Clinical trials: Toll-Like Receptors
Delayed Graft Function
Placebo-Controlled Study to Evaluate the Safety and Efficacy of OPN-305 in Preventing Delayed Renal Graft Function
When a patient receives a kidney transplant particularly if the kidney is from an older donor or one who has had the kidney removed after their heart has stopped, there is a risk that the newly transplanted kidney may not…
- Trial name
- NCT01794663
- Testing
- OPN-305
- Where
- 50 sites in United States, Austria and 9 more
- Volunteers
- 252 people
- Sponsor
- Opsona Therapeutics Ltd.
Ulcerative Colitis
The Efficacy and Safety of Cobitolimod in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis
The purpose of the study is to evaluate the efficacy of cobitolimod treatment compared to placebo in inducing clinical remission, in participants with moderate to severe active left-sided UC and to evaluate the efficacy of…
- Trial name
- CONCLUDE (NCT04985968)
- Testing
- Cobitolimod 250 mg, Cobitolimod 500 mg
- Where
- 203 sites in United States, Australia and 26 more
- Volunteers
- 171 people
- Sponsor
- InDex Pharmaceuticals
Neoplasms
A Study of DSP-0509 in Patients With Advanced Solid Tumors to Determine the Safety and the Pharmacokinetic Profile
This is a multi-center, Phase 1 / 2 clinical study for patients with advanced solid tumors. The study consists of 2 treatment arms - a monotherapy arm and a combination arm.
- Trial name
- NCT03416335
- Testing
- DSP-0509, DSP-0509, Pembrolizumab
- Where
- 5 sites in United States
- Volunteers
- 36 people
- Sponsor
- Sumitomo Pharma America, Inc.
Chronic Hepatitis C
Safety Study of SD-101 (a Novel C Type Toll-like Receptor 9 (TLR9) Agonist) for the Treatment of Chronic Hepatitis C Virus (HCV) Infection
To determine safety, tolerability, and preliminary efficacy of escalating doses of SD-101 alone and SD-101 plus ribavirin in subjects with chronic hepatitis C and no prior therapy.
- Trial name
- NCT00823862
- Testing
- SD-101, ribavirin
- Where
- 5 sites in Poland
- Volunteers
- 34 people
- Sponsor
- Dynavax Technologies Corporation
Hepatitis C Virus
Multiple Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04878691
To assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of PF-04878691.
- Trial name
- NCT00810758
- Testing
- PF-04878691 3mg, PF-04878691 6mg, PF-04878691 9mg
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy Volunteers
First in Human Study of an Anti-Toll-like Receptor 4 (TLR4) Monoclonal Antibody (NI-0101) in Adult Healthy Volunteers
The purpose of this study is to determine the safety, tolerability and distribution and elimination of a novel therapeutic drug when administered to Healthy Volunteers.
- Trial name
- NI-0101-01 (NCT01808469)
- Testing
- Monoclonal antibody
- Where
- Netherlands
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Light Chain Bioscience - Novimmune SA
Advanced Non Small Cell Lung Cancer
Phase 1b DV281 With an Anti-PD-1 Inhibitor in NSCLC
This open-label, multicenter, dose-escalation and expansion trial is designed to evaluate the safety and preliminary efficacy of inhaled DV281 in combination with nivolumabfor the treatment of NSCLC and to select a recommended…
- Trial name
- NCT03326752
- Testing
- DV281, Breath Actuated Nebulizer, DV281 (RP2D)
- Where
- 6 sites in United States
- Volunteers
- 26 people
- Sponsor
- Dynavax Technologies Corporation
Bladder Cancer
PF-07225570 Alone or in Combination With an Anti-PD-1 Antibody in Recurrent Non-muscle Invasive Bladder Cancer (NMIBC)
The primary objective of this study is to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of PF-07225570 alone or in combination with an anti-PD-1 antibody in participants with recurrent…
- Trial name
- NCT05259397
- Testing
- PF-07225570, sasanlimab
- Where
- 4 sites in United States, Poland
- Sponsor
- Pfizer
Prostate Cancer
Study of STM-416p Administered to Patients Undergoing Radical Prostatectomy
A Study of STM-416p Administered Intraoperatively to Patients Undergoing Radical Prostatectomy
- Trial name
- NCT06450106
- Testing
- STM-416p
- Where
- 4 sites in United States, Australia
- Volunteers
- 18 people
- Sponsor
- SURGE Therapeutics
Systematic Lupus Erythematosus, Cutaneous Lupus Erythematosus
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)
The purpose of this global, multicenter, Phase 3 study is to evaluate the efficacy and safety of enpatoran over 24 weeks in participants with active cutaneous manifestations of lupus erythematosus with or without systemic…
- Trial name
- NCT07355218
- Testing
- Enpatoran, Standard of care (SoC)
- Where
- 57 sites in United States, Australia and 15 more
- Volunteers
- 202 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Asthma
A Safety and Efficacy Study of Intranasal GSK2245035 in Adults With Allergic Asthma
GSK2245035 belongs to a novel class of agonist drugs targeted at toll like receptors (TLR). T-helper cell 2 (Th2) driven inflammation is a key patho-physiological mechanism in allergic asthma.
