Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to
inflammation of the skin. Therapies spread over the skin may not be enough to control the AD
in trial participants who require systemic anti-inflammatory treatment. This study compares
upadacitinib to dupilumab in adolescent and adult participants with moderate to severe AD who
have inadequate response to systemic therapies. Adverse events and change in the disease
activity will be assessed.
Upadacitinib and dupilumab are approved drugs for the treatment of moderate to severe atopic
dermatitis (AD). The study is comprised of a 35-day Screening Period, a 16-week treatment
period 1 and a 16-week treatment period 2. During period 1, participants are randomly
assigned in 1 of 2 groups, called treatment arms to receive upadacitinib Dose A or dupilumab.
In Period 2, participants will receive upadacitinib Dose A or Dose B. Approximately 880
adolescent and adult participants ages 12 to 64 with moderate to severe AD who are candidates
for systemic therapy will be enrolled at up to 330 sites worldwide.
Participants will receive upadacitinib oral tablets once daily or dupilumab as per its label
for 32 weeks and followed for 30 days.
There may be higher treatment burden for participants in this trial compared to their
standard of care . Participants will attend regular visits during the study at a hospital or
clinic. The effect of the treatment will be checked by medical assessments, blood tests,
checking for side effects and completing questionnaires.

A Study to Evaluate Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis

Jacksonville

Solutions Through Adv Rch /ID# 250455

Upadacitinib

Dupilumab

A Phase 3b/4 Randomized, Open-label, Efficacy Assessor Blinded Study, Comparing the Safety and Assessor Blinded Efficacy of Upadacitinib to Dupilumab in Subjects With Moderate to Severe Atopic Dermatitis (Level-Up)

This phase III trial investigates the best dose of vinblastine in combination with
selumetinib and the benefit of adding vinblastine to selumetinib compared to selumetinib
alone in treating children and young adults with low-grade glioma (a common type of brain
cancer) that has come back after prior treatment (recurrent) or does not respond to therapy
(progressive). Selumetinib is a drug that works by blocking a protein that lets tumor cells
grow without stopping. Vinblastine blocks cell growth by stopping cell division and may kill
cancer cells. Giving selumetinib in combination with vinblastine may work better than
selumetinib alone in treating recurrent or progressive low-grade glioma.

A Study to Compare Treatment With the Drug Selumetinib Alone Versus Selumetinib and Vinblastine in Patients With Recurrent or Progressive Low-Grade Glioma

Nemours Children's Clinic-Jacksonville

Biospecimen Collection

Magnetic Resonance Imaging

Quality-of-Life Assessment

Questionnaire Administration

Selumetinib Sulfate

Vinblastine Sulfate

A Phase 3 Study of Selumetinib (NSC# 748727) or Selumetinib in Combination With Vinblastine for Non-NF1, Non-TSC Patients With Recurrent or Progressive Low-Grade Gliomas (LGGs) Lacking BRAFV600E or IDH1 Mutations

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).
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
The total duration of the study is planned to be 48 months.

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

Teva Investigational Site 14244

Fremanezumab

Placebo

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study Comparing the Efficacy, Safety, and Tolerability of Subcutaneous Administration of Fremanezumab Versus Placebo for the Preventive Treatment of Chronic Migraine in Pediatric Patients 6 to 17 Years of Age

This phase II trial studies how well the combination of dabrafenib and trametinib works after
radiation therapy in children and young adults with high grade glioma who have a genetic
change called BRAF V600 mutation. Radiation therapy uses high energy rays to kill tumor cells
and reduce the size of tumors. Dabrafenib and trametinib may stop the growth of tumor cells
by blocking BRAF and MEK, respectively, which are enzymes that tumor cells need for their
growth. Giving dabrafenib with trametinib after radiation therapy may work better than
treatments used in the past in patients with newly-diagnosed BRAF V600-mutant high-grade
glioma.

