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NCT Number: NCT07554222

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

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.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

placebo

Baricitinib tablets

Drug

Baricitinib tablets

IBI3013

Drug

Recombinant anti-Interleukin-15 (IL-15) monoclonal antibody injection

Primary outcomes

  1. Part 1: Number of participants with at least one treatment-emergent adverse event

    Time frame: up to 24 weeks

  2. Part 1: Number of participants with at least one Serious treatment-emergent adverse event

    Time frame: up to 24 weeks

  3. Part 2: Number of participants with at least one treatment-emergent adverse event

    Time frame: up to 48 weeks

  4. Part 2: Number of participants with at least one Serious treatment-emergent adverse event

    Time frame: up to 48 weeks

Secondary outcomes

  1. Part 1: Cmax following a single dose of IBI3013.

    Time frame: up to 24 weeks

  2. Part 1: Tmax following a single dose of IBI3013.

    Time frame: up to 24 weeks

  3. Part 1: AUC following a single dose of IBI3013.

    Time frame: up to 24 weeks

  4. Part 1: Cmin following a single dose of IBI3013.

    Time frame: up to 24 weeks

  5. Part 1: CL/F or CL following a single dose of IBI3013.

    Time frame: up to 24 weeks

  6. Part 1: Vd/F or Vd following a single dose of IBI3013.

    Time frame: up to 24 weeks

  7. Part 1: T1/2 following a single dose of IBI3013.

    Time frame: up to 24 weeks

  8. Part 1: Positive rate of anti-drug antibody following a single dose of IBI3013.

    Time frame: up to Day85

  9. Part 2: Cmax following multiple doses of IBI3013.

    Time frame: up to 48 weeks

  10. Part 2: Tmax following multiple doses of IBI3013.

    Time frame: up to 48 weeks

  11. Part 2: AUC following multiple doses of IBI3013.

    Time frame: up to 48 weeks

  12. Part 2: Cmin following multiple doses of IBI3013.

    Time frame: up to 48 weeks

  13. Part 2: CL/F following multiple doses of IBI3013.

    Time frame: up to 48 weeks

  14. Part 2: Vd/F following multiple doses of IBI3013.

    Time frame: up to 48 weeks

  15. Part 2: T1/2 following multiple doses of IBI3013.

    Time frame: up to 48 weeks

  16. Part 2: Positive rate of anti-drug antibody following multiple doses of IBI3013.

    Time frame: up to 28 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

juan chen

CONTACT

[email protected]

021 3183 7200

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 28, 2026
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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