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

Arlington

Arlington Research Center, Inc /ID# 250468

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

Fort Worth

Cook Children's Medical 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

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)

This trial studies the side effects of radiation therapy followed by atezolizumab in treating
patients with stage II or III non-small cell lung cancer. Hyperfractionated radiation therapy
delivers smaller doses of radiation therapy over time and may kill more tumor cells and have
fewer side effects. 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. The purpose of this study is to test the safety and effectiveness of
radiation therapy followed by atezolizumab and find out what side effects, if any, it has on
patient's non-small cell lung cancer.

Study of Radiation Therapy Followed by Atezolizumab in Stage II or III Non-small Cell Lung Cancer Patients

UT Southwestern/Simmons Cancer Center-Fort Worth

Atezolizumab

Hypofractionated Radiation Therapy

A Pilot Study of Hypofractionated Radiotherapy Followed by Atezolizumab Consolidation in Stage II or III NSCLC Patients With Borderline Performance Status

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

Nivolumab

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

Researchers are looking for a better way to treat atopic dermatitis (AD), an often
long-lasting inflammation of the skin. Atopic dermatitis, also called eczema, is causing
patches of skin to become swollen, red, cracked, and itchy.
The immune system helps protect the body from diseases. But sometimes the immune system can
be too sensitive and overreact. This may then lead to allergies but also to skin conditions
like atopic dermatitis.
The study treatment zabedosertib (BAY1834845) is currently under development for the
treatment of atopic dermatitis and other inflammatory diseases. It works by reducing the
activity of a protein called IRAK4. IRAK4 promotes the production and activation of a series
of proteins that trigger inflammation reactions in the immune cells. By reducing the activity
of IRAK4, the inflammation reactions are expected to be reduced.
The main purpose of the study is to learn how well zabedosertib works compared to placebo. A
placebo is a treatment that looks like a medicine but does not have any medicine in it. How
well it works means to find out the efficacy of zabedosertib. To answer this, the researchers
will compare how many participants had 75% EASI score reduction after 12 weeks treatment
between participants treated with zabedosertib and those treated with placebo. EASI
represents Eczema Area and Severity Index (EASI). It is a tool for measuring the amount and
severity of atopic dermatitis that a patient has on his or her body. The score ranges from
0-72, with 0 meaning clear skin and 72 meaning severe atopic dermatitis. In addition, the
itch of the study participants and other tools for measuring the severity of atopic
dermatitis will be assessed.
The secondary purpose of the study is to learn how safe it is compared to placebo. To know
this, study team will compare how many participants having adverse events after taking study
treatment between participants treated with zabedosertib and those treated with placebo.
In the study, participants will be randomly (by chance) assigned to receive zabedosertib or
placebo. The participants from both treatment groups will take zabedosertib or placebo for up
to 12 weeks.
The study consists of an up to 28-day screening period (Visits 1 and 2), a 12-week treatment
period consisting of 5 visits (Visits 3 to 7), and a 4-week follow-up visits (Visits 8).
Thus, the total study duration per participant will be 17 to 20 weeks (approximately 140
days).
During the study, the study team will:
-  take blood and urine samples
-  take skin samples (not obligatory for all patients)
-  check the participants' disease area for assessment
-  provide participants device to record their disease status and to take pictures on their
disease areas
-  have participants complete self-reported questionnaires
-  do physical examinations
-  examine heart health using ECG
-  check vital signs
-  ask the participants questions about how they are feeling and what events they are
having.
An adverse event is any problem that a participant has during a study. Doctors keep track of
all adverse events that happen in studies, even if they do not think the adverse events might
be related to the study treatments.
At 28 days after the participants take their last treatment, the study team will check if
participants have any events that might be related to the study treatment. This will be the
last visit for the study.

A Study to Learn How Well the Study Treatment Zabedosertib (BAY1834845) Works and How Safe it is Compared to Placebo in Adult Participants With Moderate-to-severe Atopic Dermatitis

Arlington Research Center, INC.

