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A Pharmacokinetic and Safety study comparing Fluticasone Propionate and Albuterol Sulfate to Fluticasone Propionate Multidose Dry Powder Inhaler (Fp MDPI) in Children Aged 4 to 11 Years Old

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Condition(s):
Respiratory
Status:
Recruiting
Requirements:
4 Years to 11 Years
Interventions:
Drug: TEV-56248
Learn more The primary objectives of this study are to determine the pharmacokinetic (PK) profile of fluticasone propionate (Fp) and albuterol sulfate (ABS), delivered in combination, from a single dose of TEV-56248 in participants with asthma, to compare the PK profiles of Fp for different dose strengths of TEV-56248 to that of fluticasone propionate multidose dry powder inhaler (Fp MDPI), and to compare the PK profiles of ABS between the 2 different strengths of TEV-56248.

A Study to Test if TEV-56286 is Effective in Relieving Multiple System Atrophy Safety and Efficacy Study (TOPAS-MSA)

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Condition(s):
Multiple System Atrophy
Status:
Recruiting
Requirements:
30 Years and older
Interventions:
Drug: TEV-56286 (emrusolmin, anle138b)
Learn more 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). 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.

A Trial to Test the Safety and Efficacy of TEV-53408 in Treating Vitiligo

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Condition(s):
Vitiligo
Status:
Recruiting
Requirements:
18 Years to 75 Years
Interventions:
Drug: TEV-53408
Learn more The primary objective of the trial is to evaluate the safety of TEV-53408 administered subcutaneously for the treatment of adults with vitiligo. Another primary objective is to evaluate the efficacy of TEV-53408. A secondary objective is to further evaluate the safety of TEV-53408. The planned study period per participant is 84 weeks including a screening period (up to 4 weeks), a 24-week open-label treatment period, a 16-week washout period, and a 40-week follow-up period.

Fixed-Dose Fluticasone Propionate/Albuterol Sulfate 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 demonstrate the efficacy of high dose and low 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). Secondary objectives are to evaluate the efficacy of Fp/ABS compared to ABS and the effect on systemic corticosteroid (SCS) exposure, and 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 35 months depending on the timing when the participant was enrolled to the study, and when the study reaches its completion criteria.

Long-Term Effect of TEV-48574 in Ulcerative Colitis or Crohn's Disease

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Condition(s):
Crohn's Disease Colitis, Ulcerative
Status:
Recruiting
Requirements:
Adult
Interventions:
Drug: TEV-48574
Learn more <p>The primary objective of the study is to evaluate the efficacy and dose response of 2 different maintenance dose regimens of TEV-48574 subcutaneous (sc) administered every 2 weeks (Q2W) in adult participants with inflammatory bowel disease (IBD) Secondary objectives of the study are to evaluate the efficacy and dose response of 2 different maintenance dose regimens of TEV-48574 sc administered Q2W in adult participants with IBD to evaluate the safety and tolerability of 2 different dose regimens of TEV-48574 sc administered Q2W in adult participants with IBD, and to evaluate the immunogenicity of 2 different dose regimens of TEV-48574 sc administered Q2W in adult participants with IBD The total duration of participant participation in the study is planned to be 26 weeks for each individual participant. The study duration is approximately 30 months..</p>

Open-Label Trial to Assess the Comparative Bioavailability of TV-44749 to Oral Olanzapine in Participants With Schizophrenia

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Condition(s):
Schizophrenia
Status:
Recruiting
Requirements:
18 Years to 64 Years
Interventions:
Drug: TV-44749
Learn more The primary objective of the study is to evaluate the comparative bioavailability of TV-44749 administered subcutaneous (sc) to oral olanzapine (ZYPREXA®) at steady state in participants with schizophrenia.

Pharmacokinetic Study of TV-44749 Extended-release in Participants with Schizophrenia

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Condition(s):
Schizophrenia, Schizoaffective Disorder
Status:
Recruiting
Requirements:
18 Years to 64 Years
Interventions:
Drug: TV-44749
Learn more The primary objective of the study is to characterize the pharmacokinetics of 3 formulations of olanzapine.

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 The primary objectives of this trial are to: -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

Safety, Tolerability, and Pharmacokinetic Study of TV-44749 in Chinese Patients With Schizophrenia

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Condition(s):
Schizophrenia
Status:
Recruiting
Requirements:
18 Years to 64 Years
Interventions:
Drug: TV-44749
Learn more The primary objective is to evaluate the safety and tolerability of single doses of TV-44749 for subcutaneous (sc) use in Chinese participants with schizophrenia.

Study to Test if Fremanezumab is Effective in Preventing Chronic Migraine in Patients 6 to 17 Years

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Condition(s):
Migraine
Status:
Recruiting
Requirements:
6 Years to 17 Years
Interventions:
Drug: Fremanezumab | Drug: Placebo
Learn more <p>The primary objective of the study is to evaluate the effectiveness of fremanezumab as compared to placebo for the preventive treatment of chronic migraine (CM).</p> <p>Secondary objectives are to further demonstrate the efficacy of Fremanezumab as compared to placebo for the preventive treatment of CM, to evaluate the safety and tolerability of Fremanezumab in the preventive treatment of CM and to evaluate the immunogenicity of Fremanezumab and the impact of antidrug antibodies (ADAs) on clinical outcomes in participants exposed to Fremanezumab</p> <p>The total duration of the study is planned to be 48 months.</p>

Study to Test if Fremanezumab is Effective in Preventing Migraine in Children and Adolescents

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Condition(s):
Migraine
Status:
Recruiting
Requirements:
6 Years to 17 Years
Interventions:
Drug: Fremanezumab
Learn more <p>The primary objective of the study is to evaluate the long-term safety and tolerability of subcutaneous fremanezumab in the preventive treatment of migraine in pediatric participants 6 to 17 years of age (inclusive at enrollment in the pivotal study).</p> <p>Secondary objectives are to evaluate the efficacy of subcutaneous fremanezumab in pediatric participants with migraine and to evaluate the immunogenicity of fremanezumab and the impact of ADAs on clinical outcomes in pediatric participants exposed to fremanezumab.</p> <p>The total duration of the study is planned to be up to 60 months.</p>

Study to Test the Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease

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Condition(s):
Crohn's Disease
Status:
Recruiting
Requirements:
Adult
Interventions:
Drug: TEV-48574 | Drug: Placebo
Learn more <p>The primary objective is to evaluate the efficacy and dose response of 3 different dose regimens of TEV-48574 in adult participants with IBD (moderate to severe Ulcerative Colitis (UC) or Crohn's Disease (CD)) as assessed by induction of clinical remission (UC) and endoscopic response (CD). Secondary objectives: -To evaluate the efficacy and dose response of the 3 different dose regimens as assessed by multiple standard measures. -To evaluate the safety and tolerability of the 3 different dose regimens. -To evaluate the immunogenicity of the 3 different dose regimens. The study will consist of a screening period of up to 6 weeks (42 days), a 14-week treatment period, and a 4-week follow-up period.</p>