Anti-N-Methyl-D-Aspartate Receptor EncephalitisPhase 2NCT06510283
Efficacy and Safety of Taitacept in Treatment of Refractory or Recurrent Anti-NMDAR/anti-LGI1 Encephalitis
A Phase 2 study testing Taitacept in people with Anti-N-Methyl-D-Aspartate Receptor Encephalitis, run by Beijing Tongren Hospital at 1 site in China.
Trial summary
The main objective is to explore the efficacy and safety of Telitacicept in the treatment of refractory/recurrent anti-NMDAR and anti-LGI1 encephalitis. Through this prospective, single-center, open-label clinical trial, we aim to investigate the effectiveness and safety of Telitacicept in refractory/recurrent… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Anti-N-Methyl-D-Aspartate Receptor Encephalitis
- What is being tested?
- Taitacept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 1 Jul 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥14 years old, male or female;
- Symptoms of autoimmune encephalitis (AE) ≤ 9 months prior to enrollment;
- Diagnosed as autoimmune encephalitis, diagnostic criteria as follows:
- Rapid onset (<3 months) of at least four of the following six major symptoms:
- Abnormal (mental) behavior or cognitive dysfunction
- Speech dysfunction (verbal urgency, hypospeech, mutism)
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- Seizures
- Movement disorders, dyskinesias, or postural rigidity/abnormalities
- Decreased level of consciousness
- Autonomic dysfunction or central hypoventilation in the presence of one or more of the six major symptoms;
- Positive anti-NMDAR (GluN1) IgG antibody detected in CSF or positive serum and/or cerebrospinal fluid LGI1 antibody; c．Reasonable exclusion of other etiologies and other well-defined encephalitis syndromes (e.g., Bickerstaff brainstem encephalitis, acute disseminated encephalomyelitis, Hashimoto encephalopathy, primary CNS vasculitis, Rasmussen encephalitis);
- Refractory AE: ineffective treatment with steroids and rituximab or other immunosuppressants, post-treatment mRS score≥2 (stable for at least 24 hours）;Recurrent AE: at least 2 months after 1st or 2nd line treatment, new symptoms or worsening of existing symptoms (mRS increase>1); 5）Doses of steroids and other immunosuppressants (e.g. azathioprine, mycophenolate mofetil, cyclophosphamide) should be stabilised for 4 weeks prior to enrolment; 6）Ability to obtain patient or proxy consent; 7）Women of childbearing potential should use effective contraception during treatment or avoid heterosexual intercourse for at least 3 months after the last dose of talitacicept;
Who cannot join
- History of other autoimmunity such as SLE, RA, SS. Patients with hyperthyroidism and hypothyroidism cannot be excluded;
- Abnormal laboratory indicators, including but not limited to the following indicators:
- White blood cell count<3×10^9 /L Neutrophil count<1.5×10^9 /L Hemoglobin<85g/L Blood platelet count<80×10^9 /L Serum creatinine>1.5×ULN TBil(total bilirubin) >1.5×ULN ALT>3× ULN AST>3× ULN Alkaline phosphatase>2× ULN Creatine kinase>5× ULN
- Evidence of active infection such as shingles, HIV or active tuberculosis, etc.
- Currently have active hepatitis or have severe liver disease and a history of it.
- Patiens with abnormal Hepatitis B test as follows should be excluded: HbsAg positive; HbsAg negative but HbcAb positive, and HBV-DNA positive. Whereas patients with HbsAg negative but HbcAb positive, and HBV-DNA negative can be included.
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- Exclude patients who are positive for hepatitis C antibodies ;
- Uncontrolled diabetes mellitus: Glycosylated hemoglobin>9.0% or fasting blood glucose≥11.1mmol/L;
- Received any live vaccine within 3 months prior to enrollment or planned to receive any vaccine during the study;
- Received rituximab or other biological therapies within 1 month prior to enrollment;
- Malignancy;
- Allergic to human biological products;
- Participated in any clinical trial within 28 days prior to enrollment or within 5 times the half-life of the investigational drug participating in the clinical trial
- Patients who plan to have children during the trial, or who are pregnant or breastfeeding;
- Alcohol or drug abuse/addiction is known to have an impact on compliance with trial requirements;
- Patients who are deemed unsuitable for the trial by the investigator (e.g., those with severe mental disorders).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tongren Hospital,Capital Medical University
Beijing, Beijing Municipality, 100730
Jiawei Wang, doctor, 18811612263, pengyujing1206@163.com
About this study
The main objective is to explore the efficacy and safety of Telitacicept in the treatment of refractory/recurrent anti-NMDAR and anti-LGI1 encephalitis.
Through this prospective, single-center, open-label clinical trial, we aim to investigate the effectiveness and safety of Telitacicept in refractory/recurrent anti-NMDAR and anti-LGI1 encephalitis by add-on therapy of Telitacicept combined with traditional treatment.
- Being tested
- Taitacept
- Medical subject headings
- Anti-N-Methyl-D-Aspartate Receptor Encephalitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TaitaceptDrug
Also called No other Intervention Names
Telitacicept will be subcutaneously injected at a dose of 240mg per week, lasting for at least 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Taitacept treatment group | Experimental | Telitacicept will be subcutaneously injected at a dose of 240mg per week, lasting for at least 24 weeks. Receives: Drug: Taitacept |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change of mRS score
Refractory encephalitis: rate of patients with mRS score <2 or mRS score improvement of ≥2 points from baseline at week 24; Recurrent encephalitis: proportion of patients with no recurrence and [mRS score <2 or mRS score improvement of ≥2 points from baseline at week 24.
mRS score vary from 0-6 score and higher scores mean a worse outcome.
Measured: from baseline at week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anti-N-Methyl-D-Aspartate Receptor EncephalitisStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiawei Wang, Study director, Beijing Tong Ren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510283
- Sponsor's protocol ID
- TREC2024-KY061
- Status last verified
- Jun 2024
- First submitted
- 15 Jul 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Taitacept in Treatment of Refractory or Recurrent Anti-NMDAR/anti-LGI1 Encephalitis
- ClinicalTrials.gov ID
- NCT06510283
- Acronym / sponsor ID
- TREC2024-KY061
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 19 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective is to explore the efficacy and safety of Telitacicept in the treatment of refractory/recurrent anti-NMDAR and anti-LGI1 encephalitis.
Through this prospective, single-center, open-label clinical trial, we aim to investigate the effectiveness and safety of Telitacicept in refractory/recurrent anti-NMDAR and anti-LGI1 encephalitis by add-on therapy of Telitacicept combined with traditional treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Taitacept treatment group | Experimental | Drug: TaitaceptTelitacicept will be subcutaneously injected at a dose of 240mg per week, lasting for at least 24 weeks. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥14 years old, male or female;
- Symptoms of autoimmune encephalitis (AE) ≤ 9 months prior to enrollment;
- Diagnosed as autoimmune encephalitis, diagnostic criteria as follows:
- Refractory AE: ineffective treatment with steroids and rituximab or other immunosuppressants, post-treatment mRS score≥2 (stable for at least 24 hours）;Recurrent AE: at least 2 months after 1st or 2nd line treatment, new symptoms or worsening of existing symptoms (mRS increase>1); 5）Doses of steroids and other immunosuppressants (e.g. azathioprine, mycophenolate mofetil, cyclophosphamide) should be stabilised for 4 weeks prior to enrolment; 6）Ability to obtain patient or proxy consent; 7）Women of childbearing potential should use effective contraception during treatment or avoid heterosexual intercourse for at least 3 months after the last dose of talitacicept;
Key exclusion criteria (16 listed)
- History of other autoimmunity such as SLE, RA, SS. Patients with hyperthyroidism and hypothyroidism cannot be excluded;
- Abnormal laboratory indicators, including but not limited to the following indicators:
- White blood cell count<3×10^9 /L Neutrophil count<1.5×10^9 /L Hemoglobin<85g/L Blood platelet count<80×10^9 /L Serum creatinine>1.5×ULN TBil(total bilirubin) >1.5×ULN ALT>3× ULN AST>3× ULN Alkaline phosphatase>2× ULN Creatine kinase>5× ULN
- Evidence of active infection such as shingles, HIV or active tuberculosis, etc.
- Currently have active hepatitis or have severe liver disease and a history of it.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TaitaceptAlso: No other Intervention NamesTelitacicept will be subcutaneously injected at a dose of 240mg per week, lasting for at least 24 weeks. | Drug | Taitacept treatment group |
Primary outcome
the change of mRS score
Time frame: from baseline at week 24
Refractory encephalitis: rate of patients with mRS score <2 or mRS score improvement of ≥2 points from baseline at week 24; Recurrent encephalitis: proportion of patients with no recurrence and [mRS score <2 or mRS score improvement of ≥2 points from baseline at week 24. mRS score vary from 0-6 score and higher scores mean a worse outcome.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jiawei Wang study director
Beijing Tong Ren Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Taitacept in people with Anti-N-Methyl-D-Aspartate Receptor Encephalitis, run by Beijing Tongren 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 12 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 20 Nov 2024. 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.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiawei Wang, PHD (010-58266091, pengyujing1206@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change of mRS score (time frame: from baseline at week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2024.