Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)Phase 3RIPERT-CIDPNCT06858722
Ripertamab for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy
A Phase 3 study testing ripertamab in people with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), run by Zhongming Qiu.
Trial summary
The goal of this clinical trial is to learn if ripertamab works to treat chronic inflammatory demyelinating polyneuropathy. It will also learn about the safety of ripertamab. The main questions it aims to answer are: Does ripertamab reduce the risk of recurrence in patients? What medical problems do participants have… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
- What is being tested?
- ripertamab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 175 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2025to 31 Dec 2027
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand the requirements of the trial, provide written informed consent (including consent to use and disclose health information related to the study), and willing and able to comply with the trial protocol procedures (including required trial visits);
- Aged 18 years or older at the time of signing the informed consent form;
- Diagnosed with definite CIDP according to the 2021 EFNS/PNS criteria;
- CIDP Disease Activity Status (CDAS) score of ≥2 at screening;
- INCAT score of at least 2 at initial screening;
- Meet one of the following conditions: currently receiving oral corticosteroid therapy (equivalent to prednisone/ prednisolone ≤10 mg/day), and/or intravenous immunoglobulin (IVIg) or subcutaneous immunoglobulin (SCIg), but willing to discontinue this treatment before screening; or untreated: no prior treatment; or discontinued corticosteroids and/or IVIg or SCIg at least 6 months before screening;
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- Women of childbearing potential with a negative pregnancy test at screening and a negative urine pregnancy test at baseline;
- Women of childbearing potential must use a highly effective contraceptive method (failure rate less than 1% per year) from screening until 90 days after the last administration of the investigational medicinal product (IMP);
- Men who are not surgically sterile and have partners of childbearing potential must use condoms, and their partners must use a highly effective contraceptive method from screening until 90 days after the last administration of the IMP (failure rate less than 1% per year). Men who are surgically sterile (documented azoospermia following vasectomy) may be included. In addition, men must not donate sperm from screening until 90 days after the last administration of the IMP.
Who cannot join
- Pure sensory atypical CIDP (defined by EFNS/PNS criteria);
- Polyneuropathy due to other causes, including but not limited to: multifocal motor neuropathy, monoclonal gammopathy of undetermined significance caused by anti-myelin-associated glycoprotein immunoglobulin M antibodies, hereditary demyelinating neuropathy, polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes syndrome, lumbosacral radiculoplexus neuropathy, polyneuropathy most likely caused by diabetes, polyneuropathy most likely caused by systemic disease, polyneuropathy caused by drugs or toxins;
- Any disease that can better explain the patient's symptoms and signs;
- History of any myelopathy or evidence of central demyelination;
- Current or past (within 12 months before screening) history of alcohol, drug, or substance abuse;
- Severe psychiatric disorder (e.g., major depression, psychosis, bipolar disorder), history of suicide attempt, or current suicidal ideation that the investigator believes may pose undue risk to the patient or affect the patient's ability to comply with the trial protocol;
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- Clinically significant active or chronic uncontrolled bacterial, viral, or fungal infections at screening, including patients with active viral infections detected at screening: active hepatitis B virus (serological tests indicate active [acute or chronic] infection), active hepatitis C virus (HCV) (HCV-Ab seropositive), human immunodeficiency virus seropositive with acquired immunodeficiency syndrome-defining conditions or CD4 count ≤200 cells/mm³;
- Total immunoglobulin G level <6 g/L at screening;
- Received the following treatments: within 1 month before screening (or five half-lives of the drug, whichever is longer): plasmapheresis or immunoadsorption, or any other investigational product; within 6 months before screening: any anti-CD20 monoclonal antibody or other biologic (e.g., rituximab), alemtuzumab, any other monoclonal antibody, cyclophosphamide, interferon, tumor necrosis factor-α inhibitor, fingolimod, methotrexate, azathioprine, mycophenolate mofetil, any other immunomodulatory or immunosuppressive drug, and oral daily corticosteroids >10 mg/day (patients using IVIg, SCIg, corticosteroid pulse therapy, and oral daily corticosteroids ≤10 mg/day may be included);
- Pregnant and breastfeeding women, and those who plan to become pregnant during the trial or within 90 days after the last dose;
- Any other known autoimmune disease that the investigator believes may interfere with the accurate assessment of CIDP clinical symptoms;
- Received live attenuated vaccines within 28 days before screening (patients who received inactivated, subunit, polysaccharide, or conjugate vaccines at any time before screening are not considered exclusion criteria);
- History of malignancy, unless the patient has been free of recurrence for ≥3 years after adequate treatment before the first dose. Patients with the following cancers may be included at any time: adequately treated basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of the breast, or prostate cancer (tumor, node, and metastasis stage T1a or T1b);
- Patients who have previously participated in a Ripertamab trial and received ≥1 dose of Ripertamab;
- Patients with a history of known hypersensitivity to any component of Ripertamab;
- Any other significant severe disease, or recent major surgery or planned major surgery, or any other reason that may confound trial results or pose undue risk to the patient.
