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
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