Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT02317562) enrolled 19 participants, all in a single group called the "I10E Arm." The trial was measuring a "responder rate" at the end of the study — that is, how many participants met certain criteria related to their disability score (a standard scale used to track how a nerve condition called CIDP affects daily functioning) and whether their treatment needed to be changed. Of the 19 people who started, only 5 completed the study, while 14 did not finish. The reported data shows that 15 out of 19 participants were counted as "responders" based on the study's definition — meaning their disability score either stayed the same, decreased, or increased by only 1 point, without needing a change in their CIDP treatment. However, the study's own documentation notes that this trial was ended earlier than planned, and a large number of participants left before it was finished. Because of this, the researchers stated that the responder rate figure is biased and, in their words, "not interpretable." This means the number should be treated with significant caution. The reported data should therefore be understood in that context — the early termination and high dropout rate mean the primary result cannot be reliably understood from this trial alone. No secondary outcome data appears to have been reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Rare Disease Trial, Terminated
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You are 18 years of age or older (male or female)
- You took part in the previous related study called PRISM I10E-1302 and showed improvement — specifically, your disability score improved by at least 1 point by the end of that study
- You are covered by a national health insurance system, as required in your country
- You are willing and able to give written consent before any study procedures begin
Who may not be able to join:
- You have had a severe allergic reaction to any immunoglobulin (Ig) treatment in the past
- You have a known allergy to human immunoglobulin or to glycine or polysorbate 80 (ingredients in the study treatment)
- You have a history of serious heart problems, uncontrolled irregular heartbeat, unstable heart disease, or uncontrolled high blood pressure
- You have a history of blood clots in the veins, a heart attack, or a stroke
- You have a condition that makes your blood abnormally thick, such as certain blood or immune disorders (confirm with trial site)
- Your body mass index (BMI) is 40 or above
- Your kidneys are not working well enough, based on a specific kidney function test (confirm with trial site)
- You have another ongoing condition that can cause nerve damage, such as uncontrolled diabetes, HIV, hepatitis B or C, certain cancers, lupus, or an inherited nerve condition, among others
- You are pregnant, breastfeeding, or a woman who could become pregnant and is not using effective contraception
- You have any other serious medical condition that could interfere with the study or make it unsafe for you to participate
- You have recently started or increased a steroid medication (above a low daily dose) in the last 3 months — skin-applied steroids are allowed
- You have been treated with certain immune-suppressing or immune-modifying medicines, or had a stem cell transplant, within the past 12 months
- You have had plasma exchange or received blood products within the last 3 months
- There are concerns that you may have difficulty following the study requirements
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
GP referral letter
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Trial details
Where this trial is recruiting
Primary endpoints
Efficacy Endpoint : Responder Rate at End of Study (EOS) Visit
Can't join this trial?
Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.