Low Dose IL-2 in the Treatment of Immune-associated ALS Syndrome

NCT04952155 | Unknown Phase 2 DMC

• 1 other identifier: M2020420
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to evaluate the efficacy and safety of low-dose IL-2 in the treatment of immunorelated ALS syndrome.

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

• ALSFRS-R score

  Changes in the rate of ALSFRS-R score during administration period compared with follow-up period

  week 0，week 24 and week 48

Secondary Outcomes (6)

• ALSFRS-R score

  week 0，week 24 and week 48

• ROADS score

  week 0，week 24 and week 48

• ALSAQ-40 score

  week 0，week 24 and week 48

• MRC score

  week 0，week 24 and week 48

• Immunological Responses

  week 0 and week 24

Study Arms (1)

IL-2

EXPERIMENTAL

The administration period was divided into 6 courses. 6 cycles of IL-2 were administered subcutaneously at a dose of 1 million IU every other day for 2 weeks, followed by a 2-week break in treatment.

Drug: IL-2

Interventions

IL-2 DRUG

The administration period was divided into 6 courses. 6 cycles of IL-2 were administered subcutaneously at a dose of 1 million IU every other day for 2 weeks, followed by a 2-week break in treatment. The adminstration course was 24 weeks.. The 24-week follow-up period was followed after the treatment.

IL-2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old;
• Clinically diagnosed with ALS syndrome, i.e., with ALS -like manifestations, consisting of a combination of upper and/or lower motor neuron damage;
• significant abnormalities with rheumatoid immune-related indicators, or diagnoses of immune-mediated ALS syndrome, including but not limited to multifocal motor neuropathy (MMN), Lewis-Sumner syndrome, and other ALS-like syndromes with an immune background that cannot be clearly classified;
• Poor treatment with conventional hormones or gamma globulin;
• Permitted concomitant treatment: oral prednisone or equivalent doses of other glucocorticoids (≤1.0mg/kg/d); Oral routine dose of immunosuppressants or immunomodulators, such as cyclophosphamide, tacrolimus, etc.; Routine oral doses such as too much force; Doses and types of accompanying therapeutic drugs should not be changed from the trial enrollment to the end of follow-up.
• For women of reproductive age, contraception for at least 2 weeks at the time of enrolment and negative urine HCG;
• Reasonable and effective contraceptive measures should be taken by subjects of childbearing age from the time of trial enrollment to the end of follow-up;
• Signed informed consent.

You may not qualify if:

• Allergic or intolerance to IL2;
• Receive non-standard treatment or use of excessive dose of glucocorticoids or gamma globulin intravenously within 2 months before enrollment;
• Vaccination within 6 months before enrolment or between enrolment and the end of follow-up;
• Peripheral venous white blood cells \< 2000/mm3, lymphocytes \< 600/mm3, platelets \< 80,000 /mm3;
• Complicated with severe infection or inflammation, such as bacteremia, sepsis, etc.;
• Complicated blood system diseases, infectious diseases (hepatitis, HIV, tuberculosis, etc.), mental diseases, dementia, severe hypotension, substance abuse history, malignant tumor history, organ transplantation history, etc.;
• Severe liver, kidney, lung or heart dysfunction: heart failure (≥NYHA grade III), renal insufficiency (creatinine clearance ≤30ml/min), abnormal liver function (3 times the upper limit of normal \>);
• Pregnant and lactating women;
• Currently participating in other clinical studies or using other investigational drugs.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100098, China

RECRUITING

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Interleukin-2

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Study Officials

• Dongsheng Fan

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dongsheng Fan

CONTACT

+86 13701023871; dsfan@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2021
• First Posted: July 7, 2021
• Study Start: January 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: August 18, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)