Effects of Interleukin-1 Receptor Antagonism on Hyperandrogenemia in Women With Polycystic Ovary Syndrome

University Hospital, Basel, Switzerland18 enrolled

Overview

A prospective, interventional, open-label, single-arm, proof-of-concept study: 18 women with Polycystic Ovary Syndrome (PCOS) will be treated with 100 mg of Anakinra/Kineret® for 4 weeks. 1 week after last injection patients will have a follow-up and a dexamethasone visit after a dexamethasone suppression test. Goal of this study is to investigate the effect of the Interleukin 1( IL-1) receptor antagonist Anakinra/Kineret® on laboratory and clinical features in women with PCOS.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Polycystic Ovary Syndrome

Interventions

IL-1 receptor antagonist AnakinraDRUG

IL-1 receptor antagonist Anakinra is a recombinant, non-glycosylated form of the human IL-1Ra in a 100 mg/ 0.67 ml solution for subcutaneous injection. Standard dosage licensed by the FDA and European Medicines Agency (EMA) is 100 mg Anakinra daily. It is supplied in single use prefilled glass syringes with 27 gauge needles as a sterile, clear, colourless-to-white, preservative free solution for daily s.c. administration.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Informed Consent as documented by signature * Premenopausal women aged 18 years or older * Onset of menarche ≥5 years ago * Diagnosis of PCOS defined by the Rotterdam criteria * High sensitivity C-reactive protein level ≥1 mg/l * Follicular phase of menstrual cycle as evident by * Serum estradiol level \<200 pmol/l AND * Serum progesterone level \<8 ng/ml * Willingness to use non-hormonal contraceptive measures adequate to prevent becoming pregnant during the study Exclusion Criteria: * Intake of any testosterone level modifying drugs in the 8 weeks prior to study inclusion, * Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to Anakinra/Kineret, * Women who are pregnant or breast feeding, * Female participants who are ovariectomized or hysterectomised or post-menopausal * Known or suspected non-compliance, drug or alcohol abuse, * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant, * Participation in another study with investigational drug within the 30 days preceding and during the present study, * Previous enrolment into the current study, * Enrolment of the investigator, his/her family members, employees and other dependent persons, * Clinical signs of infection in the week before inclusion or history of a severe infection during the last 2 months, * Potentially severe immunosuppression or intake of other immunosuppressive drugs * Severe hematologic disease * Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, active carcinoma), * History of or suspected tuberculosis and/or hepatitis B/C

Locations (1)

University Hospital Basel Endocrinology, Diabetes and Metabolism

Basel, Switzerland

Outcomes

Primary Outcomes

Absolute change in fasting serum androstenedione level (nmol/l) from start (baseline, day 1) to one week after treatment start with Anakinra.

Time frame: 7 days

Secondary Outcomes

Ferriman-Gallwey-score

Effect of Anakinra/Kineret® on hirsutism by Ferriman-Gallwey-score (representation of hair growth in a male pattern on a woman shown in four different degrees of severity ( 0= no hair growth; 1= light hair growth; 2= moderate hair growth; 4= severe hair growth) in 11 different body parts; namely the upper lip, chin, chest, upper back, lower back, upper abdomen, lower abdomen, arm, forearm, thigh, and lower leg) will be assessed

Time frame: Day 1 and 28

Sebum production measures

Effect of Anakinra/Kineret® on sebum production will be assessed with Sebumeter® SM 815, Courage + Khazaka electronic Gesellschaft mit beschränkter Haftung (GmbH)

Time frame: At day 1 and 28

Self-reported frequency of hair removal (times/week)

Effect of Anakinra/Kineret® on hirsutism will be assessed

Time frame: At day 1 and 28

Plewig-Kligman-score

Effect of Anakinra/Kineret® on acne severity, assessed with Plewig-Kligman score (presentation of comedonal and inflammatory acne severity, separately graded based on the number of lesions and type; lesion counting done at right side of the face, excluding other side, chest and back.

Time frame: At day 1 and 28

Ovulation and menstruation rates [%]

Effect of Anakinra/Kineret® on ovulation and menstruation rates will be assessed

Data from ClinicalTrials.gov

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