A Trial to Test the Safety and Efficacy of TEV-53408 in Participants With Vitiligo
ConditionVitiligo
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTeva Branded Pharmaceutical Products R&D LLC
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
TEV-53408
DrugTEV-53408 injection administered subcutaneously
Treatment groups
66 Participants
are divided into 3 treatment groupsGroup A: Cohort 1Experimental treatment 1 intervention
Group B: Cohort 2Experimental treatment 1 intervention
Group C: Cohort 3Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants With at Least One Treatment-Emergent Adverse Event
Time frame
Up to Week 402
Number of Participants With at Least One Serious Treatment-Emergent Adverse Event
Time frame
Up to Week 403
Number of Participants With at Least One Protocol-Defined Adverse Event of Special Interest
Time frame
Up to Week 404
Number of Participants With at Least One Treatment-Related Adverse Event
Time frame
Up to Week 40Secondary outcomes
1
Number of Participants With at Least One Protocol-Defined Adverse Event of Special Interest
Time frame
Week 40 to Week 80Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov