APOLLO
Research type
Research Study
Full title
APOLLO: A Randomized, Double-Blind, Placebo-Controlled Study of Bitopertin to Evaluate the Efficacy, Safety, and Tolerability in Participants with Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP)
IRAS ID
1011700
Contact name
Melanie Chin
Contact email
Sponsor organisation
Disc Medicine, Inc.
Clinicaltrials.gov Identifier
Research summary
The APOLLO study is designed to see if an investigational medication called bitopertin can help people with erythropoietic protoporphyria (EPP) or X-linked protoporphyria (XLP). Specifically, this includes testing if taking bitopertin increases how long people with EPP or XLP can tolarate sun exposure without experiencing pain. Bitopertin acts to lower the amount of a chemical called glycine inside cells in the body, which in turn lowers the levels of protoporphyrin IX. The amount of protoporphyrin IX in participants’ blood will be measured during the study. The study will also look at how well people feel while taking bitopertin and if they develop any side effects from bitopertin. This study will use placebo (medication which looks the same as bitopertin but does not contain any active substance) to compare the effects with bitopertin. Participants will have the same chance (50%) of being given placebo or bitopertin.
The study will include about 150 participants aged 12 years and older at approximately 30 study clinics in multiple countries. Subject participation will last approximately 8 months which will include screening, treatment period and follow-up treatment.
Patients will be required to attend clinic/hospital visits whereby study procedures will be performed. Bitopertin is an investigational medication, meaning that it has not been approved by governmental agencies in any country, including United Kingdom, to treat any condition, so it may cause side effects that are not known at this time. Patients will be monitored throughout the study; participation is
voluntary and informed consent is mandatory.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
25/NW/0193
Date of REC Opinion
7 Aug 2025
REC opinion
Further Information Favourable Opinion