Study on Batoclimab for Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

2 1

What is this study about?

This clinical trial is focused on studying a condition called Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). CIDP is a neurological disorder that causes progressive weakness and impaired sensory function in the legs and arms. The study is testing a treatment called Batoclimab, which is a solution for injection. Batoclimab is also known by its code name IMVT-1401. The trial will compare the effects of Batoclimab to a placebo in adult participants who have active CIDP.

The purpose of the study is to evaluate how effective Batoclimab is in maintaining a clinical response in people with CIDP who are already receiving treatments like immune globulin or plasma exchange. Participants will be randomly assigned to receive either Batoclimab or a placebo. The study will be conducted over a period of time, and participants will receive regular injections. The trial aims to see if Batoclimab can help prevent relapses, which are periods when symptoms worsen.

Throughout the study, participants will be monitored to assess their response to the treatment. This will include checking for any changes in their condition and measuring their strength and ability to perform daily activities. The study will help determine if Batoclimab is a safe and effective treatment option for people with CIDP.

1 joining the study

Upon joining the study, participation is confirmed for individuals aged 18 or older who have been diagnosed with chronic inflammatory demyelinating polyneuropathy (CIDP) or its variants.

Eligibility is based on specific clinical criteria and diagnostic tests that support the diagnosis of CIDP.

2 treatment administration

Participants receive either the medication batoclimab or a placebo. The placebo is identical in appearance but contains no active substance.

The medication is administered as a subcutaneous injection, which means it is injected under the skin.

3 monitoring and assessment

Throughout the study, participants are monitored to evaluate the effectiveness of the treatment in maintaining clinical response.

Assessments include measuring changes in the adjusted inflammatory neuropathy cause and treatment (Adj INCAT) score, grip strength, and other disability scales.

4 evaluation of outcomes

The primary goal is to determine the proportion of participants who remain free from relapse at Week 36.

Secondary outcomes include the time to first relapse and changes in various clinical scores from the baseline to Week 36.

5 completion of the study

The study is expected to conclude by January 31, 2027.

Participants’ health and response to the treatment are evaluated at the end of the study period.

Who Can Join the Study?

  • You must be 18 years or older at the time of the Screening Visit.
  • You should have been diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), which is a condition affecting the nerves, or one of its variants like multifocal, focal, or motor CIDP.
  • For typical CIDP, you should have:
    • Muscle weakness that is getting worse or comes and goes, affecting both sides of the body, and involves both the upper and lower limbs.
    • Symptoms that have developed over at least 8 weeks.
    • Reduced or absent reflexes in all limbs.
  • For CIDP variants, you should have:
    • Multifocal CIDP: Sensory loss and muscle weakness in different areas, usually more in the upper limbs.
    • Focal CIDP: Sensory loss and muscle weakness in only one limb.
    • Motor CIDP: Only motor symptoms without sensory issues.
  • You need to have test results that support the diagnosis of CIDP, which may include:
    • Tests showing nerve issues that suggest demyelination, which means damage to the protective covering of nerves.
    • Improvement after treatment with immunoglobulin, plasma exchange, or corticosteroids.
    • Imaging tests like ultrasound or MRI showing nerve enlargement.
    • Spinal fluid tests showing high protein levels but normal white blood cell levels.
    • Nerve biopsy showing signs of CIDP like swelling or damage to the nerve covering.
  • For Cohort C, you must have a diagnosis of CIDP with strong evidence from nerve tests.
  • For Cohort D, you must meet the clinical criteria for typical CIDP or one of its variants.
  • There are additional criteria that are detailed in the study protocol.

Who Cannot Join the Study?

