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

NCT03578497 | Completed Phase 2

• 1 other identifier: 2018-00780; me16CC6
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Polycystic Ovary Syndrome

Keywords

Interleukin-1 receptor antagonism; Kineret/Anakinra; testosteron; hyperandrogenemia; androstenedione

Outcome Measures

Primary Outcomes (1)

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

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

  7 days

Secondary Outcomes (15)

• Ferriman-Gallwey-score

  Day 1 and 28

• Sebum production measures

  At day 1 and 28

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

  At day 1 and 28

• Plewig-Kligman-score

  At day 1 and 28

• Ovulation and menstruation rates [%]

  Between day 1 and day 35

Study Arms (1)

IL-1 receptor antagonist Anakinra 100 mg

EXPERIMENTAL

Anakinra (Kineret®; r-metHuIL-1ra, Swedish Orphan Biovitrum AB) is a recombinant, non-glycosylated form of the human IL-1Ra in a 100 mg/ 0.67 ml solution for subcutaneous injection. Anakinra/Kineret® is supplied in single use prefilled glass syringes with 27 gauge needles as a sterile, clear, colorless-to-white, preservative free solution for daily s.c. administration over a time period of 28 days.

Drug: IL-1 receptor antagonist Anakinra

Interventions

IL-1 receptor antagonist Anakinra DRUG

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.

Also known as: Kineret

IL-1 receptor antagonist Anakinra 100 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,
• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel Endocrinology, Diabetes and Metabolism

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Interleukin 1 Receptor Antagonist Protein

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Mirjam Christ-Crain, Prof. Dr. MD

  University Hospital Basel, Dep. of Endocrinology, Diabetes and Metabolism

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2018
• First Posted: July 6, 2018
• Study Start: August 31, 2018
• Primary Completion: July 30, 2020
• Study Completion: July 30, 2020
• Last Updated: January 27, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)