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VitiligoPhase 1/2GREVITNCT07647237

A Clinical Trial of Multiple Doses of GR2301 Injection Combined With Phototherapy in Trial Participants With Vitiligo

A Phase 1/2 study testing GR2301 injection in people with Vitiligo, run by Genrix (Shanghai) Biopharmaceutical Co., Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is a randomized, double-blind, placebo-controlled Phase Ib/II clinical trial of multiple subcutaneous injections of GR2301 in combination with phototherapy to evaluate the tolerability, safety, pharmacokinetics, and preliminary efficacy in trial participants with vitiligo. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Vitiligo
What is being tested?
GR2301 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
116 participants
Where
No sites listed yet
Study dates
Jun 2026to Dec 2028
Phase
Phase 1/2
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Main Inclusion Criteria:

  1. Meet the clinical diagnosis of non-segmental vitiligo at screening visit and baseline visit, and meet the following criteria: clinical diagnosis of non-segmental vitiligo for at least 3 months at screening visit; facial affected BSA ≥0.5% and total body affected BSA ≥3% at screening visit and baseline visit; F-VASI and T-VASI scores meet the criteria at screening visit and baseline visit.
  2. Able to understand and comply with the requirements of the clinical protocol, voluntarily participate in the clinical trial, and provide signed written informed consent by the trial participant or their legally authorized representative.

Main Exclusion Criteria:

  1. Vitiligo-related medical conditions and other dermatologic diseases/conditions.
  2. Prior permanent tattooing or grafting within the vitiligo lesions.
  3. Have absolute contraindications to phototherapy; or have relative contraindications to phototherapy (as comprehensively judged by the investigator).
  4. Are unwilling or unable to comply with the permitted and prohibited concomitant medications/treatment specifications of this trial, and cannot meet the protocol-required washout period for medications/treatments prior to randomization.
  5. Have a serious underlying disease that, in the investigator's opinion, may pose a safety risk to the trial participant if enrolled in the clinical trial.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

liaison officer contact

021-50805988-8039

shuxueye@genrixbio.com

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Phase Ib/II Clinical Trial of Multiple Subcutaneous Injections of GR2301 in Combination With Phototherapy to Evaluate the Tolerability, Safety, Pharmacokinetics, and Preliminary Efficacy in Trial Participants With Vitiligo

This is a randomized, double-blind, placebo-controlled Phase Ib/II clinical trial of multiple subcutaneous injections of GR2301 in combination with phototherapy to evaluate the tolerability, safety, pharmacokinetics, and preliminary efficacy in trial participants with vitiligo. The trial will be conducted in two stages: a dose-escalation stage (Phase Ib) and an expansion cohort stage (Phase II).

Conditions
Vitiligo
Being tested
GR2301 injection, Placebo
Keywords
IL15
Medical subject headings
Vitiligo

What participants receive

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

  • GR2301 injectionBiological

    IL15 monoclonal antibody

  • PlaceboBiological

    Placebo

Study groups in NCT07647237
Study groupRoleWhat they receive
GR2301 injection dose1/PlaceboExperimentalNot described
Receives: Biological: GR2301 injection
GR2301 injection dose2/PlaceboExperimentalNot described
Receives: Biological: GR2301 injection
GR2301 injection dose3/PlaceboExperimentalNot described
Receives: Biological: GR2301 injection
GR2301 injection dose4ExperimentalNot described
Receives: Biological: GR2301 injection
GR2301 injection dose5ExperimentalNot described
Receives: Biological: GR2301 injection
GR2301 injection dose6ExperimentalNot described
Receives: Biological: GR2301 injection
PlaceboPlacebo comparatorNot described
Receives: Biological: Placebo

What is being measured

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

  1. Adverse events (AEs)( Phase Ib）

    Incidence of adverse events

    Measured: up to 52weeks

  2. Proportion of subjects achieving F-VASI 75(Phase II)

    VASI(vitiligo area scoring index) is a clinician-reported outcome used to assess the affected body surface area and the degree of depigmentation. F-VASI represents the assessment of facial vitiligo lesions. F-VASI75 means percentage of subjects with at least a 75% decrease from baseline in F-VASI. The higher the VASI score, the more severe the skin lesion.

