Clinical trials: Proof of Concept
Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Proof-of-concept Study for SAR445088 in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Primary Objectives: Part A: Efficacy of SAR445088 across three subpopulations of CIDP patients: standard of care (SOC)-Treated, SOC-Refractory and SOC-Naive Part B:Long-term safety and tolerability of SAR445088 in CIDP Secondary…
- Trial name
- NCT04658472
- Testing
- SAR445088 (IV), SAR445088 (SC)
- Where
- 32 sites in United States, Canada and 8 more
- Volunteers
- 98 people
- Sponsor
- Bioverativ, a Sanofi company
Scars
Juvista in the Non-surgical Improvement of Existing Scars
Renovo, a Biopharmaceutical company involved in the development of drugs to improve the appearance of scars and enhance wound healing, are proposing to carry out research in improving the appearance of existing scars that are 2-6…
- Trial name
- NCT00821457
- Testing
- Juvista
- Where
- United Kingdom
- Volunteers
- 40 people
- Sponsor
- Renovo
Diabetic Macular Edema
Ranibizumab "Treat and Extend" in Diabetic Macular Edma
This study is designed to explore a more individualized treatment regime based on achievement of disease stability to define a personal optimal treatment interval with ranibizumab in patients with visual impairment due to…
- Trial name
- OPTIMAL (NCT01297569)
- Testing
- Ranibizumab
- Where
- Norway
- Volunteers
- 7 people
- Sponsor
- Novartis Pharmaceuticals
Hyperparathyroidism, Secondary, Kidney Failure, Chronic
A Phase 2 Study of an Oral Vitamin D Compound (DP001) in Secondary Hyperparathyroidism in Patients on Hemodialysis
The goal of this study is to test a new vitamin D compound for its ability to reduce parathyroid hormone levels in patients who are on hemodialysis.
- Trial name
- 2MD-7H-2B (NCT01922843)
- Testing
- DP001 softgel capsules
- Where
- 14 sites in United States
- Volunteers
- 62 people
- Sponsor
- Deltanoid Pharmaceuticals
Obesity, Insulin Resistance
The Primary Objective of This Study is to Determine Whether MICARDIS® Improves Insulin Sensitivity in Overweight or Obese, Non-diabetic, Normotensive Subjects
The primary objective of this study is to determine whether MICARDIS® improves insulin sensitivity in overweight or obese, non-diabetic, normotensive subjects.
- Trial name
- NCT00146289
- Testing
- MICARDIS® (telmisartan)
- Where
- 17 sites in United States, Canada and 3 more
- Volunteers
- 138 people
- Sponsor
- Boehringer Ingelheim
Pain, Acute
Dose Finding Study of STR-324
This study aims to evaluate the analgesic effect and the safety of 4 doses of STR-324 administered as an infusion, with or without initial bolus, to patients suffering from post-operative pain.
- Trial name
- NCT04582786
- Testing
- Morphine, Morphine HCl, STR-324
- Where
- Netherlands
- Volunteers
- 118 people
- Sponsor
- Alaxia SAS
Nonalcoholic Steatohepatitis
Safety, Tolerability, and Efficacy of Monotherapy and Combination Regimens in Participants With Nonalcoholic Steatohepatitis (NASH)
The primary objective of this study is to evaluate the safety and tolerability of study drug(s) in participants with nonalcoholic steatohepatitis (NASH).
- Trial name
- NCT03987074
- Testing
- Semaglutide, Firsocostat, Cilofexor
- Where
- 18 sites in United States
- Volunteers
- 109 people
- Sponsor
- Gilead Sciences
Ulcerative Colitis
Open Label Study to Assess Safety, PK and Explore Efficacy of OPRX-106 in Patients With Active Mild to Moderate Ulcerative Colitis
This is a proof of concept, randomized, open label, 2-arm study of OPRX-106 in subjects with active mild to moderate ulcerative colitis.
- Trial name
- NCT02768974
- Testing
- OPRX-106
- Where
- 7 sites in Israel
- Volunteers
- 20 people
- Sponsor
- Protalix
Heavy Uterine Bleeding, Uterine Fibroids
Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids
The purpose of this proof-of-concept study is to assess the safety and effectiveness of elagolix versus placebo to reduce uterine bleeding associated with uterine fibroids, and to reduce fibroid volume and uterine volume in…
- Trial name
- NCT01441635
- Testing
- Elagolix, Estradiol/Norethindrone acetate (E2/NETA), Estradiol
- Volunteers
- 271 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Healthy Volunteers, Atopic Dermatitis
A Study Evaluating the Safety and Efficacy of Topical BPR277 for the Treatment of Atopic Dermatitis and Netherton Syndrome
The study is divided in 3 parts, starting with the safety assessment of BPR277 ointment in Healthy volunteers (Part 1). If found to be well tolerated in Part 1, BPR277 ointment will be assessed in two different patients groups to…
- Conditions
- Healthy Volunteers, Atopic Dermatitis, Netherton Syndrome
- Trial name
- 3 (NCT01428297)
- Testing
- BPR277 ointment (controlled application), BPR277 ointment, BPR277
- Where
- 4 sites in United States, Netherlands
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Relapse Remitting Multiple Sclerosis
A Study to Assess the Effect of a Single Infusion of VAY736 on Disease Activity in Patients With Relapsing-remitting Multiple Sclerosis
This was a randomized, partially blinded, placebo-controlled, non-confirmatory study to assess the effects of a single infusion of VAY736 on disease activity as measured by brain MRI scans in patients with relapsing-remitting…
- Trial name
- NCT02038049
- Testing
- VAY736
- Where
- 5 sites in United States, Czechia and 1 more
- Volunteers
- 8 people
- Sponsor
- Novartis Pharmaceuticals
Hepatitis C
Proof of Concept Study for Safety and Efficacy of EDP239 in Hepatitis C Subjects
The purpose of this study is, to assess whether EDP239 can reduce the HCV viral load in HCV gentotype-1 in chronically infected subjects and to further evaluate the safety profile of EDP239.
