TAK-411 for Chronic Inflammatory Demyelinating Polyradiculoneuropathy

(CASCA Trial)

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

Trial Summary

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.

What is the purpose of this trial?

CIDP is an autoimmune disease. This means that the body's germ fighting (immune) system attacks itself. 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 muscles in the body. This leads to muscle weakness and loss of sensation in arms and legs among other symptoms. Participants with CIDP can be treated with a protein called immunoglobulin (or IG). TAK-411 is a special type of immune globulin G (hsIgG) that has been chemically changed. It is made from IG that comes from human plasma. 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 functioning of adults with CIDP when compared with results of the placebo group of a historical trial. Participants may be treated with TAK-411 for up to 1 year (51 weeks) and will be followed up for 3 weeks after last dose. During the study, participants may visit their study clinic up to approximately 21 times.

Research Team

Study Director

Principal Investigator

Takeda

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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