Narcolepsy Type 1 (NT1)Phase 1/2NCT07871006
Ofatumumab in Treatment-Refractory¬ Narcolepsy Type 1
A Phase 1/2 study testing ofatumumab 20mg in people with Narcolepsy Type 1 (NT1), run by Xijing Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if ofatumumab works to treat drug-Refractory¬ Narcolepsy Type 1. It will also learn about the safety of ofatumumab. The main questions it aims to answer are: Does ofatumumab could improve persistent or chronic NT1 who had insufficient responses to multiple prior treatment… Read more about this study
- Who is it for?
- Ages 10 to 60 years
- Conditions the study is for
- Narcolepsy Type 1 (NT1)
- What is being tested?
- ofatumumab 20mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to 31 Dec 2027
- Phase
- Phase 1/2
- 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 10 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patients who were clinically diagnosed with narcolepsy type 1
- aged10-60 years, male or female.
- A lumbar puncture was performed to evaluate the CSF orexin-A level.
- HLA typing was performed.
- Patients who had previously failed (no response or no maintenance) guideline- specified first-line therapy for narcolepsy and had previously received at least one guideline-specified second-line treatment for narcolepsy type 1and failed (no response or no maintenance). Or patients who refused to drug treatment.
- Subjects with no significant laboratory abnormalities during screening.
- Patients and their legal guardians must comprehensively understand and be able to adhere to the study protocol requirements and willingly sign the informed consent form.
Who cannot join
- Patients allergic to ofatumumab, or had failed to respond to previous treatment with ofatumumab.
- Patients were excluded if they had a previous immune disease, or patients diagnosed with various secondary and hereditary auto-immune disorders, contraindications to lumbar puncture, conditions or medication with known substantial impact on the immune system, with impact on the result of lumbar puncture.
- Patients with uncontrollable primary diseases of important organs, such as liver failure, heart failure, renal failure and other diseases.
- Patients who are positive for HIV antibodies or syphilis antibodies.
- Patients accompanied by uncontrollable active infection, including hepatitis B, hepatitis C, cytomegalovirus, EB virus, etc.
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
Xijing Hospital
Xi'an, Shaanxi, 710032
Xiaoli Wang, MSc, 029-84771058, xjwxl2012@163.com
About this study
The goal of this clinical trial is to learn if ofatumumab works to treat drug-Refractory¬ Narcolepsy Type 1. It will also learn about the safety of ofatumumab. The main questions it aims to answer are:
- Does ofatumumab could improve persistent or chronic NT1 who had insufficient responses to multiple prior treatment regimens or declined conventional medications?
- The safety -What medical problems do participants have when taking ofatumumab? Researchers will compare Epworth Sleepiness Scale and cataplexy frequency before and after ofatumumab treatment to see if ofatumumab works to treat drug-Refractory¬ Narcolepsy Type 1.
Read more
Participants will:
- Take one dose of ofatumumab and monitoring one day for the injection-related reactions
- Visit the clinic at one month after ofatumumab for checkups and tests
- Keep a diary of their symptoms
- Conditions
- Narcolepsy Type 1 (NT1)
- Being tested
- ofatumumab 20mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ofatumumab 20mgBiological
all participants will be treated with one dose of subcutaneous injections of ofatumumab
| Study group | Role | What they receive |
|---|---|---|
| Ofatumumab in Treatment-Refractory¬ Narcolepsy Type 1 | Experimental | Not described Receives: Biological: ofatumumab 20mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Epworth Sleepiness Scale （ESS ：0-24）
The ESS scale contain eight items. Each item is rated from 0 to 3, with 0 meaning you would never doze or fall asleep in a given situation, and 3 meaning there is a very high chance that you would doze or fall asleep in that situation. The ESS score was assessed at baseline and after the first dose, higher scores mean a worse outcome.
Measured: one month
cataplexy rate
cataplexy rate was assessed through completion of an electronic patient-reported outcome diary.
Measured: one month
Secondary outcomes (2)
assessment of adverse events
the incidence and severity of adverse events and serious adverse events were assessed.
Measured: one week
assessment of adverse events
the incidence and severity of adverse events and serious adverse events were assessed.
Measured: within one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start1 Oct 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Narcolepsy Type 1 (NT1)Studies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yonghong Liu, MD;PhD, Principal investigator, The First Affiliated Hospital of Air Force Medicial University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871006
- Sponsor's protocol ID
- XJLL-KY-20252404
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Donjacour CE, Lammers GJ. A remarkable effect of alemtuzumab in a patient suffering from narcolepsy with cataplexy. J Sleep Res. 2012 Aug;21(4):479-80. doi: 10.1111/j.1365-2869.2011.00985.x. Epub 2011 Dec 5. No abstract available.
PubMed 22142323Wasling P, Malmestrom C, Blennow K. CSF orexin-A levels after rituximab treatment in recent onset narcolepsy type 1. Neurol Neuroimmunol Neuroinflamm. 2019 Sep 4;6(6):e613. doi: 10.1212/NXI.0000000000000613. Print 2019 Nov. No abstract available.
PubMed 31484686Cross AH, Stark JL, Lauber J, Ramsbottom MJ, Lyons JA. Rituximab reduces B cells and T cells in cerebrospinal fluid of multiple sclerosis patients. J Neuroimmunol. 2006 Nov;180(1-2):63-70. doi: 10.1016/j.jneuroim.2006.06.029. Epub 2006 Aug 14.
