Clinical Trials

Date: 2016-01-28

Type of information: Initiation of the trial

phase: 3

Announcement: initiation of the trial

Company: Abbvie (USA - IL) Neurocrine Biosciences (USA - CA)

Product: elagolix

Action mechanism:

GnRH receptor antagonist. Elagolix is an orally administered gonadotropin-releasing hormone (GnRH) antagonist that is currently being investigated in diseases that are mediated by sex hormones, such as uterine fibroids and endometriosis.

Disease: uterine fibroids

Therapeutic area: Women health

Country:

Trial details:

The Elagolix Phase 3 uterine fibroid clinical development program is part of AbbVie's pipeline and includes two replicate, randomized, parallel, double-blind, placebo-controlled clinical trials. Each trial is expected to enroll approximately 400 subjects for an initial six-month placebo-controlled dosing period, after which, subjects who are eligible will have an option to continue for an additional six-month dosing period in a safety and efficacy extension study.

Latest news:

• On January 28, 2016, AbbVie, in cooperation with Neurocrine Biosciences, announced the initiation of the first of two planned Phase 3 clinical studies evaluating the safety and efficacy of elagolix alone or in combination with add-back therapy compared to placebo. These studies are designed to assess the change in menstrual blood loss utilizing the alkaline hematin method, comparing baseline to month six of treatment. Additional secondary efficacy endpoints are being evaluated; including assessing changes in fibroid volume, monthly blood loss and hemoglobin levels. Bone mineral density will also be assessed.
AbbVie will make a $15 million milestone payment to Neurocrine Biosciences upon enrollment of the first patient.