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A Study to Test the Safety, Tolerability, and Efficacy of an Antibody, REGN7999, Injected Under the Skin for the Treatment of Iron Overload in Adult Participants with Non-Transfusion Dependent β-thalassemia, Using MRI Scans to Measure Iron Levels in the Body.
EU CTIS ID: 2023-508604-37-00
What this study is testing
To evaluate the effect of REGN7999 on LIC. To evaluate the safety and tolerability of at least 2 different SC doses of REGN7999.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Clinical diagnosis of NTDT as described in the protocol .
- IOL, defined as LIC ≥ 5 mg Fe/g DW as measured by R2* MRI at screening.
- Serum ferritin ≥ 300 ng/mL as described in the protocol.
- Other protocol defined inclusion criteria apply.
You likely can't join if
- Hemoglobin ≤ 8 g/dL at screening.
- Any RBC transfusion within 12 weeks of visit 3.
- For Part A only: Any Iron Chelation Therapy (ICT) use in approximately 12 weeks prior to screening as described in the protocol.
- For Part B only: If on ICT, any change in ICT dose in approximately 12 weeks prior to screening as described in the protocol.
- Any use of luspatercept or mitapivat in 6 months prior to screening as described in the protocol.
- Absolute contraindication to MRI.
See the full eligibility criteria
- Clinical diagnosis of NTDT as described in the protocol .
- IOL, defined as LIC ≥ 5 mg Fe/g DW as measured by R2* MRI at screening.
- Serum ferritin ≥ 300 ng/mL as described in the protocol.
- Other protocol defined inclusion criteria apply.
- Hemoglobin ≤ 8 g/dL at screening.
- Any RBC transfusion within 12 weeks of visit 3.
- For Part A only: Any Iron Chelation Therapy (ICT) use in approximately 12 weeks prior to screening as described in the protocol.
- For Part B only: If on ICT, any change in ICT dose in approximately 12 weeks prior to screening as described in the protocol.
- Any use of luspatercept or mitapivat in 6 months prior to screening as described in the protocol.
- Absolute contraindication to MRI.
- Diagnosis of cirrhosis of the liver.
- Diagnosis of Chronic kidney disease (CKD) stage 4 or higher.
- Other protocol defined exclusion criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.