Dabrafenib Combined With Trametinib After Radiation Therapy in Treating Patients With Newly-Diagnosed High-Grade Glioma

Dabrafenib Mesylate

Lumbar Puncture

Radiation Therapy

Trametinib Dimethyl Sulfoxide

A Phase 2 Study of Dabrafenib (NSC# 763760) With Trametinib (NSC# 763093) After Local Irradiation in Newly-Diagnosed BRAF V600-Mutant High-Grade Glioma (HGG)

The primary objective of this study for the safety run-in cohorts of the study is to evaluate
the safety, tolerability, and recommended Phase 2 dose (RP2D) of magrolimab in combination
with nab-paclitaxel or paclitaxel (Safety Run-In Cohort 1), and sacituzumab govitecan (Safety
Run-In Cohort 2) in metastatic triple-negative breast cancer (mTNBC).
The primary objective of this study for Phase 2 Cohort 1 is to compare the efficacy of
magrolimab in combination with nab-paclitaxel or paclitaxel versus nab-paclitaxel or
paclitaxel alone, as determined by progression-free survival (PFS) by investigator
assessment.
The primary objective of this study for Phase 2 Cohort 2 is to evaluate the efficacy of
magrolimab in combination with sacituzumab govitecan as determined by confirmed objective
response rate (ORR) by investigator assessment.

Study to Evaluate the Safety and Efficacy of Magrolimab Combination Therapy in Adults With Unresectable, Locally Advanced or Metastatic Triple-Negative Breast Cancer

Mayo Clinic

Magrolimab

Nab-Paclitaxel

Paclitaxel

Sacituzumab govitecan

A Phase 2 Study of Magrolimab Combination Therapy in Patients With Unresectable, Locally Advanced or Metastatic Triple-Negative Breast Cancer

This study will look at how much weight participants will lose from the start to the end of
the study. The weight loss in participants taking the investigational high dose of
semaglutide will be compared to the weight loss in people taking "dummy" medicine and a lower
dose of semaglutide. In addition to taking the medicine, participants will have talks with
study staff about healthy food choices and how to be more physically active. Participants
will either get semaglutide or "dummy" medicine. Which treatment participants get is decided
by chance. Participants are more likely (4 out of 5) to get semaglutide than the "dummy"
medicine. The study medicine will be injected briefly, under skin, with a thin needle,
typically in the stomach, thighs, or upper arms. In the first part of the study, participants
will get one injection once a week until they reach the planned dose. The second part of the
study, which might last a couple of months, is a transition period, where participant will
get three injections, taken right after each other, once a week. The duration of the study
intervention (trial product and lifestyle intervention) will be 72 weeks followed by a 9-week
follow-up period without study interventions.

A Research Study to See How Semaglutide Helps People With Excess Weight, Lose Weight (STEP UP)

Novo Nordisk Investigational Site

Semaglutide

Effect and Safety of Semaglutide 7.2 mg Once-weekly in Participants With Obesity

This study will investigate the effect of tirzepatide on the reduction of morbidity and
mortality in adults living with obesity and provide additional evidence for the potential
clinical benefits of tirzepatide in this population.

A Study of Tirzepatide (LY3298176) on the Reduction on Morbidity and Mortality in Adults With Obesity

Northeast Research Institute - Downtown Office

Tirzepatide

A Phase 3, Randomized, Double-blind, Placebo-Controlled Study to Investigate the Effect of Tirzepatide on the Reduction of Morbidity and Mortality in Adults With Obesity

This study will look at how well the new medicine CagriSema helps people living with excess
body weight and type 2 diabetes losing weight. Participants will either get CagriSema or a
dummy medicine. Which treatment they get is decided by chance.
The study will last for about 1½ years. Women cannot take part if pregnant, breast-feeding or
plan to get pregnant during the study period.

A Research Study to See How Well CagriSema Helps People With Type 2 Diabetes and Excess Body Weight Lose Weight

Cagrilintide

Placebo cagrilintide

Placebo semaglutide

Efficacy and Safety of Cagrilintide s.c. 2.4 mg in Combination With Semaglutide s.c. 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) Once-weekly in Participants With Overweight or Obesity and Type 2 Diabetes

This study is being done to see if tucatinib works better than placebo when given with other
drugs to treat participants with HER2-positive breast cancer. A placebo is a pill that looks
the same as tucatinib but has no medicine in it. This study will also test what side effects
happen when participants take this combination of drugs. A side effect is anything a drug
does to the body besides treating your disease.
Participants will have cancer that has spread in the body near where it started (locally
advanced) and cannot be removed (unresectable) or has spread through the body (metastatic).
In this study, all participants will get either tucatinib or placebo. Participants will be
assigned randomly to a group. This is a blinded study, so patients and their doctors will not
know which group a participant is in.
All participants will also get trastuzumab and pertuzumab. These are 2 drugs used to treat
this type of cancer.

