Kedrion’s 10% IVIG study
ABOUT THE KB071 STUDY
The KB071 Study is testing the safety and clinical benefit of a new intravenous immunoglobulin (IVIg) therapy to see what, if any, benefit it may have on your condition. After screening, eligible participants will gradually reduce their pre-study CIDP medication for up to 12 weeks (this is called a washout period). After this washout period, participants will then be randomly assigned (like the flip of a coin) to receive 1 of 2 doses of the study medicine every 3 weeks for 24 weeks. The study medicine is given intravenously through a vein in an arm. Participants will then have a follow-up visit at least one week later.
STUDY DURATION
Participation in the KB071 Study lasts 41 weeks and includes:
- Screening: Up to 4 weeks
- Washout period: 12 weeks
- Treatment period: 21 weeks
- End of Study – Week 24
- Follow-up (Week 25): 4 weeks after the last dose of the study medicine
WHO CAN JOIN THE KB071 STUDY?
You may be able to join if you:
- Are 18 years or older
- Have been diagnosed with CIDP
- Are being treated with immuno-globulins, corticosteroids, or other standard-of-care treatments for CIDP
- Have weakness in at least 2 limbs
WHY TAKE PART?
Participants may receive:
- Access to an investigational medicine (immune globulin intravenous 10% solution) a type of intravenous immune globulin or IVIG
- Close care and monitoring from a neurologist
- Driver services for those who need it, and participants may bring one caregiver for support
LEARN MORE:
If you’d like more information about the KB071 Study, scan this QR code below, or contact us at https://cidpstudy.com/ or clinicaltrials.gov/study/NCT067523561
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