New drug B001 tested for rare autoimmune disease
NCT ID NCT05145361
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This early-phase trial tests a new drug called B001 in 45 people with a rare autoimmune disease called NMOSD. The study aims to check if B001 is safe, how the body processes it, and whether it might help control the disease. Participants must have had at least one relapse in the past year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- B001 injection
- What this could lead to
- If successful, this could point toward a new treatment option to control NMOSD and reduce relapses.
- What could go wrong
- This is a very early, small Phase 1b trial focused on safety and dosing. It may not show clear benefit, and side effects are unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2022
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. NMOSD as defined by either of the following 2015 criteria with anti-AQP4 antibody (Ab) seropositive status at screening 2. Clinical evidence of at least 1 documented relapse in last 12 months prior to screening 3. Expanded Disability Status Scale (EDSS) score from 0 to 7.5 inclusive at screening 4. Age 18 to 70 years, inclusive at the time of informed consent Exclusion Criteria: 1. Any previous treatment with anti-CD20, eculizumab, anti-BLyS monoclonal antibody (e.g., belimumab), any other treatment for prevention of multiple sclerosis (MS) relapse (e.g., interferon, natalizumab, glatiramer acetate, fingolimod, teriflunomide or dimethyl fumarate) within 6 months prior to baseline. 2. Received immunosuppression such as azathioprine, mycophenolate mofetil, methotrexate, cyclophosphamide, tacrolimus, mitoxantrone, cyclosporine A, etc, and rug therapy, biological agents such as satralizumab, tocilizumab, eculizumab, etc, 3 months prior to the first administration. 3. Evidence of serious uncontrolled concomitant diseases that may preclude participant participation, as described; Other nervous system disease, cardiovascular disease, hematologic/hematopoiesis disease, respiratory disease, muscular disease, endocrine disease, renal/urologic disease, digestive system disease, congenital or acquired severe immunodeficiency. 4. Known active infection within 3 months prior to baseline 5. Pregnancy or lactation. 6. History of severe allergic reaction to a biologic agent 7. Evidence of chronic active hepatitis B or C 8. Evidence of active tuberculosis 9. Following laboratory abnormalities at screening\*: 1. White blood cells (WBC) \<4.0 x10\^3/microliter (μL) 2. Absolute neutrophil count (ANC) 3. Absolute lymphocyte count \<0.5 x10\^3/μL 4. Platelet count \<80 x 10\^9/ L 5. Aspartate aminotransferase (AST) or alanine aminotransferase 10. History of drug or alcohol abuse within 6 months prior to baseline 11. Receipt of any live or live attenuated vaccine within 4 weeks prior to baseline 12. Uncontrolled systemic diseases, including hypertension that cannot be effectively controlled after treatment (systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥100 mmHg), diabetes, gastrointestinal diseases, etc.; or the investigator believes that there is anything inappropriate reasons for selection.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing Tiantan Hospital Capital Medical University
RECRUITINGBeijing, Beijing Municipality, 100050, China
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First Hospital of Shanxi Medical University
RECRUITINGTaiyuan, Shanxi, 030001, China
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Tangdu hospital,fourth military medical university
RECRUITINGXi’an, Shanxi, 710038, China
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Tianjin Medical University General Hospital
RECRUITINGTianjin, Tianjin Municipality, 300052, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a JAK inhibitor tame the immune attack in NMOSD?
- New study uses advanced scans to map brain inflammation over time
- Immune cell therapy aimed at autoimmune diseases hits early snag
- Could zapping the brain ease nerve pain in NMOSD?
- Massive Real-World study to track brain and nerve autoimmune disorders
- AI set to revolutionize MS diagnosis and monitoring