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Neuromyelitis Optica Spectrum DisordersPhase 2NCT04670770

An Open Label Study of the Effects of SHR1459 in NMOSDs Patients

A Phase 2 study testing Drug - SHR1459 in people with Neuromyelitis Optica Spectrum Disorders, run by Reistone Biopharma Company Limited at 8 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an open-label study, to evaluate the efficacy and safety of SHR1459 in participants with NMOSDs. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Neuromyelitis Optica Spectrum Disorders
What is being tested?
Drug - SHR1459
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
8 sitesChina
Study dates
20 Jan 2021to 15 Aug 2022
Phase
Phase 2
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

  • 18-75 years of age.
  • Diagnosis of AQP4-IgG positive NMOSD according to IPND diagnostic criteria 2015 at screening.
  • Having a documented history of 2 or more NMOSD relapse required rescue therapy(ies) within the last 12 months.
  • Subjects must be stable treatment (if any) for more than 1 month before starting the IP treatment, which is defined as follows:- Expanded disability status scale (EDSS) score≦7.5
  • Written informed consent obtained before any study procedure.
  • Subjects are willing and able to comply with the visit schedule and treatment plan, laboratory tests and other study procedures.

Who cannot join

  • Allergic to the investigative product or any ingredient in the investigative product.
  • Past or current malignancy, except for cutaneous non-metastatic basal cell carcinoma or squamous cell carcinoma that has been adequately treated or removed
  • The subject currently has a central nervous system (CNS) disease that may affect the assessment of NMOSD;
  • Severe and uncontrolled conditions that the investigator determines may affect subjects' safety, trial compliance, evaluation of the end point, or the need to use medications not permitted in the protocol;
  • The investigator judges that the subject has a disease that affects the absorption, distribution, metabolism and excretion of the drug;
  • The subjects had any major clinical infection and was hospitalized or treated with parenteral antibiotics within 1 month before screening; Or other infections that investigator thought might aggravate as a result of participating in the study;
Show all 30Show fewer
  • The subject may have an active, latent or undertreated Mycobacterium tuberculosis (ie, tuberculosis [TB]) infection, defined as follows:
  • The result of QuantiFERON-TB Gold (QFT Gold test) was positive or the result of T-SPOT.TB was positive within 3 months before screening/screening period.
  • Or chest imaging examinations suggest the presence of active tuberculosis infection within 3 months before screening / during the screening period;
  • The result of QuantiFERON-TB Gold (QFT Gold test) was positive or the result of T-SPOT.TB was positive within 3 months before screening/screening period.
  • Or chest imaging examinations suggest the presence of active tuberculosis infection within 3 months before screening / during the screening period;
  • Positive laboratory tests related to human immunodeficiency virus (HIV) or hepatitis B virus or hepatitis C virus;
  • Have received BTK inhibitors (e.g. ibrutinib) at any time in the past.
  • Received B-cell targeted therapy (such as rituximab) within 12 weeks before the first administration.
  • Received biological agents such as eculizumab, tocilizumab, Satralizumab, Alemtuzumab, Natalizumab within 12 weeks before the first administration;
  • Subjects who may receive any live attenuated vaccine during the screening period or have received any live virus vaccine within 8 weeks prior to initial administration;
  • Any concomitant disease other than NMOSD that requires glucocorticoid therapy (oral or IV) within the 6 months prior to screening.
  • Abnormal and clinically significant ECG examination during screening.
  • Alanine glutamate aminotransferase (ALT)>2 times the upper limit of normal (ULN) and/or glutamate aspartate aminotransferase (AST)>2 times ULN and/or bilirubin>2 times ULN during the screening period ULN;
  • Abnormal white blood cell count, neutrophil count, lymphocyte count, or platelet count during the screening period are considered unsuitable for participating in the study after the investigator's assessment (refer to the following criteria):
  • Hemoglobin <100 g/L or hematocrit <30%;
  • White blood cell (WBC) count<3.0×109/L (<3000/mm3) or ANC<1.2×109/L (<1200/mm3);
  • Lymphocytes <0.8×109/L (<800/mm3);
  • Platelet count<100×109/L (<100,000/mm3)
  • eGFR≤60 ml/min (calculated according to Cockcroft-Gault) or receiving dialysis during the screening period.
  • Unable to undergo MRI scans. History of clinically significant CNS trauma (e.g. traumatic brain injury, cerebral contusion, spinal cord compression)
  • Pregnant or breastfeeding women;
  • Use of an investigational drug or other experimental therapy within 4 weeks, 5 pharmacokinetic half-lives, or the duration of biological effect (whichever is longer) prior to screening.
  • Any other conditions in which the investigator or sponsor believes that the subject is not suitable for inclusion in the study.
  • -

