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Neuromyelitis Optica Spectrum DisorderNCT05284175

A Study of Orelabrutinib in Patients With AQP4-IgG Positive Neuromyelitis Optica Spectrum Disorder

A study testing Orelabrutinib in people with Neuromyelitis Optica Spectrum Disorder, run by Peking Union Medical College Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Neuromyelitis optica spectrum disorder (NMOSD) is a chronic inflammatory demyelinating autoimmune disease of the central nervous system. NMOSD is a highly relapsing, severely disabling disease. AQP4-IgG positive NMOSD is related to a specific aquaporin 4 antibody (AQP4 IgG) produced by mature B cells. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Neuromyelitis Optica Spectrum Disorder
What is being tested?
Orelabrutinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteChina
Study dates
Apr 2022to Aug 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1) 18-75 years old (inclusive) at the time of signing the informed consent form
  • 2)Diagnosed with AQP4-IgG positive NMOSD in accordance with 2015 IPND diagnostic criteria.
  • 3)Relapse ≥ 2 within 1 year before screening, and at least 1 relapse within 6 months before screening
  • 4)If the subject has stable steroids treatment (≤ 7.5mg prednisone, or equivalent dose of steroids), the treatment needs to be stable more than 1 month before starting the study drug treatment.
  • 5)EDSS ≤7.5 at screening
  • 6)Negative pregnancy test for female of childbearing potential at screening
  • 7)Understood the study procedure and voluntarily signed written informed consent

Who cannot join

  • 1) History of serious heart, lung, liver, kidney, blood disease, etc.
  • 2) Any major infection judged by the investigator requiring hospitalization and parenteral antimicrobial treatment within 1 month before screening
  • 3) History of episodes of herpes zoster ≥ 2 or disseminated herpes zoster ≥ 1
  • 4) History of or having any of the following medication / treatment: ① Received BTK inhibitor at any time in the past; ② B-cell targeted therapy within 12 weeks before the first dose; ③ Received biological agents within 12 weeks before the first dose; ④ Received live virus vaccine or live attenuated vaccine within 8 weeks before the first dose; ⑤ Received steroids treatment for other diseases within 6 months before screening, the dosage > 20mg / day for more than 21 days; ⑥ Used a study drug or other experimental treatment within 4 weeks before screening or 5 half-lives, or participating in any other intervention clinical trial.
  • 5) During screening or baseline examination, laboratory results meet the exclusion criteria:
  • Human immunodeficiency virus (HIV) positive
Show all 15Show fewer
  • Hepatitis C virus (HCV) antibody positive. (If a subject has a history of HCV infection, has completed and recorded appropriate treatment at least 1 year before screening, and the HCV RNA measured by PCR at the time of screening is negative, the subject will not be excluded from this study.)
  • Hepatitis B surface antigen (HBsAg) positive and / or hepatitis B core antibody (HBcAb) positive
  • Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2
  • ALT/AST > 2 x ULN, Total Bilirubin > 1.5 x ULN, or any other clinically significant laboratory abnormality
  • Neutrophil < 1500 / mm3, platelet < 75000 / mm3, lymphocyte < 1000 / mm3 or leukocyte < 3500 / mm3.
  • International standardized ratio (INR) ≥ 1.5 or activated partial thromboplastin time (APTT) ≥ 1.5x ULN.
  • CD19 B cells lower than the lower limit of the normal range
  • 6) Used strong to medium CYP3A inducers within 3 weeks before treatment, or strong to medium CYP3A inhibitors within 1 week before treatment, or strong to medium CYP3A inducers or inhibitors may be used during treatment.
  • 7) There are situations that other researchers think are not suitable to participate in this study.

Trial locations and contacts

1 site in 1 country.

Yan Xu, Doctor contact

18601355218

xuyanpumch@hotmail.com

China1 site

  • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100730

    Yan Xu, Dr., 18601355218, xuyanpumch@hotmail.com

Other trials in China

About this study

Official title: A Prospective, Self-controlled Study to Explore Efficacy and Safety of Orelabrutinib in AQP4-IgG Positive Neuromyelitis Optica Spectrum Disorder

Neuromyelitis optica spectrum disorder (NMOSD) is a chronic inflammatory demyelinating autoimmune disease of the central nervous system. NMOSD is a highly relapsing, severely disabling disease. AQP4-IgG positive NMOSD is related to a specific aquaporin 4 antibody (AQP4 IgG) produced by mature B cells. BTK is a key kinase in B cell receptor signal transduction pathway. Abnormal activation of BTK related signaling pathway can lead to autoantibody production and autoimmune diseases. Therefore, BTK can be developed as a new target for autoimmune diseases.

Read the detailed description

Approximately 23 subjects will be enrolled.

Experimental drug treatment: Orelabrutinib, 50mg, orally, once a day.

The subject will come to visit at week 0, 1, 2, 4, 8, 12, 16, 20, 24, 36, 48 and safety follow up visit which is planed 28 days after last administration.

Baseline patient assessment:

  1. Baseline examination: vital signs, physical examination, blood routine examination, urine routine examination, liver and kidney function, coagulation function, thyroid function, HIV, HCV, HBV virus test, tuberculosis test, chest X-ray, ECG and pregnancy test.
  2. Functional disability assessment: Expanded Disability Status Scale (EDSS) score and low contrast vision (LCVA) score.
  3. EQ5D scale evaluation.
  4. Serum AQP4-IgG titer, neuro filament light chain, T/B/NK cell count, Immunoglobulin (IgG, IgA and IgM)
Being tested
Orelabrutinib
Keywords
Neuromyelitis Optica Spectrum Disorder, BTK inhibitors, Orelabrutinib
Medical subject headings
Neuromyelitis Optica

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OrelabrutinibDrug

    Orelabrutinib, orally, 50 mg QD

Study groups in NCT05284175
Study groupRoleWhat they receive
Orelabrutinib, orally, 50 mg QDExperimentalOrelabrutinib, orally, 50 mg QD
Receives: Drug: Orelabrutinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Annualized relapse rate at week 48 compared with that before baseline.

    Annualized relapse rate at week 48 compared with that before baseline.

    Measured: week 48

Secondary outcomes (7)

  1. Proportion of patients without relapse

    Proportion of patients without relapse at weeks 24 and 48;

    Measured: weeks 24 and 48

  2. Changes in the expanded disability status scale (EDSS) score from baseline

    Changes in the expanded disability status scale (EDSS) score from baseline at weeks 4, 12, 24, 36 and 48;

    Measured: weeks 4, 12, 24, 36 and 48

  3. Changes in low contrast visual acuity score (LCVA) from baseline

    Changes in low contrast visual acuity score (LCVA) from baseline at weeks 4, 12, 24, 36 and 48;

    Measured: weeks 4, 12, 24, 36 and 48

  4. Changes in EQ5D scores from baseline

    Changes in EQ5D scores from baseline at weeks 12, 24, 36 and 48;

    Measured: weeks 12, 24, 36 and 48

  5. Changes in serum AQP4-IgG titer and neurofilament light chain protein level from baseline

    Changes in serum AQP4-IgG titer and neurofilament light chain protein level from baseline at weeks 4, 12, 24, 36 and 48;

    Measured: weeks 4, 12, 24, 36 and 48

  6. Changes in absolute value of peripheral blood B cell count and immunoglobulin (IgA, IgM, IgG) from baseline

    Changes in absolute value of peripheral blood B cell count and immunoglobulin (IgA, IgM, IgG) at weeks 4, 12, 24, 36 and 48 from baseline;

    Measured: weeks 4, 12, 24, 36 and 48

  7. Percentage of patients who withdraw from the study due to adverse events.

    Percentage of patients who withdraw from the study due to adverse events.

    Measured: weeks1, 2, 4, 8, 12, 16, 20, 24, 36 , 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2022
  2. Study startApr 2022 (estimated)
  3. Primary completionAug 2023 (estimated)
  4. Study completionAug 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05284175
Sponsor's protocol ID
ICP-022-006
Status last verified
Mar 2022
First submitted
9 Mar 2022
Last updated
17 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Orelabrutinib in people with Neuromyelitis Optica Spectrum Disorder, run by Peking Union Medical College Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yan Xu, Doctor (18601355218, xuyanpumch@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Annualized relapse rate at week 48 compared with that before baseline. (time frame: week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05284175.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2022.

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