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

West Palm Beach

Metabolic Research Inst /ID# 250046

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)

Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) is a chronic and debilitating urological
complex of disorders characterized by symptoms of bladder pain or discomfort, mostly upon
bladder filling, and often accompanied by lower urinary tract symptoms (LUTS). This study
will assess how safe and effective BOTOX (onabotulinumtoxinA) is in treating IC/BPS. Adverse
events and change in disease symptoms will be evaluated.
BOTOX (onabotulinumtoxinA) is an investigational drug being developed for the treatment of
Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS). Study doctors randomly assign the
participants to 1 of 2 groups, called treatment arms, to receive BOTOX or placebo. There is a
1 in 2 chance that participants will be assigned to placebo. Approximately 80 female
participants, aged 18 to 75 years, with a diagnosis of IC/BPS will be enrolled in
approximately 40 sites in the United States and Canada.
Participants will receive BOTOX or placebo injected into the bladder on Day 1 and will be
followed for at least 12 weeks in treatment 1. Eligible participants may request additional
dose of BOTOX between Weeks 12 and 24, and will be followed for 12 weeks in treatment period
2.
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.

Study of BOTOX Injections to Assess Change in Disease Activity and Adverse Events in Adult Female Participants With Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)

Pompano Beach

Clinical Research Center FL /ID# 243961

BOTOX

Placebo for BOTOX

A Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel Arm Study to Assess the Safety and Efficacy of a Single Treatment of BOTOX, Followed by an Optional Open-Label Treatment With BOTOX, in Female Subjects With Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)

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

Orlando

Arnold Palmer Hospital for Children

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 14250

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

Saint Mary's Hospital

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)

Izokibep is a potent and selective inhibitor of interleukin (IL)-17A that is being developed
for treatment of psoriatic arthritis (PsA).
This study will evaluate the efficacy of izokibep in subjects with PsA.

Psoriatic Arthritis Study of Izokibep

Sarasota

Clinical Research Site

Izokibep

Placebo to izokibep

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2b/3 Study to Evaluate the Efficacy and Safety of Izokibep in Subjects With Active Psoriatic Arthritis

The primary objective of this study is to evaluate the safety and efficacy of pitolisant
compared with placebo in treating excessive daytime sleepiness (EDS) in patients with
idiopathic hypersomnia (IH) age ≥18 years.
Key secondary objectives of this study are to assess the impact of pitolisant on:
-  Overall symptoms of IH
-  Patient impression of overall change in their symptoms of IH
-  Investigator assessment of overall disease severity of IH
Other secondary objectives of this study are to assess the impact of pitolisant in patients
with IH on:
-  Patient impression of overall severity of their EDS
-  Functional status and activities of daily living
-  Sleep-related impairment
-  Sleep inertia
-  Cognitive function

A Phase 3 Study to Assess the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia

Winter Park

Florida Pediatric Research Institute

Pitolisant Oral Tablet

Placebo oral tablet

A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Evaluate the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia

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

Tallahassee

Tallahassee Memorial Healthcare Cancer Center

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 phase III trial studies how well atezolizumab added to the usual radiation therapy works
in treating patients with stage I-IIA non-small cell lung cancer. Immunotherapy with
monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the
cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation
therapy, such as stereotactic body radiation therapy, uses special equipment to position a
patient and deliver radiation to tumors with high precision. This method can kill tumor cells
with fewer doses over a shorter period and cause less damage to normal tissue. Giving
atezolizumab and radiation therapy may work better than radiation therapy alone in treating
patients with early non-small cell lung cancer.

Testing the Addition of the Drug Atezolizumab to the Usual Radiation Treatment for Patients With Early Non-small Cell Lung Cancer

Sarasota Memorial Health Care Center at University Parkway

Atezolizumab

Stereotactic Body Radiation Therapy

A Randomized Phase III Trial of Induction/Consolidation Atezolizumab (NSC #783608) + SBRT Versus SBRT Alone in High Risk, Early Stage NSCLC

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

Florida