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Polycystic Ovary SyndromePhase 2FertILNCT03578497

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

A Phase 2 study testing IL-1 receptor antagonist Anakinra in people with Polycystic Ovary Syndrome, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Polycystic Ovary Syndrome
What is being tested?
IL-1 receptor antagonist Anakinra
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteSwitzerland
Study dates
31 Aug 2018to 30 Jul 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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,
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  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • University Hospital Basel Endocrinology, Diabetes and Metabolism

    Basel, 4031

Other trials in Switzerland

About this study

Official title: Effects of Interleukin-1 Receptor Antagonism on Hyperandrogenemia in Women With Polycystic Ovary Syndrome - a Prospective, Interventional, Single-arm, Open-label, Proof-of-concept Study

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.

Being tested
IL-1 receptor antagonist Anakinra
Keywords
Interleukin-1 receptor antagonism, Kineret/Anakinra, testosteron, hyperandrogenemia, androstenedione
Medical subject headings
Polycystic Ovary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IL-1 receptor antagonist AnakinraDrug

    Also called Kineret

    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.

Study groups in NCT03578497
Study groupRoleWhat they receive
IL-1 receptor antagonist Anakinra 100 mgExperimentalAnakinra (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.
Receives: Drug: IL-1 receptor antagonist Anakinra

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 7 days

Secondary outcomes (15)

  1. 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

    Measured: Day 1 and 28

  2. 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)

    Measured: At day 1 and 28

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

    Effect of Anakinra/Kineret® on hirsutism will be assessed

    Measured: At day 1 and 28

  4. 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.

    Measured: At day 1 and 28

  5. Ovulation and menstruation rates [%]

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

    Measured: Between day 1 and day 35

  6. Estradiol (pmol/l), free testosterone (nmol/l), total testosterone (nmol/l), sex hormone-binding globulin (SHBG) [nmol/l], Anti-Muellerian Hormone [pmol/l], dehydroepiandrosterone (DHEA) [nmol/l]), basal cortisol (nmol/l)

    Effect of Anakinra/Kineret® on peripheral (sexual) hormones will be assessed

    Measured: Day 1, 7, 14, 21, 28 and 35

  7. Fasting glucose (mmol/l), homeostatic model of assessment of insulin resistance (HOMA-IR)

    Effect of Anakinra/Kineret® on glucose metabolism will be assessed

    Measured: At day 1, 7, 14, 21, 28 and 35

  8. Pituitary hormones (luteinizing hormone (LH), follicle stimulating hormone (FSH), adrenocorticotropic hormone (ACTH) [IU/L])

    Effect of Anakinra/Kineret® on the pituitary-gonadal axis will be assessed

    Measured: Day 1, 7, 14, 21, 28 and 35

  9. Treatment response according to a Dexamethasone suppression test

    Dexamethasone suppression test will be evaluated as a predictor for treatment response

    Measured: At days 35 and 36

  10. inflammatory marker white blood cell count [x109/l],

    Time course of inflammatory marker white blood cell count [x109/l] will be assessed

    Measured: Day 1, 7, 14, 21, 28 and 35

  11. inflammatory marker C reactive protein (CRP) [mg/l]

    Time course of inflammatory marker CRP [mg/l] will be assessed

    Measured: Day 1, 7, 14, 21, 28 and 35

  12. inflammatory marker IL-6 [pg/ml]

    Time course of inflammatory marker IL-6 [pg/ml] will be assessed

    Measured: Day 1 and 28

  13. inflammatory marker IL-1Ra [pg/ml]

    Time course of inflammatory marker IL-1Ra [pg/ml] will be assessed

    Measured: Day 1, 7, 14, 21, 28 and 35

  14. Change in androstenedione level (nmol/l) from start (baseline, day 1) to days 14, 21, 28, and 35 after treatment start with Anakinra.

    Change in androstenedione level (nmol/l) from start (baseline, day 1) to days 14, 21, 28, and 35 after treatment start with Anakinra.

    Measured: Days 14, 21, 28, and 35 after treatment start with Anakinra

  15. Change in 11-oxygenated androgens (e.g. 11-ketotestosterone, 11-ketoandrostenedione, 11β-hydroxytestosterone, 11β-hydroxyandrostenedione [nmol/l]) on days 7, 14, 28, and 35 after treatment start with Anakinra

    Change in 11-oxygenated androgens (e.g. 11-ketotestosterone, 11-ketoandrostenedione, 11β-hydroxytestosterone, 11β-hydroxyandrostenedione [nmol/l]) on days 7, 14, 28, and 35 after treatment start with Anakinra

    Measured: Days 7, 14, 28, and 35 after treatment start with Anakinra

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2018
  2. Study start31 Aug 2018
  3. Primary completion30 Jul 2020
  4. Study completion30 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03578497
Sponsor's protocol ID
2018-00780; me16CC6
Other IDs
2018
Acronym
FertIL
Status last verified
Jan 2021
First submitted
21 Jun 2018
Last updated
27 Jan 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IL-1 receptor antagonist Anakinra in people with Polycystic Ovary Syndrome, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03578497.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.

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