Safety and Preliminary Clinical Activity of Itolizumab in Dermatomyositis

NCT05986162 | Unknown Phase 1

• 1 other identifier: BPL-ITO-DM-1001
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the safety, tolerability, PK, PD, and preliminary clinical activity of Itolizumab in subjects with Dermatomyositis.

Conditions

Dermatomyositis, Adult Type

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment Emergent Adverse Events

  Number of subjects with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) V5.0

  Study Week 20

Secondary Outcomes (21)

• Maximum serum concentration of Itolizumab, Cmax

  Study Week 16

• Minimum serum concentration of Itolizumab, Cmin

  Study Week 16

• Time to maximum serum concentration of Itolizumab, Tmax

  Study Week 16

• Total Itolizumab exposure across time, AUC0-t

  Study Week 16

• Half life of Itolizumab, t1/2

  Study Week 16

Other Outcomes (1)

• Exploratory indicators

  Study Week 16

Study Arms (3)

Itolizumab Dose Level 1

EXPERIMENTAL

Itolizumab of 25 mg administered by intravenous infusion every 2 weeks for a total of 7 doses.

Drug: Itolizumab

Itolizumab Dose Level 2

EXPERIMENTAL

Itolizumab of 50 mg administered by intravenous infusion every 2 weeks for a total of 7 doses.

Drug: Itolizumab

Itolizumab Dose Level 3

EXPERIMENTAL

Itolizumab of 100 mg administered by intravenous infusion every 2 weeks for a total of 7 doses.

Drug: Itolizumab

Interventions

Itolizumab DRUG

Patients to be treated with Itolizumab.

Also known as: T1h

Itolizumab Dose Level 1; Itolizumab Dose Level 2; Itolizumab Dose Level 3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subject aged 18-75 years old (inclusive).
• Fulfill one of the following criteria for DM:1) Bohan and Peter criteria for definite or probable DM;2) ENMC 2018 Dermatomyositis Classification Criteria
• Disease activity fulfills at least three of the following criteria:1) MMT-8 score \< 142; 2) physician's global disease activity ≥2 cm; 3) patient's global activity ≥2 cm; 4) extra-muscular activity ≥2 cm; 5) Health Assessment Questionnaire \[HAQ\] ≥0.25; 6) at least one muscle enzyme \>1.5 times ULN
• Under treatment with corticosteroids and/or at least 1 immunesuppressant, and being on stable therapy for at least 4 and 8 weeks for corticosteroids and immunesuppressant respectively (see Section 5.7.1)
• Fulfill all of the following criteria: 1) % predicted values of FVC≥70%; 2) % predicted values of DLCO≥60%; 3) chest HRCT indicating the extent of disease lesion of DM-ILD \< 20% as determined by the investigator
• Negative result of serum HCG within 72 hours before enrollment for female with potential fertility
• Able to understand and comply with the planned procedure as required by the protocol, and sign a written informed consent form (ICF)

You may not qualify if:

• Subject with other connective tissue diseases (e.g., systemic sclerosis, systemic lupus erythematosus, rheumatoid arthritis, polyarteritis nodosa, Sjogren's syndrome, mixed connective tissue disease, etc.) or ANCA associated vasculitis.
• Diagnosed with polymyositis or IMNM.
• Diagnosed with systemic, severe musculoskeletal disorder that unrelated to DM and will interfere with the investigator's assessment of the subject's muscle strength.
• Subject who plans to start a physical therapy program during the trial.
• Subject who has a medical history of New York Heart Association class III or IV congestive heart failure, clinically significant or uncontrolled unstable angina or myocardial infarction, cerebrovascular accident, or pulmonary embolism within 6 months prior to screening
• Subject with impaired renal function (serum creatinine \> 1.5 x ULN or creatinine clearance \< 30 mL/min \[Cockcroft-Gault formula\]) at screening.
• Any of following significant abnormalities in liver function at screening:
• Serum alanine transaminase (ALT) or glutathione transaminase (AST) ≥ 3 x ULN, except when judged by the investigator to be due to DM;
• Total bilirubin ≥ 1.5 x ULN;
• Cirrhosis classification of Child-Pugh grade C.
• Any of the following abnormalities at screening:
• Hepatitis B-related tests: ① positive hepatitis B surface antigen (HBsAg); ② positive hepatitis B core antibody (HBcAb); ③ positive hepatitis B surface antibody (HBsAb) and no history of hepatitis B vaccination; ④ positive hepatitis B e antigen or hepatitis B e antibody;
• Positive hepatitis C virus nucleic acid test (HCV-RNA);
• Positive acquired immunodeficiency syndrome antibody (HIV-Ab);
• Positive anti-syphilis spiral antibody (TP-Ab);

Sponsors & Collaborators

• Biotech Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Dermatomyositis

Interventions

itolizumab

Condition Hierarchy (Ancestors)

Polymyositis; Myositis; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Xiaofeng Zeng

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

• Rui Chen

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xijuan Song

CONTACT

010-51571020; songxijuan@biotechplc.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: August 14, 2023
• Study Start: December 30, 2023
• Primary Completion: May 3, 2025
• Study Completion: June 25, 2025
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share