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

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).

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.

Psoriatic Arthritis

A Phase 3, Randomized, Double-blind, Placebo and Adalimumab-controlled Study to Evaluate the Efficacy and Safety of Filgotinib in Subjects With Active Psoriatic Arthritis Who Are Naive to Biologic DMARD Therapy

Ages Eligible for Study:  18 Years to 75 Years  

 

Key Inclusion Criteria:

  • Meet Classification Criteria for Psoriatic Arthritis (CASPAR) and have a history consistent with PsA ≥ 6 months at Screening

  • Have active PsA defined as ≥ 3 swollen joints (from a 66 swollen joint count [SJC]) and ≥ 3 tender joints (from a 68 tender joint count [TJC]) at Screening and Day 1; these may or may not be the same joints at Screening and Day 1

  • Must have a documented history or active signs of at least one of the following at Screening:

    • Plaque psoriasis

    • Nail changes attributed to psoriasis

  • Have had inadequate response or intolerance to ≥1 conventional synthetic disease-modifying anti-rheumatic drug (csDMARD), apremilast and/or NSAID, administered over the course of ≥ 12 weeks for the treatment of PsA, as per local guidelines/standard of care

Key Exclusion Criteria:

  • Prior PsA or psoriasis treatment with a biologic DMARD

  • Prior exposure to a Janus kinase (JAK) inhibitor > 2 doses

  • Any active/recent infection

  • Any chronic and/or uncontrolled medical condition that would put the individual at increased risk during study participation or circumstances which may make an individual unlikely or unable to complete or comply with study procedures and requirements, per investigator judgment

Hot Flashes

There are two new hot flash studies offered. Both are Phase 3 studies comparing a medication for moderate to severe hot flashes associated with menopause against a placebo. 

Inclusion/Exclusion Criteria:

  • Female between the ages of 40 to 65 years old.

  • Must be seeking treatment for Hot Flashes associated with menopause

  • Must be willing to undergo an endometrial biopsy

  • Must be in good general health 

Uterine Fibroids 

This Phase 3, 45-week study (8

 office visits) is to evaluate whether an investigational medication impacts heavy menstrual bleeding and other fibroid-related symptoms by blocking the effect of progesterone.

Inclusion/Exclusion Criteria:

  • Must be a premenopausal woman aged 18 years or above

  • Has abnormal heavy menstrual bleeding and/or pelvic pain.

  • Must be willing to use and collect sanitary protection (pads or tampons) provided by the Sponsor.

  • Must be willing to use a non-hormonal method of contraception 

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