SIENNA

• Research type

  Research Study

• Full title

  A Multicenter, Randomized, Double-Masked, Placebo-Controlled Phase 3 Study of the Efficacy, Safety, and Tolerability of Subcutaneously Administered Pozelimab in Combination with Cemdisiran or Cemdisiran Alone in Participants with Geographic Atrophy Secondary to Age-Related Macular Degeneration

• IRAS ID

  1010629

• Contact name

  Danise Subramaniam

• Contact email

  danise.subramaniam@regeneron.com

• Sponsor organisation

  Regeneron Pharmaceuticals Inc.

• Clinicaltrials.gov Identifier

  NCT06541704

• Research summary

  This study is designed to obtain information on the safety, tolerability and the effectiveness of two experimental drugs called pozelimab and cemdisiran when given subcutaneously (an injection under the skin) to patients with Geographic Atrophy (GA) secondary to Age-Related Macular Degeneration (AMD). In the UK, GA affects approximately 2 to 3 out of 100 individuals over the age of 65.
  GA is a progressive disease that causes permanent vision loss over time. Currently, there are no treatments available for GA in the UK. In the US, there are two approved treatments, both administered as injections into the eye. This study is being done to see if pozelimab in combination with cemdisiran or cemdisiran alone may be able to slow down progression of GA.
  Approximately 750 participants from 240 medical centres globally, are expected to take part. To participate in the study, participants must be diagnosed with GA of the macula, secondary to AMD, in one or both eyes. The study will enrol male and female participants aged 50 years of age and above.
  Participants who qualify for the study and choose to participate will be randomly assigned to receive one of the following 3 treatment combinations: pozelimab + cemdisiran, placebo + cemdisiran, or placebo + placebo. Participants will receive the study drugs once a month for about 2 years. After that, participants can choose to either: stop receiving the study drugs and move into an observation period (6 months) or continue to receive the study drugs in an open-label period for about 3 years after which they will transition to the 6-month observation period. Study procedures include: collection of medical history, vital signs, physical examination, complete ophthalmologic examination, ocular imaging, blood tests for safety monitoring and vision tests. This study is sponsored by Regeneron Pharmaceuticals, Inc.

• REC name

  HSC REC A

• REC reference

  24/NI/0124

• Date of REC Opinion

  21 Nov 2024

• REC opinion

  Further Information Favourable Opinion