Phase 2 Castleman Disease Trial, Completed NCT01400503 Sponsor: Janssen Research & Development, LLC Condition: Castleman Disease
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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 enrolled 60 participants, all of whom received a medicine called siltuximab. The trial was a long-term safety extension study, meaning its main purpose was to track unwanted medical events (called adverse events) that occurred while participants were receiving the treatment. The reported data shows that none of the 60 participants were recorded as having "completed" the study in the usual sense — all 60 were listed under "not completed," which may reflect the nature of a long-term extension study, though no further explanation for this was provided in the data. The reported data shows that all 60 participants experienced at least one adverse event during the study. For the secondary measures, the results were broken into two groups: participants who had previously responded to siltuximab before joining this extension, and those who were new to the medicine. Among those who had previously responded, 96.5% were reported to have maintained what the study called "disease control" (meaning their condition stayed stable or improved, as judged by their doctor). Among those who were new to siltuximab, 100% were reported to have experienced disease control during the study. Additionally, 3 out of 60 participants were found to have developed antibodies to siltuximab (proteins the body can produce in response to a medicine). Two other measures — how long disease control lasted and overall survival — were listed but no figures were reported in the data submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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 2 Castleman Disease Trial, Completed

NCT01400503
Completed Phase 2

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 have been diagnosed with multicentric Castleman's disease (a rare condition affecting the lymph nodes)
  • You previously took part in one of two specific earlier studies (called C0328T03 or CNTO328MCD2001), in either the treatment or comparison group
  • Your last dose of study treatment (either the study drug siltuximab or a dummy/placebo treatment) was given less than 6 weeks ago (up to 8 weeks may be acceptable — confirm with trial site)
  • Your disease did not get worse while you were receiving the study drug siltuximab; or if you were originally in the placebo group and later switched to siltuximab, you received it for less than 4 months
  • Your recent blood test and lab results (taken within the last 2 weeks) are at acceptable levels (confirm with trial site)

Who may not be able to join:

  • You stopped the previous study because of serious side effects that could not be managed, a bad reaction, your disease getting worse, or because you chose to withdraw
  • You have received a live vaccine (such as certain flu, MMR, or chickenpox vaccines) within the last 4 weeks
  • You have known serious allergies or reactions to certain types of medicines called monoclonal antibodies, or to proteins derived from mice or humans, or to related ingredients

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

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Trial details

Status
Completed
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
1 April 2011
Est. completion
1 March 2017

Where this trial is recruiting

🇧🇪 Belgium 🇧🇷 Brazil 🇨🇦 Canada 🇨🇳 China 🇪🇬 Egypt 🇫🇷 France 🇩🇪 Germany Hong Kong 🇮🇱 Israel 🇳🇿 New Zealand 🇳🇴 Norway 🇸🇬 Singapore 🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Number of Participants With Adverse Events (AEs)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov