CAPTIVATE: A Clinical Trial for Patients with CIDP
What is this trial about?
The CAPTIVATE study is testing a new medicine called DNTH103 to see if it can help people with CIDP (Chronic Inflammatory Demyelinating Polyneuropathy).
What is CIDP?
CIDP is a rare condition where your body’s defense system (immune system) mistakenly attacks the protective covering around your nerves. This can cause:
- Weakness in your arms and legs
- Numbness and tingling feelings
- Problems with balance and walking
About the new medicine being tested
The new medicine (DNTH103) works by blocking a specific protein (activated C1s) in your body that may be causing nerve damage. By only blocking activated C1s proteins, DNTH103 aims to reduce nerve damage while still allowing other parts of your immune system to fight infections.
How you’ll receive the medicine:
- First time: Through a needle in your vein (like an IV)
- After that: As an injection under your skin every 2 weeks
Patient-friendly features of this trial
- Everyone starts with the actual medicine (not a placebo/sugar pill)
- Safety first approach: If the medicine doesn’t help you in the first part of the trial, you won’t have to try the placebo and can return to your regular CIDP treatment.
- Works with your current treatments:
- If you’re currently getting immunoglobulin treatments (also called IVIg or SCIg), you can stay on them until 1 week before starting the trial medicine
- If you’re taking a low dose of steroids that’s working for you, you can continue taking them throughout the trial
How the trial works – Step by Step
- Check if you qualify: The study doctor will do some tests
- First treatment period (up to 13 weeks): Everyone gets the new medicine
- Second treatment period (up to 53 weeks): If your symptoms improve in the first period, you’ll receive either the new medicine or a placebo (a look-alike with no active medicine)
- Optional extension (up to 103 weeks): Everyone receives the new medicine
- Follow-up period (up to 40 weeks): Regular check-ups after treatment ends
Can I join this trial?
You might be able to join if you:
- Are between 18 and 75 years old
- Have been diagnosed with CIDP
- Have one of these treatment situations:
- You’re currently using CIDP treatments like immunoglobulins (Igs) or steroids and they’re helping
- You responded to standard CIDP treatments before but aren’t getting them now
- You tried standard treatments for at least 12 weeks but didn’t get better
- You couldn’t tolerate standard treatments because of side effects
- You’ve never received treatment for your CIDP
What happens during study visits?
- Most visits take about 3 hours
- You’ll have:
- Blood tests
- Physical check-ups
- Tests to measure your nerve function and strength
- Questions about how you’re feeling
Where allowed by local regulations:
- Transportation help may be available
- Some visits might be done at your home
Is there any cost to join?
All study-related medical care is provided at no cost to you, including:
- Study-related exams
- Study medication
- Study-related procedures
No insurance is required to participate.
Where regulations permit:
- Transportation support and reimbursement may be available for patients and caregivers
- Some visits may be conducted at home
Want to learn more?
If you’re interested in learning more about the CAPTIVATE trial, please email us at clinicaltrials@dianthustx.com or speak with your healthcare provider about whether this trial might be right for you.
For more information on this trial, download the flyer here.