    Measured: Week 24

Secondary outcomes (8)

  1. Change from baseline and percent change from baseline in F-VASI/T-VASI

    VASI(vitiligo area scoring index) is a clinician-reported outcome used to assess the affected body surface area and the degree of depigmentation. F-VASI represents the assessment of facial vitiligo lesions, and T-VASI represents the assessment of total body vitiligo lesions. The higher the VASI score, the more severe the skin lesion.

    Measured: Week 24、36、48、52

  2. Proportion of subjects achieving F/T-VASI 35, 50, and 75

    VASI(vitiligo area scoring index) is a clinician-reported outcome used to assess the affected body surface area and the degree of depigmentation. F-VASI represents the assessment of facial vitiligo lesions, and T-VASI represents the assessment of total body vitiligo lesions. The higher the VASI score, the more severe the skin lesion. F/T-VASI 35, 50, and 75 represent at least a 35%, 50%, or 75% reduction from baseline in either F-VASI or T-VASI.

    Measured: Week 24、36、48、52

  3. Percent change from baseline in facial body surface area (F-BSA) and total body surface area (T-BSA) affected by vitiligo

    Measured: Week 24、36、48、52

  4. Proportion of subjects achieving a score of 0 or 1 on the Facial Physician's Global Vitiligo Assessment (F-PhGVA) and the Total Physician's Global Vitiligo Assessment (T-PhGVA)

    The severity of Facial Physician's Global Vitiligo Assessment (F-PhGVA) and the Total Physician's Global Vitiligo Assessment (T-PhGVA) will be assessed separately by the study physician using the PhGVA, both on a 5-point scale ranging from 0 (clear) to 4 (severe).

    Measured: Week 24、36、48、52

  5. Proportion of subjects achieving a score of 4 or 5 on the Vitiligo Noticeability Scale (VNS)

    The Vitiligo Noticeability Scale (VNS) is a patient-reported outcome measure of treatment success for vitiligo, using a 5-point scale, where a score of 4 or 5 can be defined as treatment success.

    Measured: Week 24、36、48、52

  6. Proportion of subjects achieving a score of 1 or 2 on the Facial Patient Global Impression of Change for Vitiligo (F-PaGIC-V) and the Total Patient Global Impression of Change for Vitiligo (T-PaGIC-V)

    The Patient Global Impression of Change-Vitiligo (PaGIC-V) is a self-assessment by trial participants of the improvement in facial vitiligo (F-PaGIC-V) and total body vitiligo (T-PaGIC-V), using a 7-point scale, where a PaGIC-V score of 1 or 2 can be defined as treatment success.

    Measured: Week 24、36、48、52

  7. Incidence of Anti-Drug Antibodys (ADAs)

    Measured: up to 52weeks

  8. drug concentration

    Measured: up to 52 weeks

Timeline

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

  1. First posted15 Jun 2026
  2. Study startJun 2026 (estimated)
  3. Primary completionJun 2028 (estimated)
  4. Study completionDec 2028 (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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
116 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07647237
Sponsor's protocol ID
GR2301-002
Acronym
GREVIT
Status last verified
May 2026
First submitted
25 May 2026
Last updated
15 Jun 2026
Results posted
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 1/2 study testing GR2301 injection in people with Vitiligo, run by Genrix (Shanghai) Biopharmaceutical Co., Ltd..

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

Who may be eligible to take part?

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: opening soon, as of the sponsor's last update on 15 Jun 2026. 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. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 liaison officer (021-50805988-8039, shuxueye@genrixbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (AEs)( Phase Ib） (time frame: up to 52weeks). The study lists 2 primary outcomes in all. 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 NCT07647237.

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 15 Jun 2026.

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