- Trial name
- NCT01856426
- Testing
- EDP239
- Where
- 5 sites in United States, Germany
- Volunteers
- 28 people
- Sponsor
- Enanta Pharmaceuticals, Inc
Severe Tinnitus
Proof-of-Concept Study Assessing VNS Paired With Tones for Tinnitus
This is a proof-of-concept study designed to provide feasibility information on the clinical use of vagus nerve stimulation (VNS) paired with tones for the treatment of severe tinnitus.
- Trial name
- NCT01253616
- Testing
- vagus nerve stimulation (VNS)
- Where
- Belgium
- Volunteers
- 10 people
- Sponsor
- MicroTransponder Inc.
Malaria
Proof-of-Concept Study of MSP3-LSP Vaccine to Protect Against Malaria in Africa
Hypothesis: The MSP3-LSP/Alum vaccine, administered to children will have a protective efficacy of at least 30% (lower bound of confidence interval of 0) against malaria disease occurring during a period beginning from 14 days…
- Trial name
- MSP3-POC (NCT01341704)
- Testing
- MSP3-LSP/AlOH, Verorab Vaccine, 0.9% NaCl/Normal Saline
- Where
- Mali
- Volunteers
- 800 people, healthy volunteers welcome
- Sponsor
- Vac4All
Distal Radius Fractures
Proof-of-concept Study With NVDX3 for Treatment of Distal Radius Fractures.
Prospective, single arm, monocentric clinical study to test NVDX3 in patients suffering from distal radius fracture. NVDX3 will be implanted during a single surgical intervention.
- Trial name
- NCT05987033
- Testing
- NVDX3
- Where
- Luxembourg
- Volunteers
- 11 people
- Sponsor
- Novadip Biosciences
Advanced Solid Tumor, Melanoma
A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors
This is a proof-of-concept study designed to investigate HER3-DXd monotherapy in locally advanced unresectable or metastatic solid tumors.
- Conditions
- Advanced Solid Tumor, Melanoma, Head and Neck Cancer, Gastric Cancer
- Trial name
- NCT06172478
- Testing
- HER3-DXd
- Where
- 96 sites in United States, Australia and 14 more
- Volunteers
- 740 people
- Sponsor
- Daiichi Sankyo
Giant Cell Arteritis
A Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis
The primary purpose of this study is to evaluate the efficacy of guselkumab compared to placebo, in combination with a 26-week glucocorticoid (GC) taper regimen, in adult participants with new-onset or relapsing giant cell…
- Trial name
- THEIA (NCT04633447)
- Testing
- Guselkumab
- Where
- 30 sites in United States, Belgium and 7 more
- Volunteers
- 53 people
- Sponsor
- Janssen Research & Development, LLC
Faecal Incontinence
The Safety and Dose Response to Single Anal Doses of NRL001
Single centre dose-finding and proof-of-concept study in healthy volunteers to assess the effects of single doses of NRL001 on the mean anal resting pressure (MARP).
- Trial name
- NCT06593743
- Testing
- Perianal NRL001 Gel 3 strengths, Intraanal NRL001 Gel 2 strengths, Intrarectal NRL001 Gel
- Where
- United Kingdom
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Norgine
Chronic Subjective Tinnitus
Study of BGG492 in Patients With Chronic Subjective Tinnitus
This study will assess the efficacy of a two week treatment with BGG492 in patients with chronic subjective Tinnitus.
- Trial name
- NCT01302873
- Testing
- BGG492A
- Where
- 4 sites in Germany, Netherlands
- Volunteers
- 96 people
- Sponsor
- Novartis Pharmaceuticals
Hidradenitis Suppurativa
A Study to Evaluate the Efficacy, Safety, and Tolerability of Guselkumab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa (HS)
The purpose of this study is to evaluate the efficacy, safety, and tolerability of guselkumab in adult participants with moderate to severe hidradenitis suppurativa (HS).
- Trial name
- NOVA (NCT03628924)
- Testing
- Guselkumab dose 1, Guselkumab dose 2, Guselkumab dose 3
- Where
- 45 sites in United States, Canada and 4 more
- Volunteers
- 184 people
- Sponsor
- Janssen Research & Development, LLC