Refractory Chronic Inflammatory Demyelinating PolyneuropathyNCT07597733
Telitacicept for Refractory Chronic Inflammatory Demyelinating Polyneuropathy
A study testing Conventional Therapy and Telitacicept in people with Refractory Chronic Inflammatory Demyelinating Polyneuropathy, run by Sichuan Academy of Medical Sciences at 1 site in China.
Trial summary
This multicenter, randomized, controlled trial aims to evaluate the efficacy and safety of Telitacicept in patients with refractory chronic inflammatory demyelinating polyneuropathy (CIDP). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Refractory Chronic Inflammatory Demyelinating Polyneuropathy
- What is being tested?
- Conventional Therapy and Telitacicept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 26 Sep 2025to 31 Aug 2027
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Progressive neurological disease unrelated to CIDP.
- Limb numbness or weakness caused by other etiologies, including but not limited to hereditary demyelinating neuropathy, neuropathy secondary to infection or systemic disease, diabetic neuropathy, drug- or toxin-induced neuropathy, multifocal motor neuropathy, polyneuropathy associated with IgM monoclonal gammopathy, POEMS syndrome, cerebral infarction, acute myelitis, multiple sclerosis, neuromyelitis optica spectrum disorder, or other conditions that may cause limb numbness or muscle weakness.
- Active hepatitis or severe hepatic dysfunction, defined as liver function test values greater than two times the upper limit of normal. Participants who are positive for hepatitis B surface antigen (HBsAg) will be excluded. Participants who are positive only for hepatitis B core antibody (HBc-Ab) must undergo quantitative HBV-DNA testing and will not be excluded if the result is negative.
- Severe renal impairment, including acute kidney injury or chronic kidney disease, or serum creatinine clearance <60 mL/min calculated using the Cockcroft-Gault equation.
- Current pregnancy, breastfeeding, or planned pregnancy within 48 weeks.
- Participation in another interventional clinical trial within 28 days before enrollment or within five half-lives of the investigational drug, whichever is longer.
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- History of splenectomy.
- History of allergic reactions to contrast agents or intravenously administered human-derived biological products.
- Severe psychiatric symptoms that preclude cooperation with study procedures.
- Treatment with B-cell-depleting agents, such as rituximab, within 6 months before enrollment, or failure of B-cell counts to recover to the normal range, whichever is longer.
- Active tuberculosis.
- Diabetes mellitus.
- Failure to complete serum ganglioside antibody testing to exclude other diseases.
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on the Efficacy and Safety of Telitacicept in Refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
This multicenter, randomized, controlled trial aims to evaluate the efficacy and safety of Telitacicept in patients with refractory chronic inflammatory demyelinating polyneuropathy (CIDP). Eligible patients will be randomly assigned to receive either conventional therapy alone or Telitacicept plus conventional therapy for 24 weeks. Efficacy will be assessed using CIDP-related clinical and functional measures, including the Inflammatory Neuropathy Cause and Treatment (INCAT) disability score, Inflammatory Rasch-built Overall Disability Scale (I-RODS), Medical Research Council (MRC) sum score, grip strength, and the Timed Up and Go (TUG) test. Safety will be evaluated by monitoring adverse events, including their onset, duration, clinical manifestations, and management.
- Being tested
- Conventional Therapy, Telitacicept
- 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.
Conventional TherapyDrug
Also called Intravenous immunoglobulin, Corticosteroids, Immunosuppressive agents
Conventional therapy may include intravenous immunoglobulin or corticosteroids, with immunosuppressive agents permitted when clinically indicated.
TelitaciceptDrug
Telitacicept will be administered by subcutaneous injection in addition to conventional therapy for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Therapy Group | Active comparator | Participants in this group will receive conventional therapy, including intravenous immunoglobulin or corticosteroids, with immunosuppressive agents permitted when clinically indicated. Receives: Drug: Conventional Therapy |
| Telitacicept Plus Conventional Therapy Group | Experimental | Participants in this group will receive Telitacicept in addition to conventional therapy for 24 weeks. Conventional therapy may include intravenous immunoglobulin or corticosteroids, with immunosuppressive agents permitted when clinically indicated. Receives: Drug: Telitacicept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Confirmed Evidence of Clinical Improvement
Percentage of participants with confirmed evidence of clinical improvement, defined according to prespecified improvements in CIDP-related clinical and functional assessments.
Measured: Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24
Change From Baseline in Adjusted INCAT Disability Score
Change from baseline in the adjusted Inflammatory Neuropathy Cause and Treatment disability score.
Measured: Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24
Change From Baseline in MRC Sum Score
Change from baseline in the Medical Research Council sum score.
Measured: Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24
Change From Baseline in I-RODS Score
Change from baseline in the Inflammatory Rasch-built Overall Disability Scale score.
Measured: Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24
Change From Baseline in Timed Up and Go Test
Change from baseline in the Timed Up and Go test.
Measured: Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24
Change From Baseline in Mean Grip Strength
Change from baseline in mean grip strength.
Measured: Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24
Secondary outcomes (2)
Incidence of Adverse Events
Incidence of adverse events during the study period, including the time of onset, duration, clinical manifestations, severity, relationship to study treatment, and actions taken.