About this study
Official title: Safety and Efficacy of Ripertamab in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (RIPERT-CIDP): a Randomised, Double-blind, Multicentre, Placebo-controlled Phase 3 Trial
The goal of this clinical trial is to learn if ripertamab works to treat chronic inflammatory demyelinating polyneuropathy. It will also learn about the safety of ripertamab. The main questions it aims to answer are:
Does ripertamab reduce the risk of recurrence in patients? What medical problems do participants have when taking ripertamab? Researchers will compare ripertamab to a placebo (a look-alike substance that contains no drug) to see if ripertamab works to treat chronic inflammatory demyelinating polyneuropathy.
Read more
Participants will:
A single intravenous infusion of drug ABC or placebo. Visit the clinic for checkups and tests during W1, W2, W4, W8, W12 Keep a diary of their symptoms and the number of times they undergo rescue therapy
- Being tested
- ripertamab, Placebo
- 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.
ripertamabDrug
On Day 1 of the treatment period, an intravenous infusion of Ripertamab at a dose of 375 mg/m² body surface area will be administered.
PlaceboDrug
On Day 1 of the treatment period, an intravenous infusion of Placebo at a dose of 375 mg/m² body surface area will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Not described Receives: Drug: ripertamab |
| Control group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time to first increase of ≥1 point in the aINCAT score compared to baseline.
Measured: Within 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start15 Mar 2025 (estimated)
- 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.
- Other trials for Chronic Inflammatory Demyelinating Polyneuropathy (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 175 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
- NCT06858722
- Sponsor's protocol ID
- 2024-347-02
- Acronym
- RIPERT-CIDP
- Status last verified
- Jan 2025
- First submitted
- 27 Feb 2025
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Ripertamab in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (RIPERT-CIDP): a Randomised, Double-blind, Multicentre, Placebo-controlled Phase 3 Trial
- ClinicalTrials.gov ID
- NCT06858722
- Acronym / sponsor ID
- RIPERT-CIDP / 2024-347-02
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- Zhongming QiuUniversity, hospital or other
- Study start
- 15 Mar 2025 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Mar 2025 (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 ripertamab works to treat chronic inflammatory demyelinating polyneuropathy. It will also learn about the safety of ripertamab. The main questions it aims to answer are:
Does ripertamab reduce the risk of recurrence in patients? What medical problems do participants have when taking ripertamab? Researchers will compare ripertamab to a placebo (a look-alike substance that contains no drug) to see if ripertamab works to treat chronic inflammatory demyelinating polyneuropathy.
Participants will:
A single intravenous infusion of drug ABC or placebo. Visit the clinic for checkups and tests during W1, W2, W4, W8, W12 Keep a diary of their symptoms and the number of times they undergo rescue therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: ripertamab |
| Control group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Able to understand the requirements of the trial, provide written informed consent (including consent to use and disclose health information related to the study), and willing and able to comply with the trial protocol procedures (including required trial visits);
- Aged 18 years or older at the time of signing the informed consent form;
- Diagnosed with definite CIDP according to the 2021 EFNS/PNS criteria;
- CIDP Disease Activity Status (CDAS) score of ≥2 at screening;
- INCAT score of at least 2 at initial screening;
Key exclusion criteria (16 listed)
- Pure sensory atypical CIDP (defined by EFNS/PNS criteria);
- Polyneuropathy due to other causes, including but not limited to: multifocal motor neuropathy, monoclonal gammopathy of undetermined significance caused by anti-myelin-associated glycoprotein immunoglobulin M antibodies, hereditary demyelinating neuropathy, polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes syndrome, lumbosacral radiculoplexus neuropathy, polyneuropathy most likely caused by diabetes, polyneuropathy most likely caused by systemic disease, polyneuropathy caused by drugs or toxins;
- Any disease that can better explain the patient's symptoms and signs;
- History of any myelopathy or evidence of central demyelination;
- Current or past (within 12 months before screening) history of alcohol, drug, or substance abuse;
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 |
|---|---|---|
| ripertamabOn Day 1 of the treatment period, an intravenous infusion of Ripertamab at a dose of 375 mg/m² body surface area will be administered. | Drug | Treatment group |
| PlaceboOn Day 1 of the treatment period, an intravenous infusion of Placebo at a dose of 375 mg/m² body surface area will be administered. | Drug | Control group |
Primary outcome
The time to first increase of ≥1 point in the aINCAT score compared to baseline.
Time frame: Within 24 weeks
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 5 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ripertamab in people with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), run by Zhongming Qiu.
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 9 inclusion and 16 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: opening soon, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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?
The time to first increase of ≥1 point in the aINCAT score compared to baseline. (time frame: Within 24 weeks). 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 5 Mar 2025.