Are you living with chronic inflammatory demyelinating polyneuropathy (CIDP)?
If you have been diagnosed with CIDP and have a documented history of a significant disability and weakness of at least 2 limbs, you may be eligible to participate in the KB071 Study.
Learn more.
The KB071 Study is evaluating the safety and effectiveness of an investigational intravenous immunoglobulin (IVIg) medicine for use as a maintenance therapy to see if it can help control Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) symptoms and improve participants’ quality of life.
About CIDP
Chronic inflammatory demyelinating polyneuropathy (CIDP) is a neurological disorder, which usually causes progressive weakness, sensory loss, and impaired motor function, particularly in the legs and arms. It is either chronic progressive or relapsing and remitting disease. It is caused by inflammation of the peripheral nervous system that damages the myelin sheaths that insulate nerve fibers.
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.
You may be able to join the KB071 Study if you:
- Are 18 years or older
- Have been diagnosed with CIDP
- Are being treated with immunoglobulins, corticosteroids, or other standard-of-care treatments for CIDP
- Have a documented history of a significant disability and weakness of at least 2 limbs
Taking part in the KB071 Study includes:
Screening period:
Up to 4 weeks.
Washout phase:
12 weeks
Randomization phase:
24 weeks
Follow-up:
4 weeks after the last dose of the study medicine
After screening to determine whether you qualify, you will gradually reduce your current CIDP medications over 12 weeks. After this washout period, you will then be randomized (like the flip of a coin) to receive one of two doses of the study medicine:
Lower dose (0.5 g/kg)
Higher dose (1.0 g/kg)
The study medicine is given through a vein in an arm every 3 weeks for 21 weeks. There is no placebo, so all participants will receive one of the two dose levels. Participants will be closely monitored for worsening symptoms throughout the study, and those who relapse during the treatment period will receive a rescue dose (2.0 g/kg of KIg10). You will then have a follow-up visit 4 weeks after the last dose of the study medicine.
Find a study center
Please enter your city or your ZIP code / postal code to find a study center near you.
Please select the study center that is most convenient for you.
Please answer this brief questionnaire to see if you may qualify for the KB071 Study for patients living with CIDP.
A clinical research study (also called a trial) is carefully supervised research that is done before an investigational drug can be made available to the public. The results help researchers and government officials decide if a drug works, is safe, and should be available to patients. Studies are the only way to bring about new treatments to improve patient care.
Frequently asked questions
The KB071 Study is evaluating the safety and effectiveness of an investigational intravenous immunoglobulin (IVIg) medicine for use as a maintenance therapy to see if it can help control CIDP symptoms and improve participants’ quality of life.
Taking part in the KB071 Study includes:
- Screening period: Up to 4 weeks
- Washout phase: 12 weeks
- Randomization phase: 24 weeks
- Follow-up: 4 weeks after the last dose of the study medicine
After screening to determine whether you qualify, you will gradually reduce your current CIDP medications over 12 weeks. After this washout period, you will then be randomized (like the flip of a coin) to receive one of two doses of the study medicine every 3 weeks for 21 weeks. The study medicine is given through a vein in an arm.
You will then have a follow-up visit 4 weeks after the last dose of the study medicine.
Participation in any clinical study is completely voluntary. Joining the KB071 Study is completely up to you. Deciding not to take part will not affect your usual medical care now or in the future. If you do take part, you can leave the study at any time and for any reason.
During a clinical study, you may receive the medication that is being studied. This will be done at scheduled times and may occur only once or multiple times throughout the study, depending on the medication. If you participate, you may also have the following procedures performed to monitor your health: vital signs, blood work, physical exams or other types of assessments that are necessary to gather the required information about the study medication.
There are many reasons to participate in clinical research. For starters, it allows participants to play a more proactive role in their own health by receiving a new treatment for an ongoing disease or condition. Participants also play an important part in potentially bringing much-needed drugs to market, which may benefit others who also have the disease or condition.
Every clinical trial must be reviewed, and is continually monitored, by a regulatory review committee to ensure the risks are as low as possible and are worth any potential benefits to the study participant. As a study participant, you have the right to discontinue your participation and leave the study at any time and for any reason, with no penalty or loss of benefits to which you are otherwise entitled to.
Kedrion S.p.A.is responsible for conducting this clinical study.
