Active Studies

ROCHE GA 45332

Study Overview

This study focuses on patients with moderately to severely active Crohn’s Disease (CD) who have not responded adequately to prior treatments.

Eligibility Criteria

Inclusion Criteria:

• Confirmed diagnosis of Crohn’s Disease (CD)
• Moderately to severely active CD
• Body weight ≥ 40 kilogram (kg)
• Demonstrated inadequate response, loss of response, and/or intolerance to at least one protocol-specified conventional or advanced CD therapy
• Males and females of childbearing potential must meet protocol criteria for contraception requirements

Exclusion Criteria:

• Current diagnosis of ulcerative colitis (UC) or indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, or microscopic colitis
• Participant with a history of ≥ 3 bowel resections (> 2 missing segments of the following: terminal ileum, right colon, transverse colon, sigmoid colon, left colon, and rectum)
• Diagnosis of short gut or short bowel syndrome
• Presence of an ileostomy, colostomy, or ileoanal pouch
• Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon
• Presence of abdominal or perianal abscess
• Presence of rectovaginal, enterovaginal, high-output enterocutaneous fistula, enterovesical fistulas, or perianal fistulas with more than 3 openings
• Current diagnosis or suspicion of primary sclerosing cholangitis
• Pregnancy or breastfeeding, or intention of becoming pregnant during the study
• Any past or current evidence of cancer of the gastrointestinal tract, including low-grade or high-grade colonic dysplasia
• History of non-gastrointestinal cancer, except adequately treated non-metastatic basal cell or squamous cell skin cancer or in situ cervical cancer
• Evidence of infection with Clostridioides difficile (C. difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), or Hepatitis C (HCV) during screening
• Evidence of active tuberculosis (TB), latent TB not successfully treated, or inadequately treated TB
• Has received protocol-specified prohibited medications, including known exposure to any type of anti-TL1A therapy

NOVARTIS CTQJ230A12304

Study Overview

This study evaluates treatment options for patients with atherosclerotic cardiovascular disease (ASCVD) and elevated cholesterol or lipoprotein(a) levels.

Eligibility Criteria

Inclusion Criteria

Participants must meet the following:

• Male and female participants 18 to ≤80 years of age at Screening visit
• Established ASCVD, defined as documented coronary heart disease (CHD), cerebrovascular disease (CVD), or peripheral arterial disease (PAD) at Screening visit
• On stable dose of local guideline recommended lipid lowering therapy for at least 30 days prior to Screening visit
• Participants must successfully complete the run-in period of background inclisiran treatment in order to be randomized
• On standard of care (SoC) treatment for other CVD risk factors including hypertension and diabetes for at least 30 days prior to Randomization/Baseline visit
• Central laboratory reported Lp(a) ≥175 nmol/L at Screening visit
• Central laboratory reported LDL-C >70 mg/dL (or >1.8 mmol/L) at Screening visit

Exclusion Criteria

Participants must not have:

• Prior treatment with inclisiran
• Any other PCSK9 inhibitor (e.g., evolocumab, alirocumab) use within 4 months
• prior to Screening visit
• Uncontrolled hypertension at Randomization/Baseline visit
• Heart failure New York Heart Association (NYHA) class IV at Screening visit or at Randomization/Baseline visit (Day 1)
• Triglycerides ≥400 mg/dL at Screening visit
• History of malignancy of any organ system within the past 5 years
• Myocardial infarction, stroke or other major bleeding, coronary or lower limb revascularization, major cardiac or non-cardiac surgery between Screening visit and Randomization/Baseline visit (Day 1)
• Central laboratory reported platelet count < 140,000 per mm3
• Active liver disease or hepatic dysfunction at Screening visit
• Significant kidney disease at Screening visit
• Pregnant or nursing women at Screening visit
• Any uncontrolled chronic or serious medical condition which may pose an immediate risk to clinical stability of the study participant at Screening visit
• Other protocol-defined inclusion/exclusion criteria may apply.

AMGEN 20230222

Study Overview

This study focuses on individuals at risk for cardiovascular disease associated with elevated lipoprotein(a).

Eligibility Criteria

Inclusion Criteria

Participants must meet the following:

• Age ≥50 years
• Lp(a)≥ 200 nmol/L during screening
• Multiple atherosclerotic cardiovascular disease risk factors, and/or evidence of atherosclerosis

Exclusion Criteria

Participants must not have:

• Prior acute atherothrombotic event (myocardial infarction, stroke, transient ischemic attack, acute limb ischemia)
• Prior or planned arterial revascularization
• History of major bleeding disorder