Clinical trials: Proof of Concept
Acne Vulgaris
Study of Oral Zileuton in the Treatment of Moderate to Severe Facial Acne Vulgaris
Tissue inflammation is a major component of the acne disease process. Leukotriene B4 (LTB4) is thought to be a major player in the development of tissue inflammation. Synthesis of LTB4 is controlled by the enzyme 5-lipoxygenase.
- Trial name
- NCT00098358
- Testing
- Zileuton
- Where
- 12 sites in United States
- Volunteers
- 90 people
- Sponsor
- Critical Therapeutics
Arthritis, Rheumatoid
A Study of Effectiveness and Safety of CNTO 136 in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
The purpose of this study is to evaluate the effectiveness and safety of subcutaneous (under the skin) administration of anti-interleukin-6 monoclonal antibody (CNTO 136) in reducing signs and symptoms of participants with active…
- Trial name
- NCT00718718
- Testing
- CNTO 136 100 mg, CNTO 136 50 mg, CNTO 136 25 mg
- Where
- 38 sites in United States, Hungary and 5 more
- Volunteers
- 187 people
- Sponsor
- Centocor, Inc.
Metastatic Colorectal Cancer
Sotevtamab (AB-16B5) Combined With FOLFOX as Neoadjuvant Treatment Prior to Resection of Colorectal Cancer Liver Metastasis
This Phase II study will recruit 17 colorectal cancer patients with liver-dominant metastases. All recruited patients will receive Sotevtamab at a dose of 800 mg once weekly for 6 cycles combined with FOLFOX once every 2 weeks…
- Trial name
- EGIA-003 (NCT06225843)
- Testing
- Sotevtamab, FOLFOX
- Where
- Canada
- Volunteers
- 17 people
- Sponsor
- Alethia Biotherapeutics
Septic Shock
Treatment of Patients With Early Septic Shock and Bio-Adrenomedullin(ADM) Concentration > 70 pg/ml With ADRECIZUMAB
This is a double-blind, placebo-controlled, randomized, multicenter proof of concept and dose-finding phase II study using two doses of ADRECIZUMAB in patients with early septic shock and a bio-ADM plasma concentration at…
- Trial name
- AdrenOSS-2 (NCT03085758)
- Testing
- Adrecizumab
- Where
- 30 sites in Belgium, France and 2 more
- Volunteers
- 301 people
- Sponsor
- Adrenomed AG
Dyslipidemia
Efficacy and Safety of PRC-4016 in Subjects With Mixed Dyslipidemia
The objective of this study is To evaluate the efficacy of PRC-4016 by assessment of the percentage change in blood lipids and lipoprotein parameter from baseline after 12 weeks of treatment To evaluate the safety of PRC-4016 as…
- Trial name
- NCT01972178
- Testing
- PRC-4016, Statins
- Where
- 29 sites in United States
- Volunteers
- 113 people
- Sponsor
- Pronova BioPharma
HIV-1-infection
The HIV Functional Cure Potential of UB-421 in ART Stabilized HIV-1 Patients
This is a Phase II, randomized, open-label, multi-center, active-controlled study to assess the safety, tolerability, and efficacy of UB-421 administered as an add-on to the standard ART in ART-treated HIV-1 subjects with stably…
- Trial name
- HIV-1 (NCT04404049)
- Testing
- UB-421(25 mg/kg) Q2W, UB-421(25 mg/kg) Q4W
- Volunteers
- 39 people
- Sponsor
- UBP Greater China (Shanghai) Co., Ltd
Sleep Apnea, Obstructive
A Trial to Learn More About How Well BAY2586116 Works and How Safe it is in Participants With Moderate to Severe Obstructive Sleep Apnea
Researchers are looking for a better way to treat people with obstructive sleep apnea (OSA). In people with OSA, the upper airways can narrow or close repetitively while sleeping.
- Trial name
- SPRAY-SMART (NCT04713826)
- Testing
- BAY2586116
- Where
- 3 sites in Germany, Switzerland
- Volunteers
- 93 people
- Sponsor
- Bayer
Wound Heal, Mouth; Wound
Impact of Daily Use of The Emanate Tray Adjunct to Full Mouth Debridement Compared to Full Mouth Debridement Alone
The study is a 56-day (8-week), randomized, controlled, examiner-blinded, parallel-design study of patients with existing Stage II or Stage III periodontitis.
- Conditions
- Wound Heal, Mouth; Wound, Periodontal Inflammation
- Trial name
- NCT05282615
- Testing
- Emanate Tray
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Emanate Biomedical Inc.
Systemic Lupus Erythematosus
Efficacy and Safety of Frexalimab (SAR441344) in the Treatment of Systemic Lupus Erythematosus
This is a multinational, randomized, placebo-controlled, parallel treatment, Phase 2, double-blind, 2 arm study evaluating the efficacy and safety of SAR441344 in comparison with placebo in the treatment of participants aged 18…
- Trial name
- APATURA (NCT05039840)
- Testing
- SAR441344 IV, SAR441344 SC
- Where
- 73 sites in United States, Argentina and 14 more
- Volunteers
- 109 people
- Sponsor
- Sanofi
Relapsing-Remitting Multiple Sclerosis
A Proof of Concept Study to Evaluate the Effectiveness of Tysabri in Relapsing Remitting Multiple Sclerosis (RRMS) Patient Bladder Function
The primary objective of the study was to measure the change in bladder function as measured by Urogenital Distress Inventory (UDI)-6 compared to baseline over 6 months of Tysabri treatment.
- Trial name
- TRUST (NCT00818038)
- Testing
- BG0002 (natalizumab)
- Volunteers
- 30 people
- Sponsor
- Biogen
Degenerative Disc Disease
Phase 2a Study on Allogeneic Osteoblastic Cells Implantation in Lumbar Spinal Fusion
Among existing surgical techniques, spinal fusion is considered as the gold standard to treat a broad spectrum of degenerative spine disorders, including spondylolisthesis and scoliosis, with regard to pain reduction and…
- Trial name
- NCT02205138
- Testing
- ALLOB® cells with ceramic scaffold
- Where
- 8 sites in Belgium
- Volunteers
- 38 people
- Sponsor
- Bone Therapeutics S.A
Acute Myeloid Leukemia
A Study of Siremadlin in Combination With Venetoclax Plus Azacitidine in Adult Participants With Acute Myeloid Leukemia (AML) Who Are Ineligible for Chemotherapy.
A study of siremadlin in combination with venetoclax plus azacitidine in adult participants with AML who are ineligible for chemotherapy.
- Trial name
- NCT05155709
- Testing
- siremadlin, venetoclax, azacitidine
- Where
- 10 sites in United States, Hong Kong and 5 more
- Volunteers
- 14 people
- Sponsor
- Novartis Pharmaceuticals
COVID-19 Drug Treatment
Ivermectin Effect on SARS-CoV-2 Replication in Patients With COVID-19
In the context of COVID-19 pandemic, a report on ivermectin suppression of SARS-CoV-2 viral replication in cell cultures has been published, and the use of this medication seems to be potentially useful for the therapy.
- Trial name
- NCT04381884
- Testing
- IVERMECTIN (IVER P®) arm will receive IVM 600 µg / kg once daily plus standard care. CONTROL arm will receive standard care.
- Where
- 3 sites in Argentina
- Volunteers
- 45 people
- Sponsor
- Laboratorio Elea Phoenix S.A.
Underactive Bladder
A Study of ASP8302 in Participants With Underactive Bladder
The study objectives of this study are to evaluate the efficacy of ASP8302 compared with placebo in participants with underactive bladder (UAB), to investigate the safety and tolerability of ASP8302 compared with placebo in…
- Trial name
- NCT03702777
- Testing
- ASP8302
- Where
- 29 sites in Germany, Japan and 4 more
- Volunteers
- 135 people
- Sponsor
- Astellas Pharma Europe B.V.
Sedation in the ICU
A Study of Remimazolam Tosilate for Prolonged Sedation in the ICU
The purpose of this study is to evaluate the efficacy and safety of Remimazolam Tosilate for Injection for prolonged sedation(≥72h) during mechanical ventilation in the ICU.
- Trial name
- NCT05913336
- Testing
- Remimazolam Tosilate
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Ulcerative Colitis
A Phase 1b Proof-of-concept Trial Exploring the Effects of FE 999322 and FE 999324 in Adults With Mild to Moderate Ulcerative Colitis
To explore the safety of FE 999322 (microbiota suspension) and FE 999324 (microbiota capsule) versus placebo in subjects with active mild to moderate ulcerative colitis (UC).
- Trial name
- NCT06260267
- Testing
- Microbiota suspension, Microbiota capsule
- Where
- 10 sites in United States
- Sponsor
- Ferring Pharmaceuticals
Exudative Age-Related Macular Degeneration
LHA510 Proof-of-Concept Study as a Maintenance Therapy for Patients With Wet Age-Related Macular Degeneration
The purpose of this study is to evaluate the efficacy of 84 successive days of topically administered LHA510 compared to vehicle in reducing the number of patients requiring intravitreal (IVT) anti-vascular endothelial growth…
- Trial name
- NCT02355028
- Testing
- LHA510 ophthalmic suspension, LHA510 vehicle, Ranibizumab ophthalmic solution
- Where
- United States
- Volunteers
- 136 people
- Sponsor
- Alcon, a Novartis Company
Cluster Headache
Effect of Ketamine Intranasal Spray in Treatment of Chronic Cluster Headache
Ketamine has been used clinically IV in a very safe manner by a very small number of clinicians, to treat migraines and CH, and various other rarer pain disorders, including mixed headache and neuropathic pain clinical syndromes.
- Trial name
- NCT04179266
- Testing
- Ketamine
- Where
- Denmark
- Volunteers
- 23 people
- Sponsor
- CCH Pharmaceuticals
Osteoarthritis of the Knee
Dose Finding Study of Bone Morphogenetic Protein 7 (BMP-7) in Subjects With Osteoarthritis (OA) of the Knee
The objectives of the study are to evaluate the safety and efficacy of intraarticular BMP-7 for the treatment of osteoarthritis of the knee.
- Trial name
- NCT01111045
- Testing
- Bone morphogenetic protein 7
- Where
- 25 sites in United States
- Volunteers
- 355 people
- Sponsor
- Stryker Biotech
Covid19, COVID-19 Lower Respiratory Infection
In-patient COVID-19 Study of Intranasal Foralumab
This is a Phase 2, randomized, placebo-controlled, double-blind, proof-of-concept study of intranasal foralumab in hospitalized subjects with severe COVID-19 and pulmonary inflammation.
- Conditions
- Covid19, COVID-19 Lower Respiratory Infection, COVID-19 Respiratory Infection
- Trial name
- NCT04983446
- Testing
- Foralumab
- Sponsor
- Tiziana Life Sciences LTD