Phase 2 Crohn's Disease and Colitis Trial, By Invitation
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not 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 may be able to join
- People with Crohn's Disease (CD) who completed the full course of double-blinded treatment at Week 52 of a related study called SPECIFI-CD (DRI18212).
- People with Crohn's Disease who completed open-label treatment and reached the required health outcomes at Week 52 of the SPECIFI-CD (DRI18212) study.
- People with ulcerative colitis (UC) who completed the full course of double-blinded treatment at Week 52 of a related study called SPECIFI-UC (DRI17822).
- People with ulcerative colitis who completed open-label treatment and reached the required health outcomes at Week 52 of the SPECIFI-UC (DRI17822) study.
- People who use contraception in a way that meets local regulations for clinical trial participants, and women who are neither pregnant nor breastfeeding.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People with Crohn's Disease who have developed a new health condition that would prevent participation, as defined in the exclusion criteria of the SPECIFI-CD (DRI18212) study protocol.
- People with ulcerative colitis who have developed a new health condition that would prevent participation, as defined in the exclusion criteria of the SPECIFI-UC (DRI17822) study protocol.
- People who have developed a new health condition, or a significant change in an existing health condition, that the trial doctor believes would negatively affect their participation or would require them to permanently stop taking the trial medication.
- People who permanently stopped taking the trial medication during the earlier related study, or who stopped taking it for more than 14 days in a row before the start date of this study.
- People who experienced a side effect or serious side effect during the earlier related study that was linked to the study drug balinatunfib, and where the trial doctor believes continuing treatment could pose an unreasonable risk to that person.
- People who did not consistently follow the medication schedule or standard treatments for Crohn's Disease or ulcerative colitis during the earlier related study, or who took a medication that was not permitted alongside the trial medication.
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
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Number of participants with Crohn's Disease with treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESIs); Number of participants with ulcerative colitis with treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESIs)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 1 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.