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

China8 sites

  • Xiangya Hospital Of Central South University

    Changsha

  • West China Hospital Sichuan University

    Chengdu

  • Lanzhou University Second Hospital

    Lanzhou

  • People's Hospital of Rizhao

    Rizhao

  • Huashan Hospital Affiliated To Fudan University

    Shanghai

  • First Hospital Of Shanxi Medical University

    Taiyuan

  • Tangdu Hosiptal

    Xi'an

  • The First Affiliated Hospital Of Zhengzhou University

    Zhengzhou

Other trials in China

About this study

Official title: An Open Label Phase II Clinical Trial Evaluating the Efficacy and Safety of SHR1459 in Adult Patients With Neuromyelitis Optical Spectrum Disorders (NMOSDs)

This is an open-label study, to evaluate the efficacy and safety of SHR1459 in participants with NMOSDs.

Read the detailed description

Therefore, the investigators of this study are investigating whether SHR1459 could prevent relapse of NMOSDs.

The primary objective of this study is to evaluate the effectiveness of SHR1459 in NMOSDs patients.

The secondary objectives are to determine:

The safety profile of SHR 1459 in patients with NMOSDs. Whether SHR1459 reduce MRI lesions and APQ4-Abs level.

Being tested
Drug - SHR1459
Medical subject headings
Neuromyelitis Optica

What participants receive

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

  • Drug - SHR1459Drug

    Oral Tablets taken once daily for 52 weeks

Study groups in NCT04670770
Study groupRoleWhat they receive
SHR1459ExperimentalSHR1459
Receives: Drug: Drug - SHR1459

What is being measured

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

  1. Evaluate the efficacy of SHR1459 in patients with relapsing NMOSDs

    Comparison of the annualized relapse rate at 52 weeks of treatment with the annualized recurrence rate before screening.

    Measured: 52 weeks

Secondary outcomes (10)

  1. Comparison of the annualized relapse rate at 52 weeks of treatment with the year before screening.

    Comparison of the annualized relapse rate at 52 weeks of treatment with the year before screening.

    Measured: 52 weeks

  2. Proportion of subjects who are relapse-free at week 24 and 52.

    Proportion of subjects who are relapse-free at week 24 and 52.

    Measured: 52 weeks

  3. Changes in the expanded disability status scale (EDSS) at week 4, 12, 24, 36, and 52 compared to baseline.

    Changes in the expanded disability status scale (EDSS) at week 4, 12, 24, 36, and 52 compared to baseline.

    Measured: 52 weeks

  4. Changes in low-contrast visual acuity (LCVA) score at week 4, 12, 24, 36 and 52 compared to baseline

    Changes in low-contrast visual acuity (LCVA) score at week 4, 12, 24, 36 and 52 compared to baseline.

    Measured: 52 weeks

  5. Changes in cumulative active MRI lesion count at week 24 and 52 compared to baseline.

    Changes in cumulative active MRI lesion count at week 24 and 52 compared to baseline.

    Measured: 52 weeks

  6. Changes in health related quality of life (HRQoL) at week 12, 24, 36 and 52 compared to baseline.

    Changes in health related quality of life (HRQoL) at week 12, 24, 36 and 52 compared to baseline.

    Measured: 52 weeks

  7. Changes in pain severity score (NRS) at week 4, 12, 24, 36 and 52 compared to baseline.

    Changes in pain severity score (NRS) at week 4, 12, 24, 36 and 52 compared to baseline.

    Measured: 52 weeks

  8. Changes in serum AQP4-IgG titer from baseline at 4, 12, 24, 36, 52 weeks.

    Changes in serum AQP4-IgG titer from baseline at 4, 12, 24, 36, 52 weeks.

    Measured: 52 weeks

  9. Changes in the absolute value of B lymphocytes and total immunoglobulins (IgA, IgG and IgM) from baseline after 12, 24, and 52 weeks of treatment.

    Changes in the absolute value of B lymphocytes and total immunoglobulins (IgA, IgG and IgM) from baseline after 12, 24, and 52 weeks of treatment

    Measured: 52 weeks

  10. The plasma concentration of SHR1459 and its metabolite SHR1459-02 in NMOSD patients.

    The plasma concentration of SHR1459 and its metabolite SHR1459-02 in NMOSD patients

    Measured: 52 weeks

Timeline

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

  1. First posted17 Dec 2020
  2. Study start20 Jan 2021
  3. Primary completion15 Aug 2022
  4. Study completion15 Aug 2022

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04670770
Sponsor's protocol ID
RSB20621
Status last verified
Mar 2023
First submitted
10 Dec 2020
Last updated
23 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Drug - SHR1459 in people with Neuromyelitis Optica Spectrum Disorders, run by Reistone Biopharma Company Limited at 8 sites 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 6 inclusion and 30 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: finished, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the efficacy of SHR1459 in patients with relapsing NMOSDs (time frame: 52 weeks). 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 NCT04670770.

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 23 Mar 2023.

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