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 * About Chugai


THE ACERS STUDY IS LOOKING FOR WOMEN WITH ENDOMETRIOSIS
TO INVESTIGATE A NEW POTENTIAL TREATMENT.

This is a Chugai sponsored phase 2, randomised, double-blind study evaluating
the efficacy and safety 
of an investigational product (AMY109) in women with endometriosis’



Endometriosis is a condition where tissue similar to the lining of the womb is
found elsewhere in the body. It affects 1 in 10 women in the UK1 and is a
debilitating and chronic condition which can cause painful symptoms including
heavy and painful periods, pelvic pain, painful bowl movements and in some
extreme cases scarring and damage to pelvic organs.

The ACERS study is for women with endometriosis. The study is looking to see if
a non-hormonal investigational medication (called AMY109) taken alone or with
progesterone (called desogestrel) can help reduce the severity of endometriosis.

You may be able to take part if:

 * You are female and aged between 18 and 49.
 * Have a diagnosis of endometriosis (confirmed during laparoscopic surgery).
 * Willing to have laparoscopic surgery after study treatment.


Other requirements also apply

What is Endometriosis?
Endometriosis is a condition where tissue similar to the lining of the womb is
found elsewhere in the body. It affects 1 in 10 women in the UK1 and is a
debilitating and chronic condition which can cause painful symptoms including
heavy and painful periods, pelvic pain, painful bowl movements and in some
extreme cases scarring and damage to pelvic organs.
What can I expect if I take part?

Your participation will last approximately 2 years 5 months with about 22 visits
to the study centre.
It will consist of the following parts:

Washout (if necessary) (4-12 weeks)

You may need to stop taking certain medications before you continue to
Screening.

The Screening Phase (21-45 days)
• You will visit the study centre to see if the study is suitable for you.
• You will be asked to complete questionnaires and diaries.

Randomization
You will be randomly assigned (by chance) to receive either:

 * AMY109 and desogestrel-placebo
 * AMY109 and desogestrel
 * AMY109-placebo and desogestrel


Neither you nor the study doctor will know which group you are in.


Study Treatment (approximately 1 year)

 * You will visit the study centre 14 times for assessments.
 * The treatment being tested is a non-hormonal investigational medication which
   you will receive as an intravenous (IV) infusion, which is a drip into a
   vein, every 4 weeks. The infusion will take 30 to 90 minutes.

You will also take 1 capsule of another study medication by mouth, at about the
same time every day.

Post-treatment laparoscopy

 * After you have completed the study treatment (approximately 1 year after
   starting study treatment) you will have a laparoscopy and be admitted to
   hospital for the procedure.


Follow-up period (approximately 1 year)

 * You will visit the study centre approx. 4 times for assessments

Participation in a clinical study is voluntary. You can ask any questions and
may leave the study at any time, for any reason.

Study Centre Locations

We will be running the ACERS clinical trial at the following hospitals:

 * Norfolk and Norwich University Hospital, Norwich

 * Chelsea and Westminster Hospital, London

 * Royal Hallamshire Hospital, Sheffield

 * Guy and St Thomas’, London

 * Colchester Hospital, Colchester – (not currently accepting study referrals)

Please note we are actively on-boarding new hospitals, so please check back
regularly.

Am I eligible?

C-GB-00001352 | June 2024

¹ Rogers PA, D’Hooghe TM, Fazleabas A, et al. Priorities for endometriosis
research: recommendations from an international consensus workshop. Reprod Sci
2009;16(4):335-46.

© 2024 All rights Reserved - Chugai Pharma Europe Ltd
C-GB-00001350 | June 2024

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This website is intended for potential ACERS study participants and Healthcare
Professions interested in the ACERs study.

This website is designed and intended to be viewed on a desktop or laptop
computer. 

This is a Chugai Pharmaceuticals sponsored study.
Chugai Pharma Europe Ltd, Mulliner House, Flanders Road, Turnham Green, London,
W4 1NN.


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