Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)Phase 1/2NCT07696377
An Exploratory Study of Obinutuzumab β in the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy
A Phase 1/2 study testing Obinutuzumab β in people with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) and Obinutuzumab β, run by Zhongming Qiu.
Trial summary
This clinical trial aims to evaluate the safety and efficacy of obinutuzumab β in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). The key research objectives are as follows:1. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), Obinutuzumab β
- What is being tested?
- Obinutuzumab β
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2026to 28 Feb 2031
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 18 and ≤ 75 years at screening.
- Diagnosed with definite chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) according to the 2021 criteria of the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS).
- CIDP Disease Activity Status (CDAS) score ≥ 2 at screening.
- Inflammatory Neuropathy Cause and Treatment (INCAT) disability scale score ≥ 2 at the initial screening.
- Voluntarily sign the informed consent form.
- Female participants of childbearing potential must have a negative pregnancy test (serum β-HCG)at screening .Effective contraception shall be used during the study period and for 12 months after the last dose. Male participants and their partners must also agree to use effective contraception.
Who cannot join
- Pure sensory atypical CIDP (as defined by EFNS/PNS).
- Polyneuropathy due to other causes, including but not limited to: multifocal motor neuropathy, monoclonal gammopathy of undetermined significance with anti-myelin-associated glycoprotein (MAG) IgM antibodies, hereditary demyelinating neuropathy, polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes (POEMS) syndrome, lumbosacral radiculoplexus neuropathy, polyneuropathy most likely caused by diabetes mellitus, polyneuropathy most likely caused by systemic diseases, and drug- or toxin-induced polyneuropathy.
- Any other disease that could better account for the patient's symptoms and signs.
- History of any myelopathy or evidence of central demyelination.
- Current or history of alcohol, drug, or substance abuse within 12 months prior to screening.
- Severe psychiatric disorders (e.g., major depressive disorder, psychosis, bipolar disorder), history of suicide attempt, or current suicidal ideation that, in the opinion of the investigator, may place the patient at undue risk or interfere with the patient's compliance with the study protocol.
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- Any uncontrolled active infection or serious infection within 8 weeks prior to screening; clinically significant active or chronic uncontrolled bacterial, viral, or fungal infections, including patients with active viral infection detected at screening: active hepatitis B virus (as indicated by serological tests showing active [acute or chronic] infection), active hepatitis C virus (positive HCV-Ab serology), or human immunodeficiency virus (HIV)-positive serology associated with acquired immunodeficiency syndrome (AIDS)-defining conditions or with a CD4 count ≤ 200 cells/mm³.
- Total immunoglobulin G (IgG) level < 6 g/L at screening.
- Received the following treatments within 6 months prior to screening: any other investigational drug; any anti-CD20 monoclonal antibody or other biologic agents (e.g., rituximab); alemtuzumab; any other monoclonal antibody; cyclophosphamide; interferon; tumor necrosis factor-α inhibitors; fingolimod; methotrexate; azathioprine; mycophenolate mofetil; any other immunomodulatory or immunosuppressive drugs; and oral corticosteroids > 10 mg/day.
- Presence of any other known autoimmune disease that, in the investigator's opinion, may interfere with the accurate assessment of CIDP clinical symptoms.
- Receipt of live-attenuated vaccine within 1 month prior to screening (patients who have received inactivated, subunit, polysaccharide, or conjugate vaccines at any time prior to screening are not excluded).
- History of malignancy, unless the patient is considered cured by adequate treatment with no evidence of recurrence for ≥ 3 years before the first dose. Patients with the following cancers may be included at any time: adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, carcinoma in situ of the breast, or prostate cancer (TNM stage T1a or T1b).
- Patients who have previously participated in an obinutuzumab beta trial and have received at least one dose of obinutuzumab beta.
- Known history of allergy to any component of obinutuzumab beta.
- Clinical evidence of other significant severe diseases; patients who have recently undergone major surgery or are scheduled for major surgery; or any other condition that, in the investigator's judgment, may confound the trial results or place the patient at undue risk.
About this study
Official title: Safety and Efficacy of Obinutuzumab β in Chronic Inflammatory Demyelinating Polyradiculoneuropathy
This clinical trial aims to evaluate the safety and efficacy of obinutuzumab β in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). The key research objectives are as follows:1. To assess the efficacy of obinutuzumab β for the treatment of chronic inflammatory demyelinating polyradiculoneuropathy.2. To assess the safety of obinutuzumab β for the treatment of chronic inflammatory demyelinating polyradiculoneuropathy.Study participants are required to:Receive two intravenous infusions of obinutuzumab β.Attend follow-up examinations and laboratory tests at the study site at Week 1, Week5, Week9, Week 13, Week 25, Week 37, Week 49, Week 61, Week 73.Maintain a daily symptom diary and record the number of rescue treatments.
- Being tested
- Obinutuzumab β
- Medical subject headings
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obinutuzumab βDrug
Administer Obinutuzumab β Injection 600mg intravenously on W1D1, W25D1 of the treatment period
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Not described Receives: Drug: Obinutuzumab β |
What is being measured
The primary outcome is the main question the study is designed to answer.
Within 49 weeks, relapse risk is defined as a ≥1-point increase from baseline in INCAT score. The primary outcome is the proportion of patients meeting this criterion, with 95% CI.
Measured: Within 49 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start15 Jul 2026 (estimated)
- Primary completion30 Jan 2030 (estimated)
- Study completion28 Feb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongming Qiu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhongming Qiu, Xinqiao Hospital of Chongqing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07696377
- Sponsor's protocol ID
- 2026-205-02
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes