Jarom¿¿, Czech Republic
To Assess the Safety and Efficacy of SP-002 with Vismodegib for the Treatment of Locally Advanced Basal Cell Carcinoma
This is a Phase 2, 3-arm, multi-center, open-label, randomized, clinical study to evaluate the efficacy of SP-002 in combination with vismodegib in subjects with locally advanced Basal cell carcinoma. The study will be completed in 2 consecutive parts. Each part consists of a screening period, a treatment period, and a follow-up period. - Part A: 20 participants who meet study entry criteria will be randomized in a 1:1 ratio into 2 treatment arms (Arm 2 and Arm 3) and will provide preliminary safety and performance in a population with target Basal cell carcinoma lesions. - Part B: 60 participants who meet study entry criteria will be randomized in a 1:1:1 ratio into 3 treatment arms (Arm 1, Arm 2, and Arm 3) in a population with target Basal cell carcinoma lesions.
Phase
2Span
260 weeksSponsor
Stamford Pharmaceuticals, Inc.Cedar Park, Texas
Recruiting
Safety and Effectiveness of Endoscopic Intestinal Re-Cellularization Therapy in Individuals With Type II Diabetes
This is a prospective, multi-center, randomized, double-blind, sham-controlled, adaptive study enrolling individuals with type 2 diabetes inadequately controlled on non-insulin glucose-lowering medications. Participants will be randomized to receive the ReCET therapy or sham procedure consisting of device insertion without treatment. Participants will be followed for 6 months for the primary endpoint and 12 months in total. After 12 months, participants randomized to the sham arm may cross-over to receive the ReCET procedure.
Phase
N/ASpan
127 weeksSponsor
Endogenex, Inc.Austin, Texas
Recruiting
Video Vitals and Biomarkers
Phase
N/ASpan
100 weeksSponsor
Maiv Health Inc.Cedar Park, Texas
Recruiting
Maestro 1.1 Post-Market Registry
Phase
N/ASpan
118 weeksSponsor
Moon SurgicalCedar Park, Texas
Recruiting
A Study to Investigate Vaccine Responses in Subcutaneous Amlitelimab Treated Atopic Dermatitis Participants Aged 18 Years and Older Compared With Placebo
The study duration will be up to 36 weeks
Phase
2Span
125 weeksSponsor
SanofiCedar Park, Texas
Recruiting
A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease
The drug being tested in this study is vedolizumab. Vedolizumab is being tested to treat people with moderate to severe Crohn's disease who have experienced inadequate response, loss of response or intolerance to either one prior interleukin [IL] antagonist (Cohort 1) or one prior tumor necrosis factor inhibitor [TNFi] (Cohort 2). The study will look at the efficacy and safety of dual targeted therapy. The study will enroll approximately 150 patients. Participants will be assigned to one of the two treatment groups in Part A: - Part A, Cohort 1: Vedolizumab + Adalimumab - Part A, Cohort 2: Vedolizumab + Ustekinumab All participants who achieve clinical remission in Part A will receive vedolizumab IV 300 mg monotherapy from Week 30 until Week 46 in Part B. Participants will be followed for a further 20-week safety follow-up period to Week 72 (or 26 weeks post-last dose of study drug). This multi-center trial will be conducted in the United States and Canada. The overall time to participate in this study is approximately 76 weeks.
Phase
4Span
167 weeksSponsor
TakedaCedar Park, Texas
Recruiting
A Study to Evaluate the Safety and Immunogenicity of the mRNA COVID-19 Vaccines in Healthy Children Between 6 Months to Less Than 6 Years of Age
Part 1 will enroll participants aged 6 months to <6 years who have not been previously vaccinated against SARS-CoV-2. Participants will receive 2 doses of the mRNA-1273.214 vaccine. Part 2 will enroll participants aged 6 months to <6 years who have previously been vaccinated with a mRNA-1273 primary series in Study mRNA-1273-P204 (NCT04796896). Participants will receive a single BD of the mRNA-1273.214 vaccine, at least 4 months after completion of the mRNA-1273 primary series. Part 3 will enroll participants aged 6 months to <6 years who have previously been vaccinated with an authorized/approved COVID-19 vaccine. Participants will receive a BD of the mRNA-1273.815 vaccine at least 4 months after the last receipt of a COVID-19 vaccine. Part 4 will evaluate mRNA-1273.815 vaccine administered as a single dose to SARS-CoV-2 vaccine-naïve participants aged 2 years to <5 years of age enrolled in Cohort A (Part 4A), compared to 2 doses given to SARS-CoV-2 vaccine-naïve participants aged 6 months to <2 years enrolled in Cohort B (Part 4B).
Phase
3Span
175 weeksSponsor
ModernaTX, Inc.Cedar Park, Texas
Recruiting
Healthy Volunteers
ABTECT - Maintenance
All eligible subjects who have completed either one of the induction studies above mentioned, will be given the opportunity to take part in the present ABX464-107 study which consists of 2 treatment phases. This study consists of a 44-week maintenance treatment phase (Part 1 and Part 2), followed by a 4-year Long Term Extension (LTE) treatment phase and a 28-days follow-up period consisting in the End of Study (EOS) visit. The maintenance phase is a 44-week double blind, placebo-controlled, phase. Subjects who are clinical responders after 8 weeks induction will be randomized to Part 1, and those who are non-clinical responders will be randomized to Part 2. At the end of the 44-week maintenance phase, subjects will continue their allocated treatment until the maintenance phase is unblinded. Once the study is unblinded, all subjects receiving obefazimod will continue their allocated treatment. Subjects receiving placebo will be allocated to obefazimod 25 mg or can terminate the study.
Phase
3Span
368 weeksSponsor
Abivax S.A.Cedar Park, Texas
Recruiting
ABTECT-1 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -1
Phase
3Span
134 weeksSponsor
Abivax S.A.Cedar Park, Texas
Recruiting
Study to Evaluate the Efficacy and Safety of K-877-ER and CSG452 in Participants With NASH With Liver Fibrosis
Phase
2Span
177 weeksSponsor
Kowa Research Institute, Inc.Cedar Park, Texas
Recruiting