Study to Evaluate the Safety, Tolerability and How IBI3013 is Taken up and Processed by the Body in Healthy Volunteers After Single-dose Administration, and in Non-segmental Vitiligo Patients and Alopecia Areata Patients After Multiple-dose Administration

Official title

Evaluation of the Safety, Tolerability, and Pharmacokinetics of Single-dose Administration of IBI3013 in Healthy Adult Trial Participants and Multiple-dose Administration in Active Non-segmental Vitiligo Trial Participants and Severe Alopecia Areata Trial Participants - a Randomized, Double-blind, Placebo-controlled, Dose-escalation Study

Overview

A multicenter clinical study to evaluate the safety, PK characteristics, immunogenicity characteristics, and PD characteristics of IBI3013 in healthy trial participants and active non-segmental vitiligo trial participants and severe alopecia areata trial participants. The study is divided into 2 parts, with Part 1 involving healthy trial participants lasting up to 24 weeks, and Part 2 involving active non-segmental vitiligo trial participants and severe alopecia areata trial participants lasting up to 48 weeks.

Interventions

• Drug placebo
  placebo
• Drug Baricitinib tablets
  Baricitinib tablets
• Drug IBI3013
  Recombinant anti-Interleukin-15 (IL-15) monoclonal antibody injection

Primary outcome measures

• Part 1: Number of participants with at least one treatment-emergent adverse event [Time frame: up to 24 weeks]
• Part 1: Number of participants with at least one Serious treatment-emergent adverse event [Time frame: up to 24 weeks]
• Part 2: Number of participants with at least one treatment-emergent adverse event [Time frame: up to 48 weeks]
• Part 2: Number of participants with at least one Serious treatment-emergent adverse event [Time frame: up to 48 weeks]

Secondary outcome measures (12)

• Part 1: Cmax following a single dose of IBI3013. [Time frame: up to 24 weeks]
• Part 1: Tmax following a single dose of IBI3013. [Time frame: up to 24 weeks]
• Part 1: AUC following a single dose of IBI3013. [Time frame: up to 24 weeks]
• Part 1: Cmin following a single dose of IBI3013. [Time frame: up to 24 weeks]
• Part 1: CL/F or CL following a single dose of IBI3013. [Time frame: up to 24 weeks]
• Part 1: Vd/F or Vd following a single dose of IBI3013. [Time frame: up to 24 weeks]
• Part 1: T1/2 following a single dose of IBI3013. [Time frame: up to 24 weeks]
• Part 1: Positive rate of anti-drug antibody following a single dose of IBI3013. [Time frame: up to Day85]
• Part 2: Cmax following multiple doses of IBI3013. [Time frame: up to 48 weeks]
• Part 2: Tmax following multiple doses of IBI3013. [Time frame: up to 48 weeks]
• Part 2: AUC following multiple doses of IBI3013. [Time frame: up to 48 weeks]
• Part 2: Cmin following multiple doses of IBI3013. [Time frame: up to 48 weeks]

Eligibility criteria

Inclusion criteria

• Part 1 - Healthy trial participants: Understand and voluntarily sign the informed consent form;
• Part 1 - Healthy trial participants: Age between 18-45 years (inclusive), male or female;
• Part 1 - Healthy trial participants: Weight between 50-120 kg (inclusive), and BMI between 17.0-28.0 kg/m2 (inclusive);
• Part 2 - Active non-segmental vitiligo trial participants: 18-65 years old (inclusive), male;
• Part 2 - Active non-segmental vitiligo trial participants: Diagnosed with non-segmental vitiligo for ≥3 months and <2 years;
• Part 2 - Active non-segmental vitiligo trial participants: Total affected BSA 3-50%, and facial affected BSA ≥ 0.5%; T-VASI 3-50 (inclusive), and F-VASI ≥0.5; ≥1 active lesion;
• Part 2 - : Male participants of reproductive potential agree to use highly effective contraception and avoid sperm donation for 6 months after the last dose.
• Part 2 - Severe alopecia areata trial participants: 18-60 years old (inclusive), male;
• Part 2 - Severe alopecia areata trial participants: Meet the following severe alopecia areata criteria: a) SALT ≥50% (i.e., AA-IGA 3-4 grade) b) No spontaneous remission in the past 6 months (spontaneous remission defined as SALT reduction by ?10 points) c) Current duration of severe alopecia areata ≥6 months and <4 years;
• All participants: Participants of reproductive potential agree to use highly effective contraception and avoid sperm or egg donation for 6 months after the last dose.

Exclusion criteria

• All participants: Those who are allergic to any component of IBI3013;
• All participants: Those who cannot tolerate subcutaneous injection;
• All participants: History of live or attenuated live vaccine within 30 days prior to randomization, or expected to receive such vaccines during the study period until 3 months after the last dose of the investigational drug;
• All participants: Donated blood or lost ≥400 mL of blood within 3 months before screening;
• All participants: History of herpes zoster or disseminated herpes simplex (single episode), or recurrent (more than one episode) localized herpes zoster;
• All participants: Known history of active tuberculosis or clinical manifestations suggestive of tuberculosis, or positive interferon-gamma release assay unsuitable for participation;
• All participants: Abnormal vital signs, serum virology tests, laboratory tests, ECG, or other examinations with clinical significance, and deemed unsuitable for the study by the investigator;
• All participants: Received specific treatment within the time frame specified in the protocol, or participated in other investigational drug studies within the specified time;
• All participants: History of drug abuse, drug dependence, or positive drug screening results during the screening period within 12 months;
• All participants: Pregnant or lactating women;
• All participants: Coexisting diseases at screening or previously, deemed unsuitable for clinical trials;
• Active non-segmental vitiligo/Severe alopecia areata trial participants: Previous or coexisting diseases, which may affect the efficacy or safety evaluation of the study as assessed by the investigator;
• Active non-segmental vitiligo trial participants: Coexisting segmental, undetermined type, or mixed-type vitiligo, or other skin pigmentation disorders, or other skin-related abnormalities that may affect the assessment of the study;
• Severe alopecia areata trial participants: Currently diagnosed with primary diffuse AA or ophiasis AA; or other types of hair loss that may interfere with AA evaluation;
• Severe alopecia areata trial participants: Previously received oral JAK inhibitors with poor response; 16. Severe alopecia areata trial participants: Acute myocardial infarction, unstable ischemic heart disease, stroke, chronic heart failure (NYHA class III/IV) within 12 weeks prior to screening; or previous history of deep vein thrombosis, or high risk of deep vein thrombosis as assessed by the investigator; or severe neuropsychiatric disorder, deemed unsuitable for the study by the investigator.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 1 center

• Huashan Hospital, Fudan University — Shanghai

Identifiers

NCT: NCT07554222 · CIBI3013A101

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