VitiligoPhase 1NCT06625177
A Trial to Test the Safety and Efficacy of TEV-53408 in Participants With Vitiligo
A Phase 1 study testing TEV-53408 in people with Vitiligo, run by Teva Branded Pharmaceutical Products R&D LLC at 13 sites in United States.
Trial summary
The purpose of the trial is to evaluate the safety of TEV-53408 when given as an under the skin injection to adults with vitiligo. Vitiligo is a condition where patches of skin lose color (pigment) and turn white. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Vitiligo
- What is being tested?
- TEV-53408
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 13 sitesUnited States
- Study dates
- 11 Nov 2024to 31 Jan 2029
- Phase
- Phase 1
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The participant has a diagnosis of active or stable vitiligo for at least 3 months.
- The participant has a body mass index (BMI) within the range of 18.5 to 40.0 kg/m2
- A female participant is eligible if she is not pregnant or breastfeeding AND is a woman of nonchildbearing potential OR is a women of childbearing potential using a contraceptive method that is highly effective AND agrees not to donate eggs for the purpose of reproduction for the required period
- A male participant is eligible if he agrees to refrain from donating sperm PLUS remain abstinent from heterosexual intercourse OR use a male condom with a female partner for the required period
- The participant is capable of giving signed, informed consent
- The participant agrees to discontinue all agents and procedures used to treat vitiligo during the treatment period in the trial
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- If receiving permitted concomitant medications for any reason other than vitiligo, the participant must be on a stable regimen,
- The participant must agree to avoid prolonged exposure to the sun, must use sunscreen, and must not use tanning booths, sun lamps, or other ultraviolet light sources
- NOTE - Additional criteria apply, please contact the investigator for more information
Who cannot join
- The participant suffers from vitiligo induced by exposure to chemicals or immunotherapy known to induce vitiligo
- The participant has other autoimmune diseases for which systemic immunotherapy is or may be warranted
- The participant has current or history of malignancy or treatment of malignancy in the last 5 years, excluding fully-treated basal cell carcinoma
- Infectious disease
- The participant has used skin bleaching treatments for past treatment of vitiligo or other pigmented areas
- The participant has a history of melanocyte-keratinocyte transplantation procedure or other surgical treatment for vitiligo. After 2 or more years since last melanocyte-keratinocyte transplantation procedure, the participants may be included in the trial.
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- The participant has donated or received any blood or blood products (white blood cells, platelets, etc) within the 60 days prior to screening or has donated blood or blood products on 2 or more occasions within the 6 months prior to IMP administration, or has donated plasma within 7 days before the screening visit, or has planned donations during the trial
- The participant has current or history of alcohol or other substance abuse
- NOTE- Additional criteria apply, please contact the investigator for more information
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
United States13 sites, 3 recruiting
- Active, not recruiting
Teva Investigational Site 12048
Canton, Michigan, 48187
- Active, not recruiting
Teva Investigational Site 12047
Chicago, Illinois, 60614
- Active, not recruiting
Teva Investigational Site 12045
Dallas, Texas, 75230
- Recruiting
Teva Investigational Site 12044
Fremont, California, 94538
- Recruiting
Teva Investigational Site 12052
Hot Springs, Arkansas, 71913
- Active, not recruiting
Teva Investigational Site 12051
Irvine, California, 92617
- Active, not recruiting
Teva Investigational Site 12053
Louisville, Kentucky, 40421
- Active, not recruiting
Teva Investigational Site 12049
Miramar, Florida, 33025
- Active, not recruiting
Teva Investigational Site 12046
Pasadena, California, 91101
- Recruiting
Teva Investigational Site 12054
Portland, Oregon, 97210
- Terminated
Teva Investigational Site 12043
Scottsdale, Arizona, 85260
- Active, not recruiting
Teva Investigational Site 12055
South Jordan, Utah, 84095
- Active, not recruiting
Teva Investigational Site 12057
Webster, Texas, 77598
About this study
Official title: A Phase 1b, Open-Label Trial to Assess Safety and Exploratory Efficacy of TEV-53408 in Participants With Vitiligo
The purpose of the trial is to evaluate the safety of TEV-53408 when given as an under the skin injection to adults with vitiligo. Vitiligo is a condition where patches of skin lose color (pigment) and turn white.
- Conditions
- Vitiligo
- Being tested
- TEV-53408
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEV-53408Drug
TEV-53408 injection administered subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Dose A Receives: Drug: TEV-53408 |
| Cohort 2 | Experimental | Dose A Receives: Drug: TEV-53408 |
| Cohort 3 | Experimental | Dose B Receives: Drug: TEV-53408 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With at Least One Treatment-Emergent Adverse Event
Measured: Up to Week 40
Number of Participants With at Least One Serious Treatment-Emergent Adverse Event
Measured: Up to Week 40
Number of Participants With at Least One Protocol-Defined Adverse Event of Special Interest
Measured: Up to Week 40
Number of Participants With at Least One Treatment-Related Adverse Event
Measured: Up to Week 40
Number of Participants who Discontinued Treatment due to an Adverse Event
Measured: Up to Week 40
Secondary outcomes (1)
Number of Participants With at Least One Protocol-Defined Adverse Event of Special Interest
Measured: Week 40 to Week 80
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start11 Nov 2024
- Primary completion26 Apr 2028 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Teva Medical Expert, MD, Study director, Teva Branded Pharmaceutical Products R&D LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06625177
- Sponsor's protocol ID
- TV53408-IMM-10209
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2024
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be assessed for scientific merit, product approval status, and conflicts of interest. If the request is approved, patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.