Alzheimer's Disease

A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2)

Inclusion Criteria:

  • Gradual and progressive change in memory function reported by participants or informants for ≥ 6 months

  • MMSE score of 20 to 28 (inclusive) at baseline

  • Meet 18F flortaucipir PET scan (central read) criteria

  • Meet 18F florbetapir PET scan (central read) criteria

  • Have a study partner who will provide written informed consent to participate

Exclusion Criteria:

  • Contraindication to MRI or PET scans

  • Current treatment with immunoglobulin G (IgG) therapy

Endometriosis Pain

 

A Phase 3  prospective, randomized, double-blind, placebo-controlled study to demonstrate the efficacy and safety of linzagolix administered orally once daily at doses of 75 mg alone and 200 mg in combination with low dose ABT (E2 1 mg/NETA 0.5 mg) versus placebo in the management of moderate to severe Endometriosis pain in 450 women.

Eligible subjects who have completed the 6-month treatment period may enter a separate extension study for 6 additional months of active treatment (no placebo control). Subjects who do not continue in the extension study will enter a 6-month treatment-free follow-up phase.

Key Inclusion Criteria:

The subject must have:

  • Her most recent surgical and - if available - histological diagnosis of pelvic endometriosis up to 10 years before screening.

  • Moderate to severe endometriosis-associated pain during the screening period.

  • Regular menstrual cycles.

  • BMI ≥ 18 kg/m2 at the screening visit.

Key Exclusion Criteria:

The subject will be excluded if she:

  • Is pregnant or breastfeeding or is planning a pregnancy within the duration of the treatment period of the study.

  • Is less than 6 months postpartum or 3 months postabortion/ miscarriage at the time of entry into the screening period.

Alzheimer's Disease 

This Phase 3, 36-month study (41 office visits) assesses the safety and efficacy of gantenerumab in patients with early, prodromal to mild Alzheimer's disease. 

Inclusion/Exclusion Criteria:

  • Males or Females 50-90 years old at screening.

  • Evidence of AD pathological process as confirmed by amyloid PET scan or CSF Tau.

  • Demonstrate abnormal memory functions during testing at screening.

  • Has an available study partner (a person who has frequent and sufficient contact with the patient).

Stress Urinary Incontinence 

Pursuit- Prospective US Radiofrequency SUI trial is for premenopausal women who leak urine during certain activities, including exercising, laughing, coughing, sneezing or other physical activities related to stress urinary incontinence (SUI)

Inclusion Criteria:

  • Pre-menopausal females, ≥ 18 years of age. Premenopausal is defined as a woman who has had menstrual cycles over the previous 12 months.

  • Subjects with a BMI of ≤ 35 kg/m².

  • 1-hr pad weight at Baseline with a 5 to 50 g net increase from the pre-test pad weight

Exclusion Criteria:

  • Subjects who are currently breastfeeding or have discontinued breastfeeding fewer than 6 months prior to screening.

  • Subjects who are pregnant or plan to become pregnant during the course of the study.

  • Subjects who have undergone other stress urinary incontinence treatments, excluding behavioral modifications (e.g., Kegel exercises).

  • Has any implantable electrical device [e.g., implantable pacemaker, automatic implantable cardioverter-defibrillator (AICD)].

  • Subjects who have started or changed dose of local vaginal hormones <6 weeks before Screening.

  • Subjects who have started pelvic floor physical therapy within the last 3 months.

  • Undergone previous elective surgical or non-invasive procedure(s) in the vaginal canal (including the Viveve Treatment or any other genital radiofrequency treatment; injectable bulking agent, cosmetic, laser, surgical, and/or genital enhancement procedure, and previous dilation and cuterage within 12 months of the subject's Pre-Screening Visit).

COPD (Chronic Obstructive pulmonary disease)

A Phase III Study Comparing Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination CHF 5993 With the Fixed Dose Dual Combination CHF 1535 in Subjects With COPD (TRITON)

Ages Eligible for Study:  40 Years and older  

 

Inclusion Criteria:

  • Signed and dated written informed consent must be obtained prior to initiating any study-related procedures

  • Outpatient

  • Male or female subjects aged ≥40 years

  • A female is eligible to participate in the study if she is of non-childbearing potential defined as physiologically incapable of becoming pregnant OR childbearing potential with negative serum and urine pregnancy tests at screening, and is willing to use highly effective birth control methods for the full duration of the study

  • COPD diagnosis for at least 12 months before the screening visit in accordance with the definition by the GOLD 2020 Report

  • Current or ex-smokers who quit smoking at least 6 months prior to screening with a smoking history of at least 10 pack-years [pack-years = (number of cigarettes per day x number of years)/20]

Exclusion Criteria:

  • Female subjects who are pregnant (as evident by a positive urine hCG or serum β-hCG test) or lactating

  • Subjects using the following medications prior to the screening visit and during the run-in period:

    1. Systemic/oral/parenteral corticosteroids in the prior 4 weeks

    2. Use of antibiotics for a lower respiratory tract infection (e.g. pneumonia) or COPD exacerbation in the prior 4 weeks

    3. Any long-term chronic maintenance use of antibiotic treatment in the prior 4 weeks

    4. Oral xanthine derivatives (e.g. theophylline) in the prior 7 days

  • A moderate or severe COPD exacerbation or a respiratory tract infection (e.g., pneumonia) that has not resolved ≤14 days prior to the screening visit or during the run-in period

  • Current treatment with non-cardioselective β-blockers

  • Requirement of long term (> 15 hours daily) oxygen therapy