A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea

Phase 2RecruitingNCT07235917

Regeneron Pharmaceuticals34 enrolled

Overview

This study is researching an experimental drug called mibavademab (also called "study drug"). The study is focused on patients with a condition called Functional Hypothalamic Amenorrhea (FHA). FHA is a condition where a woman stops menstruating because the brain is not sending the correct hormonal signals to the ovaries, which then are not able to cycle and ovulate properly. The aim of the study is to see how well the study drug helps the body make the hormones necessary for ovulation and reproduction, and to assess its safety. The study is looking at several other research questions, including: * Whether the drug helps bone health * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Functional Hypothalamic Amenorrhea (FHA)

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: 1. Diagnosis of FHA after exclusion of anatomic or organic causes of amenorrhea 2. Has had no menstrual bleeding episode within 3 months (or longer) prior to day 1, as described in the protocol 3. Has a Body Mass Index (BMI) ≥18.5 and \<25 kg/m\^2 at screening, or BMI ≥25 to \<30 kg/m\^2 at screening AND percentage of body fat \<20% from rigorous exercise as determined by the investigator through Standard of Care (SoC) methods (eg, skinfold thickness, DXA, bioimpedance) within 6 months of screening, as described in the protocol Key Exclusion Criteria: 1. Has presence of primary amenorrhea (failure to reach menarche, first menstrual cycle) 2. Has blood estradiol ≥50 pg/mL or blood progesterone ≥1 ng/mL at screening 3. Has uterine (eg, absence of uterus, prior endometrial ablation, endometriosis, outflow tract disorders) or ovarian (eg, absence of an ovary, presence of polycystic ovaries) conditions that impact assessment of menses or of the HPO axis 4. Has conditions other than FHA that may cause amenorrhea or menstrual cycle disturbances (eg, polycystic ovarian syndrome, hyperprolactinemia, primary ovarian insufficiency, untreated primary hypothyroidism, primary hyperthyroidism) 5. Polycystic ovarian morphology with an ovarian volume \>10 cc on TransVaginal UltraSound (TVUS) \[or TransAbdominal Pelvic Ultrasound (TAPU) if applicable\] at baseline 6. Presence of follicle ≥17 mm, evidence of ruptured follicle, and/or evidence of corpus luteum on TVUS (or TAPU if applicable) at baseline NOTE: Other protocol-defined Inclusion/Exclusion criteria apply

Locations (2)

Zillan Clinical Research

Houston, Texas, United States

RECRUITING

Tidewater Clinical Research - Tidewater Physicians for Women

Norfolk, Virginia, United States

RECRUITING

Outcomes

Primary Outcomes

Change from the highest serum estradiol observed during a 28-day period

Time frame: Baseline to month 6

Secondary Outcomes

Change from the mean serum estradiol observed during a 28-day period

Time frame: Baseline to month 6

Occurrence of menses followed by mid-cycle serum estradiol ≥200 pg/ml and mid-luteal serum progesterone ≥7.9 ng/ml

Time frame: At month 6

Change in the highest serum estradiol

Time frame: Baseline through 6 months

Occurrence of serum estradiol ≥200 pg/ml

Time frame: Through 6 months

Number of ovulatory menstrual cycles

Time frame: Through 6 months

Number of menses with mid-luteal serum progesterone ≥7.9 ng/ml and midluteal estradiol ≥100 pg/ml

Time frame: Through 6 months

Number of menstrual cycles

Time frame: Through 6 months

Percent change in Bone Mineral Density (BMD) at the lumbar spine, as measured by Dual X-ray Absorptiometry (DXA)