- Trial name
- NCT03707678
- Testing
- GSK2245035, FP-DPI, Albuterol/Salbutamol
- Sponsor
- GlaxoSmithKline
Hepatitis B, HBV
A Study Evaluating GS-9620 in Treatment Naive Subjects With Chronic Hepatitis B
Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). Dose escalation or repetition will be governed by pre-specified safety and activity rules.
- Trial name
- NCT01590641
- Testing
- Single Ascending Dose (SAD) Cohorts GS-9620, Multiple Ascending Dose (MAD) Cohorts
- Where
- 23 sites in United States, Australia and 3 more
- Volunteers
- 49 people
- Sponsor
- Gilead Sciences
Systemic Lupus Erythematosus
The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)
The purpose of the study is to evaluate the long term safety and efficacy of orally administered M5049 in participants with subacute cutaneous lupus erythematosus (SCLE), discoid lupus erythematosus (DLE) and/or systemic lupus…
- Trial name
- NCT05540327
- Testing
- M5049 low dose, M5049 medium dose, M5049 high dose
- Where
- 122 sites in United States, Argentina and 20 more
- Volunteers
- 381 people
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Non-muscle-invasive Bladder Cancer
A Study of STM-416 Administered to Patients Undergoing TURBT for Recurrent Bladder Cancer
This is a first-in-human (FIH), Phase 1/2a, multi center, open-label, single treatment, dose escalation and expansion study designed to determine the safety and tolerability of STM-416 in patients with bladder cancer.
- Trial name
- NCT05710848
- Testing
- STM-416
- Where
- 20 sites in United States
- Volunteers
- 75 people
- Sponsor
- SURGE Therapeutics
Plaque Psoriasis
A 12-week Dose-Ranging Trial in Patients With Moderate to Severe Plaque Psoriasis
IMO 8400 is a second-generation oligonucleotide antagonist of endosomal Toll-like receptors (TLR) 7, TLR8 and TLR9. These TLR react to complexes of exogenous nucleic acids (as might be encountered during infection) and endogenous…
- Trial name
- 8400-201 (NCT01899729)
- Testing
- IMO-8400 Regimen 1, IMO-8400 Regimen 2, IMO-8400 Regimen 3
- Where
- Netherlands
- Volunteers
- 46 people
- Sponsor
- Idera Pharmaceuticals, Inc.
Mild Asthma and Allergic Rhinitis
To Investigate the Safety, Pharmacodynamics and Effect on Allergic Reactivity of the Toll-like Receptor 7 (TLR7) Agonist GSK2245035 in Subjects With Respiratory Allergies
The purpose of this study is to examine the safety and effects on the immune system of treatment with GSK2245035 in subjects who suffer from nasal symptoms caused by an allergy to pollen or perennial allergen, with or without…
- Trial name
- NCT01788813
- Testing
- GSK2245035
- Where
- Canada
- Volunteers
- 42 people
- Sponsor
- GlaxoSmithKline
Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)
A Long-Term Extension (LTE) Study Of Enpatoran In Cutaneous Manifestations Of Lupus With Or Without Systemic Disease [Elowen-LTE]
The purpose of this study is to evaluate the long-term safety and efficacy of orally administered enpatoran in participants with cutaneous manifestations of lupus erythematosus who have completed the Elowen-1 (MS504908_0001)…
- Trial name
- NCT07840287
- Testing
- Enpatoran
- Where
- 2 sites in United States, Germany
- Volunteers
- 404 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Rheumatoid Arthritis
Study of an Anti-TLR4 mAb in Rheumatoid Arthritis
This is a Phase 2, PoC, randomized, placebo-controlled, double blind, international multicentre study to explore the effect of a new antibody to treat patients with Rheumatoid Arthritis
- Trial name
- NCT03241108
- Testing
- NI-0101
- Where
- 19 sites in Bosnia and Herzegovina, Bulgaria and 5 more
- Volunteers
- 90 people
- Sponsor
- Light Chain Bioscience - Novimmune SA
Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease
The purpose of this global, multicenter, Phase 3 study is to evaluate the efficacy and safety of enpatoran over 24 weeks in participants with active cutaneous manifestations of lupus erythematosus with or without systemic…
- Trial name
- ELOWEN-1 (NCT07332481)
- Testing
- Enpatoran, Standard of care (SoC)
- Where
- 60 sites in United States, Australia and 14 more
- Volunteers
- 202 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Dermatomyositis, Polymyositis
Study of M5049 in DM and PM Participants (NEPTUNIA)
The purpose of this study is to evaluate the efficacy and safety of orally administered M5049 in idiopathic inflammatory myopathies, specifically dermatomyositis (DM) and polymyositis (PM) participants for 24 weeks.
- Trial name
- NCT05650567
- Testing
- M5049 dose
- Where
- 31 sites in United States, Czechia and 5 more
- Volunteers
- 20 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.