Phase 4 Multiple Sclerosis Trial, Not Yet Recruiting NCT07138833 Sponsor: Qilu Pharmaceutical (Hainan) Co., Ltd. Condition: Multiple Sclerosis
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Phase 4 Multiple Sclerosis Trial, Not Yet Recruiting

NCT07138833
Not Yet Recruiting Phase 4

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 who have been diagnosed with a relapsing form of multiple sclerosis (MS) — including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), or active secondary progressive MS (SPMS) — confirmed using standard diagnostic guidelines known as the 2017 McDonald criteria.
  • People who have had at least one MS relapse (a period of new or worsening symptoms) in the 12 months before the screening visit, along with MS-related changes visible on a previous brain MRI scan, or active lesions seen on an MRI taken within 6 weeks before screening.
  • People whose level of physical disability, as measured by a standard MS scale called the EDSS, falls between 0.0 and 5.0 at the time of screening.

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 who have a history of cancer or a current cancer diagnosis — except for a type of skin cancer (basal cell carcinoma) that has been fully removed — or who have serious, uncontrolled conditions affecting major organs such as the heart, kidneys, or liver, which the trial doctor considers a significant risk or likely to interfere with study results.
  • People who have experienced an MS relapse within 30 days before screening, or whose symptoms from a previous relapse have not yet stabilised.
  • People who have attempted suicide within the past 5 years before screening, or who have experienced certain types of suicidal thoughts within 6 months before screening, as identified by a standard assessment tool; people with a history of suicidal behaviour more than 5 years before screening may require individual assessment by the trial doctor to determine eligibility (confirm with trial site).

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 2 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

If you need support right now

This page includes language about suicide and self-harm, because that is how the trial's eligibility criteria are written. If reading it has been hard, you do not have to keep going. The services below are free, confidential, and answered by people trained for exactly this.

If you or someone else is in immediate danger, call 000.

  • Lifeline — 24/7 crisis support: 13 11 14
  • Suicide Call Back Service — 24/7 counselling: 1300 659 467
  • 13YARN — 24/7, for Aboriginal and Torres Strait Islander people: 13 92 76
  • Beyond Blue — 24/7 mental health support: 1300 22 4636
  • Emergency: 000

Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention. If you are in immediate danger, call your local emergency number.

Voxsanity is not a crisis service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Not Yet Recruiting
Phase
Phase 4
Sponsor
Qilu Pharmaceutical (Hainan) Co., Ltd.
Registry
ClinicalTrials.gov
Start date
1 September 2025
Est. completion
1 April 2028

Primary endpoints

Annualized Relapse Rate at Week 48

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: 2 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