UnknownPhase 1

Safety and Preliminary Clinical Activity of Itolizumab in Dermatomyositis

44 participantsStarted 2023-12-30

Plain-language summary

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

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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)

✕. 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;

Incidence of Treatment Emergent Adverse Events

Timeframe: Study Week 20

NCT IDNCT05986162

SponsorBiotech Pharmaceutical Co., Ltd.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-03

Xijuan Song

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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)

✕. 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;