Measured: Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24
Change From Baseline in Serum IgG Levels
Change from baseline in serum immunoglobulin G levels during the study period.
Measured: Baseline, Week 2, Week 4, Week 8, Week 16, and 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 May 2026
- Study start26 Sep 2025
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Chronic Inflammatory Demyelinating PolyneuropathyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cunjin Zhang, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07597733
- Sponsor's protocol ID
- 2025679-2
- Status last verified
- May 2026
- First submitted
- 17 Nov 2025
- Last updated
- 19 May 2026
- 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 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Efficacy and Safety of Telitacicept in Refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
- ClinicalTrials.gov ID
- NCT07597733
- Acronym / sponsor ID
- 2025679-2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Sichuan Academy of Medical SciencesUniversity, hospital or other
- Study start
- 26 Sep 2025 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 19 May 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.
This multicenter, randomized, controlled trial aims to evaluate the efficacy and safety of Telitacicept in patients with refractory chronic inflammatory demyelinating polyneuropathy (CIDP). Eligible patients will be randomly assigned to receive either conventional therapy alone or Telitacicept plus conventional therapy for 24 weeks. Efficacy will be assessed using CIDP-related clinical and functional measures, including the Inflammatory Neuropathy Cause and Treatment (INCAT) disability score, Inflammatory Rasch-built Overall Disability Scale (I-RODS), Medical Research Council (MRC) sum score, grip strength, and the Timed Up and Go (TUG) test. Safety will be evaluated by monitoring adverse events, including their onset, duration, clinical manifestations, and management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Therapy Group | Active comparator | Drug: Conventional TherapyParticipants in this group will receive conventional therapy, including intravenous immunoglobulin or corticosteroids, with immunosuppressive agents permitted when clinically indicated. |
| Telitacicept Plus Conventional Therapy Group | Experimental | Drug: TelitaciceptParticipants in this group will receive Telitacicept in addition to conventional therapy for 24 weeks. Conventional therapy may include intravenous immunoglobulin or corticosteroids, with immunosuppressive agents permitted when clinically indicated. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (14 listed)
- Progressive neurological disease unrelated to CIDP.
- Limb numbness or weakness caused by other etiologies, including but not limited to hereditary demyelinating neuropathy, neuropathy secondary to infection or systemic disease, diabetic neuropathy, drug- or toxin-induced neuropathy, multifocal motor neuropathy, polyneuropathy associated with IgM monoclonal gammopathy, POEMS syndrome, cerebral infarction, acute myelitis, multiple sclerosis, neuromyelitis optica spectrum disorder, or other conditions that may cause limb numbness or muscle weakness.
- Active hepatitis or severe hepatic dysfunction, defined as liver function test values greater than two times the upper limit of normal. Participants who are positive for hepatitis B surface antigen (HBsAg) will be excluded. Participants who are positive only for hepatitis B core antibody (HBc-Ab) must undergo quantitative HBV-DNA testing and will not be excluded if the result is negative.
- Severe renal impairment, including acute kidney injury or chronic kidney disease, or serum creatinine clearance <60 mL/min calculated using the Cockcroft-Gault equation.
- Current pregnancy, breastfeeding, or planned pregnancy within 48 weeks.
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 |
|---|---|---|
| Conventional TherapyAlso: Intravenous immunoglobulin, Corticosteroids, Immunosuppressive agentsConventional therapy may include intravenous immunoglobulin or corticosteroids, with immunosuppressive agents permitted when clinically indicated. | Drug | Conventional Therapy Group |
| TelitaciceptTelitacicept will be administered by subcutaneous injection in addition to conventional therapy for 24 weeks. | Drug | Telitacicept Plus Conventional Therapy Group |
Primary outcome
Percentage of Participants With Confirmed Evidence of Clinical Improvement
Time frame: Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24
Percentage of participants with confirmed evidence of clinical improvement, defined according to prespecified improvements in CIDP-related clinical and functional assessments.
Change From Baseline in Adjusted INCAT Disability Score
Time frame: Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24
Change from baseline in the adjusted Inflammatory Neuropathy Cause and Treatment disability score.
Change From Baseline in MRC Sum Score
Time frame: Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24
Change from baseline in the Medical Research Council sum score.
Change From Baseline in I-RODS Score
Time frame: Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24
Change from baseline in the Inflammatory Rasch-built Overall Disability Scale score.
Change From Baseline in Timed Up and Go Test
Time frame: Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24
Change from baseline in the Timed Up and Go test.
Change From Baseline in Mean Grip Strength
Time frame: Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24
Change from baseline in mean grip strength.
2 secondary outcomes
Incidence of Adverse Events
Time frame: Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24
Change From Baseline in Serum IgG Levels
Time frame: Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24
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 19 May 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Therapy and Telitacicept in people with Refractory Chronic Inflammatory Demyelinating Polyneuropathy, run by Sichuan Academy of Medical Sciences 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 0 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 19 May 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Confirmed Evidence of Clinical Improvement (time frame: Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24). The study lists 6 primary outcomes in all. 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 19 May 2026.