Clinical trials: Biologic
Solid Tumor, Non Small Cell Lung Cancer
GEN-001 (Live Biotherapeutic Product) and Avelumab Combination Study for Patients With Solid Tumors Who Have Progressed on Anti-PD-(L)1 Therapy
This is a phase I/Ib, first-in-human (FIH), open-label, dose escalation and dose expansion study to evaluate the safety and tolerability, biological and clinical activities of GEN-001 in patients with locally advanced or…
- Conditions
- Solid Tumor, Non Small Cell Lung Cancer, Squamous Cell Carcinoma of Head and Neck, Urothelial Carcinoma
- Trial name
- NCT04601402
- Testing
- GEN-001, Avelumab
- Where
- 3 sites in United States
- Volunteers
- 11 people
- Sponsor
- Genome & Company
Prostate Cancer
PROvenge Treatment and Early Cancer Treatment
The PROTECT-PROvenge Treatment and Early Cancer Treatment trial was a Phase III trial for patients with hormone sensitive prostate cancer. The study was conducted at over 15 participating centers throughout the US.
- Trial name
- PROTECT (NCT00779402)
- Testing
- Control, Sipuleucel-T
- Where
- 18 sites in United States
- Volunteers
- 176 people
- Sponsor
- Dendreon
Healthy
Biopharmaceutical Study of Glyco pMDI With or Without Charcoal Block vs IV Bolus in Healthy Volunteers
The purpose of this study is to investigate the pharmacokinetics, the absolute bioavailability and the lung bioavailability of inhaled Glyco pMDI.
- Trial name
- Gly1 (NCT01176851)
- Testing
- Glycopyrrolate
- Where
- United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Hepatitis B
Immunogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine (2 Doses), and of Engerix™-B (3 Doses) in Healthy Adults
This study is undertaken to assess the immune response and safety profile of 4 lots of the novel adjuvanted hepatitis B vaccine that were formulated following different processes, with Engerix™-B as the control vaccine
- Trial name
- NCT00697853
- Testing
- Engerix™-B, HBV-MPL vaccine 208129
- Where
- Belgium
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Immune Thrombocytopenia (ITP), ITP
A Phase 1b/2a Study of Budoprutug in Subjects With Immune Thrombocytopenia (ITP)
The main objective is to assess the safety and tolerability of budoprutug in adults with ITP. Pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy will also be assessed.
- Conditions
- Immune Thrombocytopenia (ITP), ITP, Biologics, Monoclonal
- Trial name
- NCT07043946
- Testing
- Budoprutug
- Where
- 20 sites in Bulgaria, Greece and 3 more
- Volunteers
- 24 people
- Sponsor
- Climb Bio, Inc.
Huntington Disease
Safety and Tolerability Study With VY-HTT01, in Adults With Early Manifesting Huntington's Disease
This is the first clinical study of VY-HTT01, a gene therapy for early-stage Huntington's Disease (HD) patients. The primary goal of this trial is to evaluate the safety and tolerability of VY-HTT01.
- Trial name
- NCT04885114
- Testing
- Intraparenchymal rAAV1 - (mi)RNA HTT
- Sponsor
- Voyager Therapeutics
Measles, Varicella
Immunogenicity & Safety Study of GSK Biologicals' Combined Measles-mumps-rubella-varicella Vaccine 208136
This Phase 3b study is being conducted for the purpose of registration of the GSK208136 vaccine in Korea.
- Conditions
- Measles, Varicella, Mumps, Rubella
- Trial name
- NCT00751348
- Testing
- PriorixTM, VarilrixTM, Priorix-Tetra®
- Where
- 13 sites in South Korea
- Volunteers
- 475 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
HIV Infections
The Safety and Effectiveness of (+)-Calanolide A in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
The purpose of this study is to see if it is safe and effective to give calanolide A to HIV-infected adults who have not used anti-HIV drugs in the past.
- Trial name
- NCT00005120
- Testing
- Calanolide A
- Where
- 7 sites in United States
- Volunteers
- 16 people
- Sponsor
- Sarawak MediChem Pharmaceuticals
Diabetic Retinopathy
A Study of BI 765128 in Patients With an Eye Condition Called Diabetic Macular Ischemia Who Have Received Laser Treatment
This study is open to adults with diabetic macular ischemia who have received laser treatment. The main purpose of this study is to find out whether people with diabetic macular ischemia can tolerate a medicine called BI 765128.
- Trial name
- PARTRIDGE (NCT04919499)
- Testing
- BI 765128
- Where
- 25 sites in United States, Australia and 4 more
- Volunteers
- 46 people
- Sponsor
- Boehringer Ingelheim
Influenza, Influenza Vaccines
Safety & Immunogenicity of an Alternative Immunization Schedule of GSK Bio's Pandemic Influenza Vaccine (GSK1119711A)
The aim of the study is to assess the safety \& immunogenicity of a pandemic influenza vaccine administered at 2 different time points. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
- Trial name
- NCT00430521
- Testing
- Pandemic influenza vaccine (GSK1119711A)-formulation 1, Pandemic influenza vaccine (GSK1119711A)-formulation 2
- Where
- 10 sites in Germany
- Volunteers
- 512 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Haemophilus Influenzae Type b, Neisseria Meningitidis
Study in Toddlers to Demonstrate Non-inferiority of GSK Biologicals' Hib-MenC & to Evaluate Persistence up to 5 Years.
The purpose of the primary phase of the study is to demonstrate the non-inferiority of a single dose of GSK Biologicals' Haemophilus influenzae type b and meningococcal C (Hib-MenC) conjugate vaccine when given in the second year…
- Trial name
- NCT00326118
- Testing
- Haemophilus influenzae type b and meningococcal serogroup C (vaccine), Priorix™, Hiberix™
- Where
- 7 sites in Australia
- Volunteers
- 433 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Dermatitis Atopic
A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor
This is a parallel group, Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, 3-arm study for treatment of participants diagnosed with moderate-to-severe AD on background TCS who have had inadequate…
- Trial name
- AQUA (NCT06241118)
- Testing
- Amlitelimab, Topical corticosteroids, Topical tacrolimus or pimecrolimus
- Where
- 154 sites in United States, Argentina and 20 more
- Volunteers
- 464 people
- Sponsor
- Sanofi
Sickle Cell Disease
Safety, Pharmacokinetic, and Pharmacodynamic Study of NKTT120 in Adult Patients With Stable Sickle Cell Disease (SCD)
The purpose of this study is to determine the safety, pharmacokinetics, and pharmacodynamics of NKTT120 in adult patients with stable sickle cell disease.
- Trial name
- NCT01783691
- Testing
- NKTT120
- Where
- 6 sites in United States
- Volunteers
- 21 people
- Sponsor
- NKT Therapeutics
Asthma
A Study to Compare Severe Asthma Patients Who Start Biologics and Who do Not Start (PROSPECT)
Objectives in this study is to compare the change of lung function after 24 months from baseline between the two groups; one is the patient group who decided to start biologics treatment, and another is the patient group who…
- Trial name
- NCT04808518
- Where
- 28 sites in Japan
- Volunteers
- 74 people
- Sponsor
- AstraZeneca
Haemophilus Influenzae Type b, Neisseria Meningitidis
Long-term Persistence Study to Assess a Booster Dose of GSK Biologicals' Hib-MenC
This protocol posting deals with objectives \& outcome measures of the extension phase at Months 18, 30, 42, 54 and 66 post booster.
- Trial name
- NCT00322335
- Testing
- Haemophilus influenzae type b- and meningococcal (vaccine), Infanrix™ penta, Infanrix™ hexa
- Where
- 12 sites in Spain
- Volunteers
- 230 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria, Malaria Vaccines
A Study Assessing the Safety, Efficacy, and Impact of GlaxoSmithKline Biologicals' RTS, S/AS01E Malaria Vaccine in Young Children Across Sub-Saharan Africa
The RTS, S/AS01E vaccine was developed to protect children in sub-Saharan Africa from malaria as part of routine immunization programs. This study aims to check the vaccine's safety after it has been introduced.
- Trial name
- EPI-MAL-003 (NCT03855995)
- Testing
- Whole blood sample
- Where
- 6 sites in Ghana, Kenya and 1 more
- Volunteers
- 77,953 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Psoriatic Arthritis
A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (DMARD)
This study includes two periods. The main objective of Period 1 is to compare the efficacy of upadacitinib 15 mg once daily (QD) and 30 mg QD versus placebo and versus adalimumab (Humira®) in participants with moderately to…
- Trial name
- SELECT - PsA 1 (NCT03104400)
- Testing
- Adalimumab, Upadacitinib
- Where
- 345 sites in United States, Argentina and 44 more
- Volunteers
- 1,705 people
- Sponsor
- AbbVie
Advanced Solid Tumors
A Modified Phase I Study of NGR-hTNF in Advanced Solid Tumors
The main objective of the trial is to explore the safety and biological activity of NGR-hTNF. The safety will be established by clinical and laboratory assessment.
- Trial name
- NCT00419328
- Testing
- NGR-hTNF
- Where
- Italy
- Volunteers
- 16 people
- Sponsor
- AGC Biologics S.p.A.
Renal Cell Carcinoma
A Rollover Protocol for Subjects Previously Treated With AGS-003
The purpose of this study is to evaluate clinical response to AGS-003 alone or in combination with sunitinib therapy.
- Trial name
- NCT01482949
- Testing
- AGS-003
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Argos Therapeutics
Healthy
Study of Belimumab Administered Subcutaneously to Healthy Subjects
The purpose of this study is to measure the amount of belimumab in the blood when given as an injection under the skin (subcutaneously; SC) and to evaluate the safety and tolerability of multiple injections under the skin in…
- Trial name
- NCT01583530
- Testing
- Single Dose Group: Belimumab IV 240 mg, Single Dose Group: Belimumab SC 2 x 120 mg, Single Dose Group: Belimumab SC 1 x 240 mg
- Where
- 4 sites in United States
- Volunteers
- 118 people, healthy volunteers welcome
- Sponsor
- Human Genome Sciences Inc.