New antibody drug aims to halt skin and hair loss
NCT ID NCT07554222
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tests a new drug called IBI3013, which blocks a protein (IL-15) involved in immune attacks. It includes 160 people: healthy volunteers first, then people with active vitiligo or severe alopecia areata. The main goal is to check safety and how the drug moves through the body, not yet whether it works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- IBI3013 (an antibody that blocks IL-15, a protein involved in immune attacks)
- What this could lead to
- If it works, this could point toward a new treatment for vitiligo and alopecia areata by calming the immune system.
- What could go wrong
- This is a very early Phase 1 trial focused on safety and dosing, not on effectiveness. It may not work or could have side effects. Results are years away.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 160 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria 1. Part 1 - Healthy trial participants: Understand and voluntarily sign the informed consent form; 2. Part 1 - Healthy trial participants: Age between 18-45 years (inclusive), male or female; 3. Part 1 - Healthy trial participants: Weight between 50-120 kg (inclusive), and BMI between 17.0-28.0 kg/m2 (inclusive); 4. Part 2 - Active non-segmental vitiligo trial participants: 18-65 years old (inclusive), male; 5. Part 2 - Active non-segmental vitiligo trial participants: Diagnosed with non-segmental vitiligo for ≥3 months and \<2 years; 6. 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; 7. Part 2 - : Male participants of reproductive potential agree to use highly effective contraception and avoid sperm donation for 6 months after the last dose. 8. Part 2 - Severe alopecia areata trial participants: 18-60 years old (inclusive), male; 9. 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; 10. 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 1. All participants: Those who are allergic to any component of IBI3013; 2. All participants: Those who cannot tolerate subcutaneous injection; 3. 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; 4. All participants: Donated blood or lost ≥400 mL of blood within 3 months before screening; 5. All participants: History of herpes zoster or disseminated herpes simplex (single episode), or recurrent (more than one episode) localized herpes zoster; 6. All participants: Known history of active tuberculosis or clinical manifestations suggestive of tuberculosis, or positive interferon-gamma release assay unsuitable for participation; 7. 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; 8. All participants: Received specific treatment within the time frame specified in the protocol, or participated in other investigational drug studies within the specified time; 9. All participants: History of drug abuse, drug dependence, or positive drug screening results during the screening period within 12 months; 10. All participants: Pregnant or lactating women; 11. All participants: Coexisting diseases at screening or previously, deemed unsuitable for clinical trials; 12. 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; 13. 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; 14. 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; 15. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Huashan Hospital, Fudan University
RECRUITINGShanghai, Shanghai Municipality, China
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