Clinical trial NCT06625177: A Trial to Test the Safety and Efficacy of TEV-53408 in Treating Vitiligo
Official title: A Phase 1b, Open-Label Trial to Assess Safety and Exploratory Efficacy of TEV-53408 in Participants With Vitiligo
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Vitiligo
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2024-10-03
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of the trial is to evaluate the safety of TEV-53408 administered subcutaneously for the treatment of adults with vitiligo.

A secondary objective is to further evaluate the safety of TEV-53408.

The planned study period per participant is 84 weeks including a screening period (up to 4 weeks), a 24-week open-label treatment period, a 16-week washout period, and a 40-week follow-up period.


Eligibility criteria: Inclusion Criteria:

* 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
* 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

Exclusion Criteria:

* 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.
* 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

Primary outcomes:
measure: Number of Participants With at Least One Treatment-Emergent Adverse Event
timeFrame: Up to Week 40
measure: Number of Participants With at Least One Serious Treatment-Emergent Adverse Event
timeFrame: Up to Week 40
measure: Number of Participants With at Least One Protocol-Defined Adverse Event of Special Interest
timeFrame: Up to Week 40
measure: Number of Participants With at Least One Treatment-Related Adverse Event
timeFrame: Up to Week 40
measure: Number of Participants who Discontinued Treatment due to an Adverse Event
timeFrame: Up to Week 40
Secondary outcomes:
measure: Number of Participants With at Least One Protocol-Defined Adverse Event of Special Interest
timeFrame: Week 40 to Week 80
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Teva Investigational Site 12043
state: Arizona
city: Hot Springs
country: United States
facility: Teva Investigational Site 12052
state: Arkansas
city: Fremont
country: United States
facility: Teva Investigational Site 12044
state: California
city: Pasadena
country: United States
facility: Teva Investigational Site 12046
state: California
city: Miramar
country: United States
facility: Teva Investigational Site 12049
state: Florida
city: Chicago
country: United States
facility: Teva Investigational Site 12047
state: Illinois
city: Louisville
country: United States
facility: Teva Investigational Site 12053
state: Kentucky
city: Canton
country: United States
facility: Teva Investigational Site 12048
state: Michigan
city: Portland
country: United States
facility: Teva Investigational Site 12054
state: Oregon
city: Dallas
country: United States
facility: Teva Investigational Site 12045
state: Texas
city: South Jordan
country: United States
facility: Teva Investigational Site 12055
state: Utah
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References: