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Dermatomyositis, Adult TypePhase 1NCT05986162

Safety and Preliminary Clinical Activity of Itolizumab in Dermatomyositis

A Phase 1 study testing Itolizumab in people with Dermatomyositis, Adult Type, run by Biotech Pharmaceutical Co., Ltd..

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To evaluate the safety, tolerability, PK, PD, and preliminary clinical activity of Itolizumab in subjects with Dermatomyositis. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Dermatomyositis, Adult Type
What is being tested?
Itolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
No sites listed yet
Study dates
30 Dec 2023to 25 Jun 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.
Show all 30Show fewer
  • 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);
  • Other acute or chronic infections requiring treatment.
  • Absolute lymphocyte count < 0.5×109/L at screening
  • Subject who has a medical history of tuberculosis or those who deny a history of tuberculosis but has a positive gamma-interferon release test at screening.
  • Any other clinically significant clinical condition or laboratory tests abnormality that, in the judgment of the investigator, may affect the safety evaluation
  • Any malignant tumor other than the cured carcinoma in situ or basal cell carcinoma within 5 years before screening
  • Suspected allergic to the investigational drug or any of its excipients
  • Subject who had participated in other clinical studies (other than those not receiving interventions, such as observational study or questionnaires survey) within 3 months prior to screening, or who are participating in other experimental treatments.
  • Subject who requires to be administrated with higher dose of corticosteroids and/or immunesuppressant than the allowed maximum dose specified in the protocol (section 5.7.1)
  • Subject who had been treated by one or more of the following drugs during the corresponding time window prior to screening:
  • cyclophosphamide, rituximab within 12 months prior to screening;
  • belizumab, tetrasip within 24 weeks prior to screening;
  • intravenous immunoglobulin injections, baliximab, infliximab, adalimumab, tolimumab, JAK inhibitors within 12 weeks prior to screening;
  • Other monoclonal antibodies or other biological agents within 12 weeks or 5 half-lives [whichever is longer] prior to screening.
  • Currently pregnant, breastfeeding,or planning to become pregnant or not using reliable method to avoid pregnancy during study and within 3 months after the last study treatment
  • As determined by the investigator, any medical, psychiatric, or other condition or circumstance that is likely to negatively affect the reliability of the study data.

Trial locations and contacts

No sites are listed yet.

Xijuan Song contact

010-51571020

songxijuan@biotechplc.com

About this study

Official title: A Phase 1 Study to Evaluate the Safety, Tolerability and Preliminary Clinical Activity of Itolizumab in Subjects With Dermatomyositis

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

Read the detailed description

The study will enroll approximately 44 subjects in two parts:

Part 1 is an open label, 3+3 single dose escalation and then mutiple dose administration phase. 9~30 patients with DM are expected to be enrolled across 3 dose cohorts.

Part 2 is a randomized phase and will enroll approximately 14 additional subjects, randomized in a 1:1 ratio to one of the 2 doses based on efficacy data obtained from Part 1. All participants in this study will receive Itolizumab intravenously every two weeks for a total of 7 doses.

Being tested
Itolizumab
Medical subject headings
Dermatomyositis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ItolizumabDrug

    Also called T1h

    Patients to be treated with Itolizumab.

Study groups in NCT05986162
Study groupRoleWhat they receive
Itolizumab Dose Level 1ExperimentalItolizumab of 25 mg administered by intravenous infusion every 2 weeks for a total of 7 doses.
Receives: Drug: Itolizumab
Itolizumab Dose Level 2ExperimentalItolizumab of 50 mg administered by intravenous infusion every 2 weeks for a total of 7 doses.
Receives: Drug: Itolizumab
Itolizumab Dose Level 3ExperimentalItolizumab of 100 mg administered by intravenous infusion every 2 weeks for a total of 7 doses.
Receives: Drug: Itolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Study Week 20

Secondary outcomes (21)

  1. Maximum serum concentration of Itolizumab, Cmax

    Maximum serum concentration of Itolizumab

    Measured: Study Week 16

  2. Minimum serum concentration of Itolizumab, Cmin

    Minimum serum concentration of Itolizumab

    Measured: Study Week 16

  3. Time to maximum serum concentration of Itolizumab, Tmax

    Time to maximum serum concentration of Itolizumab

    Measured: Study Week 16

  4. Total Itolizumab exposure across time, AUC0-t

    Total Itolizumab exposure across time

    Measured: Study Week 16

  5. Half life of Itolizumab, t1/2

    Half life of Itolizumab

    Measured: Study Week 16

  6. IL-2

    Inflammatory Markers：IL-2

    Measured: Study Week 16

  7. IL-6

    Inflammatory Markers:IL-6

    Measured: Study Week 16

  8. TNF-α

    Inflammatory Markers: TNF-α

    Measured: Study Week 16

  9. IFN-γ

    Inflammatory Markers:IFN-γ

    Measured: Study Week 16

  10. CRP

    Inflammatory Markers:CRP

    Measured: Study Week 16

  11. Serum ferritin

    Inflammatory Markers:Serum ferritin

    Measured: Study Week 16

  12. ESR

    Inflammatory Markers:ESR

    Measured: Study Week 16

  13. IgG

    Inflammatory Markers：IgG

    Measured: Study Week 16

  14. IgM

    Inflammatory Markers：IgM

    Measured: Study Week 16

  15. IgA

    Inflammatory Markers： IgA

    Measured: Study Week 16

  16. CD6 receptor expression levels

    Mean change of CD6 receptor expression levels in relative to baseline

    Measured: Study Week 16

  17. T cell subsets

    Mean change of different proportion of T cell subsets in relative to baseline

    Measured: Study Week 16

  18. Proportion of patients achieving a TIS of ≥20

    Defined as patients with an increase of ≥20 points on the Total Improvement Score in relative to baseline.

    Measured: Study Week 16

  19. Proportion of patients achieving DOI

    DOI defined as ≥ 20% improvement in 3 of any 6 core set measures, with no more than 2 core set measures worsening by ≥ 25% (MMT-8 cannot worsen by ≥ 25%).

    Measured: Study Week 16

  20. Mean Change of Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) activity score

    Defined as the mean change of activity score of CDASI（Score Range：0~132，The hingher score indcates the worse outcome） relative to baseline.

    Measured: Study Week 16

  21. Incidence of ADA

    Defined as the precentage of subjects presenting anti-drug antibody

    Measured: Study Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2023
  2. Study start30 Dec 2023 (estimated)
  3. Primary completion3 May 2025 (estimated)
  4. Study completion25 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05986162
Sponsor's protocol ID
BPL-ITO-DM-1001
Status last verified
Aug 2023
First submitted
20 Jul 2023
Last updated
14 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Itolizumab in people with Dermatomyositis, Adult Type, run by Biotech Pharmaceutical Co., Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xijuan Song (010-51571020, songxijuan@biotechplc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment Emergent Adverse Events (time frame: Study Week 20). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05986162.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.

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