PubMed 16904756Wang X, Zhang X, Yuan N, Liu Y. Ofatumumab treatment in new-onset narcolepsy type 1 following SARS-CoV-2 infection. Ann Clin Transl Neurol. 2025 Mar;12(3):666-669. doi: 10.1002/acn3.52284. Epub 2024 Dec 27.
PubMed 39729629
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ofatumumab in Treatment-Refractory¬ Narcolepsy Type 1
- ClinicalTrials.gov ID
- NCT07871006
- Acronym / sponsor ID
- XJLL-KY-20252404
- Conditions
- Narcolepsy Type 1 (NT1)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Oct 2026 (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 goal of this clinical trial is to learn if ofatumumab works to treat drug-Refractory¬ Narcolepsy Type 1. It will also learn about the safety of ofatumumab. The main questions it aims to answer are:
- Does ofatumumab could improve persistent or chronic NT1 who had insufficient responses to multiple prior treatment regimens or declined conventional medications?
- The safety -What medical problems do participants have when taking ofatumumab? Researchers will compare Epworth Sleepiness Scale and cataplexy frequency before and after ofatumumab treatment to see if ofatumumab works to treat drug-Refractory¬ Narcolepsy Type 1.
Participants will:
- Take one dose of ofatumumab and monitoring one day for the injection-related reactions
- Visit the clinic at one month after ofatumumab for checkups and tests
- Keep a diary of their symptoms
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ofatumumab in Treatment-Refractory¬ Narcolepsy Type 1 | Experimental | Biological: ofatumumab 20mg |
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- patients who were clinically diagnosed with narcolepsy type 1
- aged10-60 years, male or female.
- A lumbar puncture was performed to evaluate the CSF orexin-A level.
- HLA typing was performed.
- Patients who had previously failed (no response or no maintenance) guideline- specified first-line therapy for narcolepsy and had previously received at least one guideline-specified second-line treatment for narcolepsy type 1and failed (no response or no maintenance). Or patients who refused to drug treatment.
Key exclusion criteria (5 listed)
- Patients allergic to ofatumumab, or had failed to respond to previous treatment with ofatumumab.
- Patients were excluded if they had a previous immune disease, or patients diagnosed with various secondary and hereditary auto-immune disorders, contraindications to lumbar puncture, conditions or medication with known substantial impact on the immune system, with impact on the result of lumbar puncture.
- Patients with uncontrollable primary diseases of important organs, such as liver failure, heart failure, renal failure and other diseases.
- Patients who are positive for HIV antibodies or syphilis antibodies.
- Patients accompanied by uncontrollable active infection, including hepatitis B, hepatitis C, cytomegalovirus, EB virus, etc.
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 |
|---|---|---|
| ofatumumab 20mgall participants will be treated with one dose of subcutaneous injections of ofatumumab | Biological | Ofatumumab in Treatment-Refractory¬ Narcolepsy Type 1 |
Primary outcome
the Epworth Sleepiness Scale （ESS ：0-24）
Time frame: one month
The ESS scale contain eight items. Each item is rated from 0 to 3, with 0 meaning you would never doze or fall asleep in a given situation, and 3 meaning there is a very high chance that you would doze or fall asleep in that situation. The ESS score was assessed at baseline and after the first dose, higher scores mean a worse outcome.
cataplexy rate
Time frame: one month
cataplexy rate was assessed through completion of an electronic patient-reported outcome diary.
2 secondary outcomes
assessment of adverse events
Time frame: one week
assessment of adverse events
Time frame: within one week
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 13 Oct 2026.
- Background: PubMed 22142323Donjacour CE, Lammers GJ. A remarkable effect of alemtuzumab in a patient suffering from narcolepsy with cataplexy. J Sleep Res. 2012 Aug;21(4):479-80. doi: 10.1111/j.1365-2869.2011.00985.x. Epub 2011 Dec 5. No abstract available.
- Background: PubMed 31484686Wasling P, Malmestrom C, Blennow K. CSF orexin-A levels after rituximab treatment in recent onset narcolepsy type 1. Neurol Neuroimmunol Neuroinflamm. 2019 Sep 4;6(6):e613. doi: 10.1212/NXI.0000000000000613. Print 2019 Nov. No abstract available.
- Background: PubMed 16904756Cross AH, Stark JL, Lauber J, Ramsbottom MJ, Lyons JA. Rituximab reduces B cells and T cells in cerebrospinal fluid of multiple sclerosis patients. J Neuroimmunol. 2006 Nov;180(1-2):63-70. doi: 10.1016/j.jneuroim.2006.06.029. Epub 2006 Aug 14.
- Background: PubMed 39729629Wang X, Zhang X, Yuan N, Liu Y. Ofatumumab treatment in new-onset narcolepsy type 1 following SARS-CoV-2 infection. Ann Clin Transl Neurol. 2025 Mar;12(3):666-669. doi: 10.1002/acn3.52284. Epub 2024 Dec 27.
- Individual participant dataSharing planned: Yes
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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.
Yonghong Liu, MD;PhD principal investigator
The First Affiliated Hospital of Air Force Medicial University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ofatumumab 20mg in people with Narcolepsy Type 1 (NT1), run by Xijing 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 5 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 13 Oct 2026. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Yonghong Liu, MD;PhD (029-84771058, xjwxl2012@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Epworth Sleepiness Scale （ESS ：0-24） (time frame: one month). The study lists 2 primary outcomes in all. 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 NCT07871006, which also lists 4 linked publications.
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 13 Oct 2026.