sponsor
- Alvotech Swiss AG
Diabetic Macular Edema (DME), Neovascular Age-Related Macular Degeneration (nAMD)
Study to Evaluate an 8 mg Aflibercept (EYLEA®) Prefilled Syringe (PFS)
Regeneron Pharmaceuticals developed a single-dose pre-filled syringe (PFS) to deliver 8 mg aflibercept. The PFS is a convenient device that contains the study medication that will be injected in your study eye.
- Trial name
- NCT05989126
- Testing
- aflibercept 8 mg PFS
- Where
- 2 sites in United States
- Volunteers
- 35 people
- Sponsor
- Regeneron Pharmaceuticals
Spondylitis, Ankylosing
Extension in AS: Sustainability of Benefits, Safety and Tolerability
This 3-year extension study aims at making available the treatment with secukinumab in prefilled syringes (PFS) to patients with ankylosing spondylitis who took part in phase III study CAIN457F2305, defined as "core study", as…
- Trial name
- MEASURE 1 ext (NCT01863732)
- Testing
- Secukinumab
- Where
- 56 sites in United States, Belgium and 12 more
- Volunteers
- 274 people
- Sponsor
- Novartis Pharmaceuticals
Crohn's Disease
An Observational Study to Assess Participant-Reported Real-World Experience of Risankizumab On-body Injector (OBI) for the Treatment of Crohn's Disease in Adult Participants in the United Kingdom (UK)
Crohn's Disease (CD) is a chronic condition that causes inflammation of the gastrointestinal tract or gut. This study will assess real-world, adult participant experience of self-injection with the risankizumab OBI.
- Trial name
- COMMODUS (NCT06126146)
- Where
- 5 sites in United Kingdom
- Volunteers
- 53 people
- Sponsor
- AbbVie
Carcinoma, Non-Small-Cell Lung
Cilengitide and Cetuximab in Combination With Platinum-based Chemotherapy as First-line Treatment for Subjects With Advanced Non Small Cell Lung Cancer (NSCLC)
Primary objective of the study's Safety run-in: To determine the maximum tolerated dose (MTD) of cilengitide in combination with cetuximab, and platinum-based chemotherapy (cisplatin/vinorelbine or cisplatin/gemcitabine).
- Trial name
- CERTO (NCT00842712)
- Testing
- Cilengitide, Cetuximab, Cisplatin
- Where
- 44 sites in Belgium, Czechia and 6 more
- Volunteers
- 232 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Healthy Volunteers
A Study to Compare Pharmacokinetics (PK) of Etrolizumab Administered Subcutaneously by a Prefilled Syringe With Needle Safety Device (PFS-NSD) or an Auto-injector (AI)
This is a randomized, 2-part, 2-arm, open-label, parallel-group, multi-center study to compare the PK of etrolizumab administered subcutaneously by an AI (test device) or a PFS-NSD (reference device) in healthy participants.
- Trial name
- NCT02996019
- Testing
- Etrolizumab, Auto-Injector (AI), Prefilled Syringe With Needle Safety Device (PFS-NSD)
- Where
- 4 sites in United States
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Genentech, Inc.
Moderate to Severe Chronic Plaque Psoriasis
This is Comparative Study in Normal Healthy Subjects to Evaluate Pharmacokinetics, Safety, Tolerability of Bmab 1200 -Autoinjector (AI) After Single Subcutaneous Injection (45 mg) in Comparison With Bmab 1200 -Prefilled Syringe (PFS).
This is an open-label, 2-arm parallel-group study in normal healthy subjects to evaluate pharmacokinetics, safety, tolerability of Bmab 1200 -autoinjector (AI) after single subcutaneous injection (45 mg) in comparison with Bmab…
- Trial name
- NCT06738277
- Testing
- Bmab 1200 (Biosimilar Ustekinumab)
- Where
- India
- Volunteers
- 186 people, healthy volunteers welcome
- Sponsor
- Biocon Biologics UK Ltd
Healthy Volunteers
A Pilot Study to Compare the Pharmacokinetics (PK) of Single Subcutaneous (SC) Injections of Vedolizumab Administered in Prefilled Syringe (PFS) Versus (vs) Prefilled Syringe in Needle Safety Device (PFS+NSD) in Healthy Participants
The purpose of this study is to compare the PK of single dose of vedolizumab SC 108 milligram (mg) administered as PFS vs investigational device.
- Trial name
- NCT03948581
- Testing
- Vedolizumab SC
- Where
- United States
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Takeda
Non-Squamous Non-Small Cell Lung Cancer
An Observational Study on Patients With Non-Squamous NSCLC Who Reached A Long PFS After Avastin (Bevacizumab)-Based First-Line Therapy
This retrospective observational study will analyse demographic, clinical and treatment-related data of patients with non-squamous non-small cell lung cancer (NSCLC) who had reached >/= 9 months of progression-free survival after…
- Trial name
- NCT01343914
- Where
- 33 sites in Spain
- Volunteers
- 118 people
- Sponsor
- Hoffmann-La Roche
Healthy Male Subjects
A Study to Compare the Auto-injector and Pre-filled Syringe of CT-P52 in Healthy Male Subjects
This is phase 1 study to Compare the Pharmacokinetics, Safety and Immunogenicity of the Auto-injector and Pre-filled syringe of CT-P52 in Healthy Male Subjects.
- Trial name
- NCT07367958
- Testing
- CT-P52
- Where
- South Korea
- Volunteers
- 218 people, healthy volunteers welcome
- Sponsor
- Celltrion