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

Houston

Center for Clinical Studies /ID# 250039

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)

Advances in Health, Inc. /ID# 240850

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

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

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 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

Tomball

Northwest Houston Neurology and Sleep

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

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

Novo Nordisk Investigational Site

Cagrilintide

Semaglutide

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 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

Radiation Therapy

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)

The study consists of Safety Run-in and Phase 2 Cohorts.
The primary objectives of the safety run-in cohorts of this study are to evaluate the safety,
tolerability, and recommended Phase 2 dose (RP2D) of magrolimab in combination with
pembrolizumab + 5-fluorouracil (5-FU) + platinum chemotherapy, and docetaxel in combination
with magrolimab in participants with head and neck squamous cell carcinoma (HNSCC).
Phase 2 Cohorts 1: To evaluate the progression-free survival (PFS) with magrolimab in
combination with pembrolizumab + 5-FU + platinum versus pembrolizumab + 5-FU + platinum as
assessed by independent central review.
Phase 2 Cohorts 2 and 3: To evaluate the efficacy of magrolimab in combination with
pembrolizumab and magrolimab in combination with docetaxel as determined by the
investigator-assessed objective response rate (ORR).

Study of Magrolimab Combination Therapy in Participants With Head and Neck Squamous Cell Carcinoma

MD Anderson Cancer Center

Magrolimab

Pembrolizumab

Docetaxel

5-FU

Cisplatin

Carboplatin

Zimberelimab

A Phase 2 Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma

The purpose of this is study is to compare the efficacy of BHV-3500 (zavegepant) to placebo
as a preventive treatment for migraine, as measured by the reduction in the number of
migraine days per month.

A Study to Evaluate the Efficacy and Safety of Oral Zavegepant in Migraine Prevention

DM Clinical Research

BHV-3500 (zavegepant)

Placebo

A Phase 2/3 Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Oral Zavegepant in Migraine Prevention

This phase Ib trial studies the side effects of nivolumab and to see how well it works in
treating patients with autoimmune disorders and cancer that has spread to other places in the
body or cannot removed by surgery. Immunotherapy with monoclonal antibodies, such as
nivolumab, may help the body's immune system attack the cancer, and may interfere with the
ability of tumor cells to grow and spread.

Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer

M D Anderson Cancer Center

Nivolumab

A Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)

This study is designed to assess the antitumor efficacy and safety of pembrolizumab in
combination with BCG, compared to BCG monotherapy, in participants with HR NMIBC that is
either persistent or recurrent following adequate BCG induction (Cohort A), or that is naïve
to BCG treatment (Cohort B). The primary hypothesis for Cohort A is that the combination of
pembrolizumab plus BCG has a superior complete response rate (CRR) as assessed by central
pathology review compared to BCG in participants with carcinoma in situ (CIS). The primary
hypothesis for Cohort B is that the combination of pembrolizumab plus BCG (either reduced
maintenance or full maintenance) has a superior Event Free Survival (EFS) compared to BCG.

Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676)

Houston Metro Urology ( Site 1111)

A Phase 3, Randomized, Comparator-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in Participants With High-risk Non-muscle Invasive Bladder Cancer (HR NMIBC) That is Either Persistent or Recurrent Following BCG Induction or That is Naïve to BCG Treatment (KEYNOTE-676)

Houston, Texas

Houston

< 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

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)

< 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

< 30 mi

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

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

< 0 mi

Study of Magrolimab Combination Therapy in Participants With Head and Neck Squamous Cell Carcinoma

< 30 mi

A Study to Evaluate the Efficacy and Safety of Oral Zavegepant in Migraine Prevention

< 0 mi

Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer

< 0 mi

Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676)