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

Wheat Ridge

Western States Clinical Res /ID# 250274

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)

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

Colorado Springs

Teva Investigational Site 14368

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

Aurora

Children's Hospital Colorado

Biospecimen Collection

Dabrafenib Mesylate

Lumbar Puncture

Magnetic Resonance Imaging

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 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

Boulder

Alpine Clinical Research Center

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 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

Loveland

McKee Medical Center

Atezolizumab

Quality-of-Life Assessment

Questionnaire Administration

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 has 2 parts: First part is the main study and second part is the extension study.
During the main study participants will receive 1 of 4 study medicines. If participants
continue in the extension study, they will not receive any study medicine during the
extension. The main study will look at how well CagriSema helps participants with excess body
weight lose weight compared to a "dummy" medicine and 2 other medicines, cagrilintide and
semaglutide. Participants will either get CagriSema, cagrilintide,semaglutide or "dummy"
medicine. Which treatment participants get is decided by chance. They will take one injection
once a week. The study medicine is injected briefly with a thin needle, typically in the
stomach, thighs or upper arms.
Extension study: After the main study, not all participants will continue in the extension
study. The study staff will tell the participant if they will continue or not into the
extension study. In the extension study we will look at what happens to the participant's
body weight and diseases related to excess body weight after the participant stops taking the
study medicine. The main study will last for about 1½ years and the extension study will last
for another 2 years.

A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight

Golden

Novo Nordisk Investigational Site

Cagrilintide

Semaglutide

Placebo cagrilintide

Placebo semaglutide

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

New West Physicians Clinical Research

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

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 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

Parker

Parker Adventist Hospital

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 III trial compares early treatment with venetoclax and obinutuzumab versus delayed
treatment with venetoclax and obinutuzumab in patients with newly diagnosed high-risk chronic
lymphocytic leukemia or small lymphocytic lymphoma. Venetoclax is in a class of medications
called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by
blocking Bcl-2, a protein needed for cancer cell survival. Immunotherapy with monoclonal
antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and
may interfere with the ability of tumor cells to grow and spread. Starting treatment with the
venetoclax and obinutuzumab early (before patients have symptoms) may have better outcomes
for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma compared to
starting treatment with the venetoclax and obinutuzumab after patients show symptoms.

Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study

Rocky Mountain Cancer Centers-Aurora

Bone Marrow Aspiration

Computed Tomography

Obinutuzumab

Venetoclax

Randomized, Phase III Study of Early Intervention With Venetoclax and Obinutuzumab Versus Delayed Therapy With Venetoclax and Obinutuzumab in Newly Diagnosed Asymptomatic High-Risk Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL): EVOLVE CLL/SLL Study

Colorado