Zabedosertib (BAY1834845)

Placebo to zabedosertib (BAY 1834845)

A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter Phase 2a Study to Investigate Efficacy and Safety of Zabedosertib (BAY 1834845) for the Treatment of Adult Patients With Moderate-to-severe Atopic Dermatitis

The purpose of this study is to evaluate the efficacy of aticaprant compared with placebo as
adjunctive therapy to an antidepressant in improving depressive symptoms in adult
participants with major depressive disorder (MDD) with moderate-to-severe anhedonia (ANH+)
who have had an inadequate response to current antidepressant therapy with a selective
serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).

A Study of Aticaprant as Adjunctive Therapy in Adult Participants With Major Depressive Disorder (MDD) With Moderate-to-severe Anhedonia and Inadequate Response to Current Antidepressant Therapy

North Texas Clinical Trials

Aticrapant

Placebo

A Randomized, Double-blind, Multicenter, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Aticaprant 10 mg as Adjunctive Therapy in Adult Participants With Major Depressive Disorder (MDD) With Moderate-to-severe Anhedonia and Inadequate Response to Current Antidepressant Therapy

This Phase III, randomized, double-blind, placebo-controlled, multicenter study will evaluate
the efficacy and safety of giredestrant combined with palbociclib compared with letrozole
combined with palbociclib in patients with estrogen receptor (ER)-positive, human epidermal
growth factor receptor-2 (HER2)-negative locally advanced (recurrent or progressed) or
metastatic breast cancer.

A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer)

The Center for Cancer and Blood Disorders - Fort Worth

Giredestrant

Giredestrant-matched Placebo

Letrozole

Letrozole-matched Placebo

Palbociclib

LHRH Agonist

A Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of GDC-9545 Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Patients With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

The primary purpose of this trial is to investigate whether men with idiopathic infertility
(unexplained reduction of semen quality), after being treated with a daily dose of 12 µg
recombinant follicle stimulating hormone (rFSH) for 6 months, can improve the chance of
spontaneous pregnancy observed in their female partners in comparison to placebo (inactive
treatment).

A Trial to Compare Efficacy and Safety of Follitropin Delta Versus Placebo (Inactive Treatment) in the Treatment of Men With Idiopathic Infertility (Unexplained Reduction of Semen Quality) (ADAM)

Bedford

Ferring Investigational Site

FE 999049

A Randomised, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of FE 999049 for Treatment of Men With Idiopathic Infertility

This study will assess the safety and efficacy of ARQ-151 cream vs vehicle applied once a day
for 4 weeks by subjects with atopic dermatitis (eczema).

Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (Integument-PED)

Grapevine

Arcutis Clinical Site 61

ARQ-151 Active

ARQ-151 Vehicle

A Phase 3, 4-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.05% Administered QD in Subjects With Atopic Dermatitis

Arlington, Texas

Arlington

< 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

< 15 mi

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

< 15 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)

< 15 mi

Study of Radiation Therapy Followed by Atezolizumab in Stage II or III Non-small Cell Lung Cancer Patients

< 15 mi

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

< 0 mi

A Study to Learn How Well the Study Treatment Zabedosertib (BAY1834845) Works and How Safe it is Compared to Placebo in Adult Participants With Moderate-to-severe Atopic Dermatitis

< 15 mi

A Study of Aticaprant as Adjunctive Therapy in Adult Participants With Major Depressive Disorder (MDD) With Moderate-to-severe Anhedonia and Inadequate Response to Current Antidepressant Therapy

< 15 mi

A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer)

< 10 mi

A Trial to Compare Efficacy and Safety of Follitropin Delta Versus Placebo (Inactive Treatment) in the Treatment of Men With Idiopathic Infertility (Unexplained Reduction of Semen Quality) (ADAM)

< 15 mi

Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (Integument-PED)