A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer

Mayo Clinic Florida

Tucatinib

Trastuzumab

Pertuzumab

Combination product: Trastuzumab + Pertuzumab

A Randomized, Double-blind, Phase 3 Study of Tucatinib or Placebo in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy for Metastatic HER2+ Breast Cancer (HER2CLIMB-05)

This phase I/II trial tests the safety, side effects, and best dose of selinexor given in
combination with standard radiation therapy in treating children and young adults with newly
diagnosed diffuse intrinsic pontine glioma (DIPG) or high-grade glioma (HGG) with a genetic
change called H3 K27M mutation. It also tests whether combination of selinexor and standard
radiation therapy works to shrink tumors in this patient population. Glioma is a type of
cancer that occurs in the brain or spine. Glioma is considered high risk (or high-grade) when
it is growing and spreading quickly. The term, risk, refers to the chance of the cancer
coming back after treatment. DIPG is a subtype of HGG that grows in the pons (a part of the
brainstem that controls functions like breathing, swallowing, speaking, and eye movements).
This trial has two parts. The only difference in treatment between the two parts is that some
subjects treated in Part 1 may receive a different dose of selinexor than the subjects
treated in Part 2. In Part 1 (also called the Dose-Finding Phase), investigators want to
determine the dose of selinexor that can be given without causing side effects that are too
severe. This dose is called the maximum tolerated dose (MTD). In Part 2 (also called the
Efficacy Phase), investigators want to find out how effective the MTD of selinexor is against
HGG or DIPG. Selinexor blocks a protein called CRM1, which may help keep cancer cells from
growing and may kill them. It is a type of small molecule inhibitor called selective
inhibitors of nuclear export (SINE). Radiation therapy uses high energy to kill tumor cells
and shrink tumors. The combination of selinexor and radiation therapy may be effective in
treating patients with newly-diagnosed DIPG and H3 K27M-Mutant HGG.

A Study of the Drug Selinexor With Radiation Therapy in Patients With Newly-Diagnosed Diffuse Intrinsic Pontine (DIPG) Glioma and High-Grade Glioma (HGG)

Biopsy

Selinexor

A Phase 1/2 Trial of Selinexor (KPT-330) and Radiation Therapy in Newly-Diagnosed Pediatric Diffuse Intrinsic Pontine Glioma (DIPG) and High-Grade Glioma (HGG)

Jacksonville, Florida

Jacksonville

< 0 mi

A Study to Evaluate Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis

< 0 mi

A Study to Compare Treatment With the Drug Selumetinib Alone Versus Selumetinib and Vinblastine in Patients With Recurrent or Progressive Low-Grade Glioma

< 0 mi

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

< 0 mi

Dabrafenib Combined With Trametinib After Radiation Therapy in Treating Patients With Newly-Diagnosed High-Grade Glioma

< 0 mi

Study to Evaluate the Safety and Efficacy of Magrolimab Combination Therapy in Adults With Unresectable, Locally Advanced or Metastatic Triple-Negative Breast Cancer

< 0 mi

A Research Study to See How Semaglutide Helps People With Excess Weight, Lose Weight (STEP UP)

< 0 mi

A Study of Tirzepatide (LY3298176) on the Reduction on Morbidity and Mortality in Adults With Obesity

< 0 mi

A Research Study to See How Well CagriSema Helps People With Type 2 Diabetes and Excess Body Weight Lose Weight

< 0 mi

A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer

< 0 mi

A Study of the Drug Selinexor With Radiation Therapy in Patients With Newly-Diagnosed Diffuse Intrinsic Pontine (DIPG) Glioma and High-Grade Glioma (HGG)