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

Phoenix

Alliance Dermatology and MOH Center, PC /ID# 249671

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 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

Phoenix Childrens Hospital

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

Scottsdale

Mayo Clinic

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

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 ALCHEMIST trial studies genetic testing in screening patients with stage IB-IIIA
non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in
a patient's tumor cells may help doctors select the best treatment for patients that have
certain genetic changes.

Genetic Testing in Screening Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (The ALCHEMIST Screening Trial)

Gilbert

Banner MD Anderson Cancer Center

Carboplatin

Cisplatin

Clinical Observation

Crizotinib

Cytology Specimen Collection Procedure

Erlotinib

Gemcitabine Hydrochloride

Nivolumab

Pembrolizumab

Pemetrexed

Pemetrexed Disodium

Placebo Administration

Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)

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

Tucson

Pima Heart

Tirzepatide

Placebo

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 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 Arizona

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)

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

Chandler

Ironwood Cancer and Research Center

Docetaxel

5-FU

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

Tuscon Neuroscience Research, LLC

BHV-3500 (zavegepant)

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

This study will evaluate the efficacy, safety, and pharmacokinetics of obinutuzumab compared
with placebo in patients with International Society of Nephrology/Renal Pathology Society
(ISN/RPS) class III or IV lupus nephritis (LN) when added on to standard-of-care therapy
consisting of mycophenolate mofetil (MMF) and corticosteroids.

A Study To Evaluate The Efficacy And Safety Of Obinutuzumab In Patients With ISN/RPS 2003 Class III Or IV Lupus Nephritis

Arizona arthritis and Rheumatology Research PLLC

Obinutuzumab

Prednisone

Methylprednisolone

Acetaminophen

Diphenhydramine

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy And Safety Of Obinutuzumab In Patients With ISN/RPS 2003 Class III Or IV Lupus Nephritis (REGENCY)

Arizona