An Exploratory Study of Obinutuzumab β in the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP); Obinutuzumab β
• Intervention / Treatment: Drug: Obinutuzumab β

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged ≥ 18 and ≤ 75 years at screening.
2. 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).
3. CIDP Disease Activity Status (CDAS) score ≥ 2 at screening.
4. Inflammatory Neuropathy Cause and Treatment (INCAT) disability scale score ≥ 2 at the initial screening.
5. Voluntarily sign the informed consent form.
6. 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.

Exclusion Criteria:

1. Pure sensory atypical CIDP (as defined by EFNS/PNS).
2. 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.
3. Any other disease that could better account for the patient's symptoms and signs.
4. History of any myelopathy or evidence of central demyelination.
5. Current or history of alcohol, drug, or substance abuse within 12 months prior to screening.
6. 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.
7. 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.
8. Total immunoglobulin G (IgG) level < 6 g/L at screening.
9. 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.
10. Presence of any other known autoimmune disease that, in the investigator's opinion, may interfere with the accurate assessment of CIDP clinical symptoms.
11. 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).
12. 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).
13. Patients who have previously participated in an obinutuzumab beta trial and have received at least one dose of obinutuzumab beta.
14. Known history of allergy to any component of obinutuzumab beta.
15. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group	Drug: Obinutuzumab β; Administer Obinutuzumab β Injection 600mg intravenously on W1D1, W25D1 of the treatment period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	Within 49 weeks

Collaborators and Investigators

• Sponsor: Zhongming Qiu

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): January 30, 2030
• Study Completion (Estimated): February 28, 2031

Study Registration Dates

• First Submitted: July 6, 2026
• First Submitted That Met QC Criteria: July 6, 2026
• First Posted (Actual): July 10, 2026

Study Record Updates

• Last Update Posted (Actual): July 10, 2026
• Last Update Submitted That Met QC Criteria: July 6, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Autoimmune Diseases; Immune System Diseases; Peripheral Nervous System Diseases; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Polyneuropathies; Polyradiculoneuropathy; Pathological Conditions, Signs and Symptoms; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
• Other Study ID Numbers: 2026-205-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No