Clinical Trials & Results

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A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/​Albuterol Sulfate is Effective in Preventing Asthma Exacerbations

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Condition(s):
Asthma
Status:
Recruiting
Requirements:
4 years and older
Interventions:
Drug: TEV-56248 | Drug: Albuterol sulfate
Learn more The primary objective of the study is to assess the efficacy of high dose fluticasone propionate (Fp)/albuterol sulfate (ABS) integrated electronic module multidose dry powder inhaler (eMDPI) compared to ABS eMDPI in decreasing severe clinical asthma exacerbation (CAEs). The secondary objectives are: To evaluate the efficacy of Fp/ABS low dose compared to ABS and the effect on systemic corticosteroid (SCS) exposure. To evaluate the safety and tolerability of Fp/ABS.The duration for each participant will be a minimum of 28 weeks including 2 weeks of screening, 2-4 weeks of run-in period and a double blind treatment period of minimum 24 weeks, however due to the event-driven nature of this study, the duration may range up to approximately 42 months depending on the timing when the participant was enrolled to the study, and when the study reaches its completion criteria.

A Trial to Test if TEV-56286 is Effective for Treatment of Participants With Multiple System Atrophy (TOPAS-MSA)

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Condition(s):
Multiple System Atrophy
Status:
Recruiting
Requirements:
30 years to 75 years
Interventions:
Drug: TEV-56286 (emrusolmin, anle138b)
Learn more Primary objectives: The primary objective of the study is to evaluate the efficacy of TEV-56286 administered orally for the treatment of adult participants with Multiple System Atrophy (MSA). Secondary objectives: A secondary objective of the study is to evaluate specific efficacy parameters of TEV-56286. Another secondary objective is to evaluate the safety and tolerability of TEV-56286. The planned study period per participant is 56 weeks including a screening period (up to 4 weeks), a 48-week double-blind treatment period, and a follow-up visit (approximately 4 weeks after the end of the double-blind treatment period). The study duration will be approximately 27 months.

An Extension Trial to Test if TEV-56286 is Effective in Relieving Multiple System Atrophy

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Condition(s):
Multiple System Atrophy
Status:
Recruiting
Requirements:
30 years and older
Interventions:
Drug: TEV-56286
Learn more The primary objective of the trial is to describe the long-term safety and tolerability of TEV-56286 administered orally for the treatment of adult participants with Multiple System Atrophy (MSA). A secondary objective of the trial is to further describe the safety and tolerability of TEV-56286. The planned total duration of the trial is approximately 100 weeks

Efficacy and Safety of Fluticasone Propionate/​Albuterol Sulfate Combination in Participants 12 Years and Older With Asthma

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Condition(s):
Asthma
Status:
Recruiting
Requirements:
12 Years and older
Interventions:
Drug: Fp/ABS, FP, ABS, Placebo
Learn more Primary objectives: The primary objective of the trial is to evaluate the efficacy of fluticasone propionate/albuterol sulfate multidose dry powder inhaler with electronic module (Fp/ABS eMDPI). Secondary objective:To evaluate the efficacy of Fp/ABS eMDPI administered four times dailyTo evaluate the safety and tolerability of Fp/ABS eMDPI administered four times daily over four weeksTo investigate the pharmacokinetics of Fp/ABS eMDPI, ABS eMDPI and Fp eMDPI after administration of a single doseThe planned study duration for each participant is approximately 10 weeks, excluding an optional prescreening visit.

Safety and Activity of TEV-56278, as a Monotherapy and in Combination with Pembrolizumab in Participants with Selected Locally Advanced or Metastatic Solid Tumors

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Condition(s):
Advanced Solid Tumors
Status:
Recruiting
Requirements:
18 Years to 64 Years
Interventions:
Drug: TEV-56278
Learn more Primary objectives: Characterize the safety and tolerability of TEV-56278 -Determine the Recommended Phase 2 Dose (RP2D). Evaluate antitumor activity of TEV-56278 -Determine the safety and tolerability of TEV-56278 in combination with pembrolizumab. Determine a RP2D of TEV-56278 in combination with pembrolizumab