  • Patients who are not currently receiving treatments like immune globulin (IVIg or SCIg) or plasma exchange (PLEX) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) cannot participate. Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) is a condition that affects the nerves, causing weakness and numbness.
  • Patients who are not able to maintain a clinical response, which means their condition is not stable or improving with current treatments, are excluded.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population, meaning they might have additional health or social challenges, are excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Turku University Hospital Turku Finland
Azienda Unita Sanitaria Locale Di Bologna Bologna Italy
Katholisches Klinikum Bochum gGmbH Bochum Germany
Copernicus Podmiot Leczniczy Sp. z o.o. Gdansk Poland
Mydvavpxm Ijgosjzscb Cirubcbb Seqqiinj Snf z oinn Warsaw Poland
Uzvazxlzxg Madfqhlynlug Hbmelved Fke Amhyxs Tdfgosnlo Afq Esjxuhtpt Mplzfllt N I Pvzzwow Sofia Bulgaria
Gezwjuy Uvvtcsvvfx Hvyjkime Ov Lbwoipj Larissa Greece
Uobrgfpzsf Gfmbgis Hzsfcfkw Ow Iooxatif Ioannina Greece
Sezlgijdnii Pawhgpobt Zpauoh Ojqbyo Zlurfmlwqz Sncxrah Uuwugniiklitz W Kxjhpgir Cracow Poland
Gnsxovb Uueboipnht Hfceaswu Ol Pnktks Patras Greece
Ukmctaiogd Gznyert Hcpwnmfe Od Auawlvnbwwmdgi Alexandroupoli Greece
Uqhubdcuybtd Lylkqux Leipzig Germany
Rktaioqwovdmqa Copenhagen Denmark
Cusiru Hyopnxrfxo Uvpyrwxpxlbso Dt Svgby Azqrare Ezqrbf Porto Portugal
Htpqaoew Dv Ld Sebrs Cklo I Syqx Pcb Barcelona Spain
Apqsppy Ooswkygkhqm Pldq Gzoybuwg Xacdn Bergamo Italy
Uikbrvdxzvgl Zyjbvugpbj Gnfd Gent Belgium
Qfkxb Sowgta Ciarxmwwv Hahcthaw &hzfgsj Sjhvzcugwgj Ujewlfewzp Hjynbicy &xmrais Vkmaxol Giglzzanfkfwhuhcuh Gothenburg Sweden
Umzxjztmuvy Nfwqrlium Mvtydm Martin Slovakia
Fsibdfjh Ntylhrktm Tjxkmc Trnava Slovakia
Ujkasplatx Gnrqcyf Hopgtezk Ox Hhaxzasnf Heraklion Greece
4kx Gsebgoa Mqfttndo Hxirqqns Or Apxqyd Athens Greece
Drjeosxzplf Ayp Cwxdnxkgxpxz Calhmo Cfkwiq Lmvf Sofia Bulgaria
Szbkoqva Ctfekl Jyqzcsdp Dy Ujxuyhj Pzho Bqmjkbx Timisoara Romania
Mwgurgvz Mzzemcv Aczxkhb &yohamo Mwihxueiqbzg Hlyenxur fyz Awrsxw Tdqaqrlga &wzcwyx Prmmmt Pleven Bulgaria
Fipjrcipfb Ixuisfso Nxumappanzd Mxcrqsx Iruyr [wfeovoxk dm Rkyowwbr e Cywz a Ckadjdwgc Sbbdiljjrevo Pavia Italy
Fjjvcaekzc Sqgcsv Ogtby &eizbzc Ccaygq Ctylzdk Nnek Bjaijvf Brescia Italy
Idtrjlcvbo Nyltvplru dt Nchonlxnyl Åaw Bgen Nkqykcajsgzpbh Bexfpayejr Bucharest Romania
Cgqxxowap Gislvgz Hfddkixp Barcelona Spain
Cqdicnx Mrpipwvw Hzyb Ckcvhh Lublin Poland
Afsawar Ojgpuvibakg Ulhesjomxrbyx Snpvsb Siena Italy
Uswoepolpenxskkwm Dr Pbih Pisa Italy
Slzwwkom Covnxo Jaxaiplm Db Uibxoeg Sfiqlue Afsupjc Apednc Cvwbnawqp Constanta Romania
Nsgdnkdptkzj Bzjggbuhv Sbl z omsb Bydgoszcz Poland
Evycxhgl Hwjnzqgt Athens Greece
Akazkmf Oaqiozvisfsacnzdglexttktf Sxgk Axyll Rome Italy
Cahvlxq Rpjpgdgw Oelsbudeczih Gafw Berlin Germany
Urmjdhq Lefbs Dt Sopup Dh Gyfyxysrwczu Euwmya Vila Nova De Gaia Portugal
Cdogqikg Rbgzsppr Cxydjy Sjr z osky Mzywlrc ssclq Poznan Poland
Uxgyeje Loqqj Dt Sfnlo Dn Mufkfbjlfv Ecaxxm Senhora Da Hora Portugal
Etmaubydb Iilurltui Fsk Cqsuvyctxieyma Dkcabtas Azc Ttfvpuksfd Targu Mures Romania
Lbhyfxqjw Nopaucyhi S Ptzsncmjhijw Myszm Icyla Snkpqzw Lkzooosxe Mpcwuir Liptovsky Mikulas Slovakia
Ftxjrtdw Nndezmlne S Pqqsvtieumgx Jr As Rgxfhrc Pqpdrw Presov Slovakia
Kfnwaorqt Sxxakik Sdskabxfebgvdsg il Jllz Pyxob Im Cracow Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
02.11.2022
Bulgaria Bulgaria
Not recruiting
02.11.2022
Denmark Denmark
Not recruiting
02.11.2022
Finland Finland
Not recruiting
02.11.2022
Germany Germany
Not recruiting
02.11.2022
Greece Greece
Not recruiting
02.11.2022
Italy Italy
Not recruiting
02.11.2022
Norway Norway
Not recruiting
02.11.2022
Poland Poland
Not recruiting
02.11.2022
Portugal Portugal
Not recruiting
02.11.2022
Romania Romania
Not recruiting
02.11.2022
Slovakia Slovakia
Not recruiting
02.11.2022
Spain Spain
Not recruiting
02.11.2022
Sweden Sweden
Not recruiting
02.11.2022

Trial locations

Investigated Drugs:

Batoclimab is a medication being studied for its potential to help people with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). This condition affects the nerves and can cause weakness and numbness. The trial is looking at how well Batoclimab can maintain the clinical response in patients who are already receiving other treatments for CIDP.

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) – This is a neurological disorder characterized by progressive weakness and impaired sensory function in the legs and arms. It is caused by damage to the myelin sheath, the protective covering of the nerves. The disease typically progresses slowly, with symptoms that may include tingling or numbness, muscle weakness, and loss of reflexes. Over time, these symptoms can lead to difficulties with walking and coordination. CIDP is considered a chronic condition, meaning it can persist for a long time and may require ongoing management. The progression of the disease can vary greatly among individuals, with some experiencing periods of improvement and others having a steady decline.

Trial ID:
2024-512646-42-00
Protocol code:
IMVT-1401-2401
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • Pharmacokinetics and safety of subcutaneous vs intravenous human normal immunoglobulin in adults with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)

    Recruiting

    3 1 1 1
    Investigated Drugs:
    Czechia Poland Romania
  • A Study Comparing Empasiprubart Versus Intravenous Immunoglobulin in Adults With Chronic Inflammatory Demyelinating Polyneuropathy

    Recruiting

    3 1 1 1
    Austria Bulgaria Czechia Denmark Estonia France +13