TAK-411 for Chronic Inflammatory Demyelinating Polyradiculoneuropathy

(CASCA Trial)

Recruiting at 27 trial locations

Overseen By Takeda Contact

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Takeda

Must be taking: Immunoglobulin

Must not be taking: Immunosuppressants, Chemotherapy

Disqualifiers: CIDP variant, Neuropathy, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 21

Duration: 51 weeks

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called TAK-411, an experimental therapy for individuals with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP). In this condition, the immune system mistakenly attacks the protective coating of nerves. The trial aims to determine if TAK-411 can reduce inflammation and improve muscle strength and sensation. Participants will receive the treatment for up to a year and attend clinic visits to monitor progress. Suitable candidates are adults with CIDP who have previously responded to similar treatments and have experienced a recent worsening of symptoms. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to the development of a potentially effective therapy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be on a stable dose of immunoglobulin treatment. You cannot take certain immunosuppressive drugs or have had plasma exchange recently.

Is there any evidence suggesting that TAK-411 is likely to be safe for humans?

Research shows that TAK-411, a modified form of the protein immune globulin G (IG), is under study to determine its safety and effectiveness for treating Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP). Previous studies have found that treatments like TAK-411 are usually well-tolerated by patients. However, TAK-411 is currently in Phase 2 of clinical trials, and researchers are still learning about its full safety profile.

This phase tests the treatment on a larger group to better understand its safety. Although TAK-411 is still under investigation, similar treatments have been used safely for other conditions. So far, no serious side effects have been reported, but all potential treatments can carry some risks. Trial participants will be closely monitored to ensure their safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for CIDP?

Most treatments for Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) involve immunoglobulin therapy, corticosteroids, or plasmapheresis. However, TAK-411 stands out because it is administered through an intravenous infusion with a specific dosing schedule that starts with a higher induction dose. This approach might provide a more consistent therapeutic effect over time. Additionally, TAK-411's dosing regimen is structured to potentially offer quicker symptom relief, which could be a game changer in managing this chronic condition. Researchers are excited about TAK-411 because of its potential to offer a more targeted and possibly more effective treatment option for those with CIDP.

What evidence suggests that TAK-411 might be an effective treatment for CIDP?

Research shows that TAK-411, a modified form of the protein immune globulin G, might help treat CIDP by reducing inflammation and improving symptoms. Studies have found that treatments using immune globulin G effectively protect nerves from immune system attacks in CIDP. Early results suggest that TAK-411 enhances this protective effect, potentially leading to better nerve function and less muscle weakness. While researchers are still gathering specific data on TAK-411's effectiveness in humans, its design is based on proven methods that have helped CIDP patients in the past. ^{1 2 4 6 7}

Who Is on the Research Team?

Study Director

Principal Investigator

Takeda

Are You a Good Fit for This Trial?

Adults with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), a condition where the immune system attacks nerve coverings, leading to muscle weakness and sensory loss. Participants should have stable CIDP symptoms and be able to visit the clinic up to 21 times over a year.

Inclusion Criteria

I've had a positive response to IgG treatment for my neurological symptoms.

I have been diagnosed with CIDP by a specialist.

Participant has an INCAT score greater than 2 at screening

Exclusion Criteria

I have been diagnosed with a type of CIDP according to EAN/PNS 2021.

Participant has participated in another clinical study involving an IP or investigational device within 30 days before screening or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study

I have nerve damage not caused by cancer treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TAK-411 400 mg/kg IV infusion as an induction dose on Day 1, with possible repeat after 3 weeks if no clinical change, followed by 200 mg/kg every 3 weeks for 24 weeks, with an optional extension for an additional 27 weeks

51 weeks

Up to 21 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TAK-411

Trial Overview The trial is testing TAK-411, an altered form of immunoglobulin G derived from human plasma, designed to reduce inflammation and improve CIDP symptoms. It compares TAK-411's effects on physical functioning against historical placebo group data.

How Is the Trial Designed?

Group I: TAK-411 Experimental Treatment 1 Intervention

Participants will receive TAK-411 400 milligrams per kilogram (mg/kg), IV infusion as an induction dose on Day 1 of initial treatment period. The induction dose may be repeated once after 3 weeks if participants exhibit no clinical change. Thereafter, participants will receive TAK-411 200 mg/kg, IV infusion every 3 weeks for a total of 24 weeks (initial treatment period), followed by an optional additional 27 weeks (extended treatment period).

Who Is Running the Clinical Trial?

Takeda

Lead Sponsor

Trials

1,255

Recruited

4,219,000+

Dr. Naoyoshi Hirota

Takeda

Chief Medical Officer since 2020

MD from University of Tokyo

Christophe Weber

Takeda

Chief Executive Officer since 2015

PhD in Molecular Biology from Université de Montpellier

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06798012

NCT06798012 | A Study of TAK-411 in Adults With Chronic ... The main aim of this study is to check how TAK-411 affects the physical functioning of adults with CIDP when compared with results of the placebo group of a ...

2. rarediseaseadvisor.com rarediseaseadvisor.com/news/new-study-to-test-potential-cidp-treatment-opens/

New Study to Test Potential CIDP Treatment Opens A new phase 2 clinical trial to test the safety, efficacy, and tolerability of TAK-411 for the treatment of CIDP is now open.

3. clinicaltrials.takeda.com clinicaltrials.takeda.com/study-detail/95d6b5d68f4c4449?

TAK-411-2001 | Clinical Trial Summary This study will test if TAK-411 can decrease inflammation and improve symptoms of CIDP. The main aim of this study is to check how TAK-411 affects the physical ...

4. clinicaltrials.ucbraid.org clinicaltrials.ucbraid.org/trial/NCT06798012

A Study of TAK-411 in Adults With Chronic Inflammatory ... In CIDP, the immune system attacks the protective covering around the nerves called myelin. Over time, these nerves lose their ability to send signals to the ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8782785/

Clinical outcome of CIDP one year after start of treatment To assess clinical outcome in treatment-naive patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).

6. mayo.edu mayo.edu/research/clinical-trials/cls-20581972

Clinical Trials An Open-label Study to Investigate the Efficacy, Safety and Tolerability of TAK-411 in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy.

7. go.drugbank.com go.drugbank.com/conditions/DBCOND0030996

Chronic Inflammatory Demyelinating ... ... TAK-411 in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) ... Safety and Efficacy of Avonex in Subjects With Chronic Inflammatory ...