HealthyPhase 1NCT07554222
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 Phase 1 study testing Baricitinib tablets and IBI3013 in people with Healthy and Active Non-segmental Vitiligo, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Active Non-segmental Vitiligo, Severe Alopecia Areata
- What is being tested?
- Baricitinib tablets and IBI3013
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 18 Apr 2026to 31 Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality
Jing Zhang, 021-54602070, Zhangj_fudan@163.com
Wenyu Wu, 021-54602070, wwylcsy@163.com
About this study
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
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.
- Being tested
- placebo, Baricitinib tablets, IBI3013
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
placebo
Baricitinib tabletsDrug
Baricitinib tablets
IBI3013Drug
Recombinant anti-Interleukin-15 (IL-15) monoclonal antibody injection
| Study group | Role | What they receive |
|---|---|---|
| Baricitinib tablets | Active comparator | oral, 2mg, once daily Receives: Drug: Baricitinib tablets |
| placebo | Placebo comparator | subcutaneous injection/intravenous infusion,single or multiple dosing Receives: Drug: placebo |
| IBI3013 | Experimental | subcutaneous injection/intravenous infusion,single or multiple dosing Receives: Drug: IBI3013 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Number of participants with at least one treatment-emergent adverse event
Measured: up to 24 weeks
Part 1: Number of participants with at least one Serious treatment-emergent adverse event
Measured: up to 24 weeks
Part 2: Number of participants with at least one treatment-emergent adverse event
Measured: up to 48 weeks
Part 2: Number of participants with at least one Serious treatment-emergent adverse event
Measured: up to 48 weeks
Secondary outcomes (16)
Part 1: Cmax following a single dose of IBI3013.
Measured: up to 24 weeks
Part 1: Tmax following a single dose of IBI3013.
Measured: up to 24 weeks
Part 1: AUC following a single dose of IBI3013.
Measured: up to 24 weeks
Part 1: Cmin following a single dose of IBI3013.
Measured: up to 24 weeks
Part 1: CL/F or CL following a single dose of IBI3013.
Measured: up to 24 weeks
Part 1: Vd/F or Vd following a single dose of IBI3013.
Measured: up to 24 weeks
Part 1: T1/2 following a single dose of IBI3013.
Measured: up to 24 weeks
Part 1: Positive rate of anti-drug antibody following a single dose of IBI3013.
Measured: up to Day85
Part 2: Cmax following multiple doses of IBI3013.
Measured: up to 48 weeks
Part 2: Tmax following multiple doses of IBI3013.
Measured: up to 48 weeks
Part 2: AUC following multiple doses of IBI3013.
Measured: up to 48 weeks
Part 2: Cmin following multiple doses of IBI3013.
Measured: up to 48 weeks
Part 2: CL/F following multiple doses of IBI3013.
Measured: up to 48 weeks
Part 2: Vd/F following multiple doses of IBI3013.
Measured: up to 48 weeks
Part 2: T1/2 following multiple doses of IBI3013.
Measured: up to 48 weeks
Part 2: Positive rate of anti-drug antibody following multiple doses of IBI3013.
Measured: up to 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start18 Apr 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07554222
- Sponsor's protocol ID
- CIBI3013A101
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07554222
- Acronym / sponsor ID
- CIBI3013A101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Apr 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 28 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Baricitinib tablets | Active comparator | Drug: Baricitinib tabletsoral, 2mg, once daily |
| placebo | Placebo comparator | Drug: placebosubcutaneous injection/intravenous infusion,single or multiple dosing |
| IBI3013 | Experimental | Drug: IBI3013subcutaneous injection/intravenous infusion,single or multiple dosing |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placeboplacebo | Drug | placebo |
| Baricitinib tabletsBaricitinib tablets | Drug | Baricitinib tablets |
| IBI3013Recombinant anti-Interleukin-15 (IL-15) monoclonal antibody injection | Drug | IBI3013 |
Primary outcome
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
16 secondary outcomes
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
Part 2: CL/F following multiple doses of IBI3013.
Time frame: up to 48 weeks
Part 2: Vd/F following multiple doses of IBI3013.
Time frame: up to 48 weeks
Part 2: T1/2 following multiple doses of IBI3013.
Time frame: up to 48 weeks
Part 2: Positive rate of anti-drug antibody following multiple doses of IBI3013.
Time frame: up to 28 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Baricitinib tablets and IBI3013 in people with Healthy and Active Non-segmental Vitiligo, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
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 10 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact juan chen (021 3183 7200, juan.chen01@innoventbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Number of participants with at least one treatment-emergent adverse event (time frame: up to 24 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Apr 2026.