Health TrialsbyHealthPanel

Phase 2 Study to Evaluate EI-001 in Non-segmental Vitiligo Patients

ConditionNon-segmental Vitiligo
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorElixiron Immunotherapeutics (Hong Kong) Ltd.

About this trial

The primary purpose of this study is to evaluate whether the drug EI-001 can help improve vitiligo symptoms. EI-001 is a novel antibody drug that affects the immune system to decrease uncontrolled inflammation. EI-001 has been investigated in human cell cultures, animal studies, and in a Phase 1 healthy volunteer study. The results so far show that EI-001 is a tolerable and potential new treatment for immune diseases such as vitiligo.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Able to understand and voluntarily sign the informed consent form (ICF).

Male or female, aged 18-65 years at the time of consent.

Topical therapy (e.g., corticosteroids, calcineurin inhibitors, or JAK inhibitors) ≥ 3 months,

Phototherapy ≥ 6 months, or Oral therapy (e.g., corticosteroids, calcineurin inhibitors) ≥ 3 months.

Disqualifiers

Non-eligible skin conditions: Other types of vitiligo (e.g., segmental) or other depigmentation disorders (e.g., piebaldism, leprosy, post-inflammatory hypopigmentation, tinea versicolor, etc.), or ≥30% leukotrichia on face or body.

Psychiatric risk

Recent vitiligo treatments

Surgical treatments or depigmenting agents (e.g., monobenzone)

Trial design

Design model

Parallel

Treatments tested in this trial

  • EI-001

    Biological/Vaccine

    EI-001 drug product is supplied as a colorless to slightly yellow and sterile solution for infusion with a protein concentration of 10.0 mg/mL

  • Placebo

    Other intervention

    0.9% sterile sodium chloride solution

Treatment groups

45 Participants
are divided into 2 treatment groups
Group A: Drug: EI-001Experimental treatment 1 intervention
Group B: Drug: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percent change in F-VASI from baseline

Time frame
Week 24

Secondary outcomes

1

Proportion of subjects achieving F-VASI50

F-VASI50 is defined as at least 50% improvement in F-VASI from baseline

Time frame
Week 24
2

Frequency and severity of AEs and SAEs

Including the results of physical examinations, vital signs, evaluation of clinical laboratory studies, and ECG

Time frame
Week 32
3

Absolute values and percent change in F-VASI from baseline at designated time points

Time frame
Week 22
4

Absolute values and percent change in T-VASI from baseline at designated time points

Time frame
Week 22

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Elixiron Immunotherapeutics (Hong Kong) Ltd.

Lead sponsor

Source ClinicalTrials.gov
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