TEV-53408 for Vitiligo

Recruiting at 11 trial locations

Overseen By Teva U.S. Medical Information

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Disqualifiers: Autoimmune diseases, Malignancy, Infectious disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety of a new treatment called TEV-53408 for individuals with vitiligo, a condition that causes patches of skin to lose color. Participants will receive the treatment through an injection under the skin. Those who have had vitiligo for at least three months and meet specific criteria, such as not having recent cancer treatment or other autoimmune diseases, might be suitable candidates. Participants should also be willing to stop other vitiligo treatments during the trial and avoid unprotected sun exposure.

As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires participants to stop all treatments specifically for vitiligo during the treatment period. However, if you are taking medications for other conditions, you can continue them as long as your regimen is stable.

Is there any evidence suggesting that TEV-53408 is likely to be safe for humans?

Research shows that TEV-53408 is still undergoing testing to ensure its safety for people with vitiligo. Specific information on how well participants tolerate it is not yet available, as it remains in the early testing stages. TEV-53408 is currently in Phase 1 trials, where it is being tested for safety in humans for the first time. This phase typically involves only a small group of participants. Potential side effects are not well-known at this stage. The primary goal is to determine if the drug is safe when administered as an injection under the skin. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for vitiligo?

TEV-53408 is unique because it's administered subcutaneously, which could offer a more direct and potentially faster-acting approach compared to topical creams or light therapy, which are commonly used for vitiligo. Researchers are excited about TEV-53408 because it may target the condition differently, possibly providing a new way to manage or reverse the loss of skin pigmentation. This method of delivery might also enhance patient compliance and convenience, making it a promising option for those who struggle with more traditional treatments.

What evidence suggests that TEV-53408 might be an effective treatment for vitiligo?

Researchers are investigating TEV-53408 as a potential treatment for vitiligo, a condition where patches of skin lose color. Participants in this trial will receive TEV-53408 subcutaneously. While specific human data for vitiligo is limited, TEV-53408 is also under study for celiac disease, suggesting it might influence the immune system. This is significant because vitiligo may involve the immune system attacking skin cells. These early studies aim to determine if TEV-53408 can assist with conditions related to immune system activity. However, clear results on its effectiveness for vitiligo are still forthcoming. ^{1 2 3 4 5}

Who Is on the Research Team?

Teva Medical Expert, MD

Principal Investigator

Teva Branded Pharmaceutical Products R&D, Inc.

Are You a Good Fit for This Trial?

This trial is for adults with vitiligo, a skin condition causing loss of pigment. Participants must have had vitiligo for at least 3 months, have a BMI between 18.5 and 40.0 kg/m2, agree to use effective contraception if necessary, not be pregnant or breastfeeding, and avoid sun exposure during the trial.

Inclusion Criteria

I have been diagnosed with vitiligo for at least 3 months.

I am not pregnant or breastfeeding, can't have children or use effective birth control, and won't donate eggs.

I agree to not donate sperm and either abstain from sex or use a condom.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

up to 4 weeks

Treatment

Participants receive TEV-53408 administered subcutaneously in an open-label manner

24 weeks

Washout

Participants undergo a washout period to clear the drug from their system

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

40 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TEV-53408

Trial Overview The study tests TEV-53408's safety and effectiveness in treating vitiligo over an 84-week period involving treatment, washout, and follow-up phases. The drug is given as a subcutaneous injection.

How Is the Trial Designed?

Group I: TEV-53408 Experimental Treatment 1 Intervention

solution administered subcutaneously

Who Is Running the Clinical Trial?

Teva Branded Pharmaceutical Products R&D, Inc.

Lead Sponsor

Trials

258

Recruited

3,487,000+

Dr. Eric Hughes

Teva Branded Pharmaceutical Products R&D, Inc.

Chief Medical Officer since 2022

MD and PhD from Yale School of Medicine

Richard Francis

Teva Branded Pharmaceutical Products R&D, Inc.

Chief Executive Officer since 2022

Bachelor's degree in Biochemistry from the University of Manchester

Teva Branded Pharmaceutical Products R&D LLC

Lead Sponsor

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06625177

A Trial to Test the Safety and Efficacy of TEV-53408 in ... A Phase 1b, Open-Label Trial to Assess Safety and Exploratory Efficacy of TEV-53408 in Participants With Vitiligo. Conditions. Vitiligo. Vitiligo. Vitiligo.

2. tevapharm.com tevapharm.com/teva-clinical-trials/clinical-trials-results/clinical-trials/tv53408imm10209

A Trial to Test the Safety and Efficacy of TEV-53408 in ... Primary objectives: The primary objective of the trial is to evaluate the safety of TEV-53408 administered subcutaneously for the treatment of adults with ...

3. clinicaltrials.eu clinicaltrials.eu/inn/tev-53408/

TEV-53408: A Promising Treatment for Vitiligo and Celiac ... This trial is assessing both safety and efficacy, with a focus on whether TEV-53408 can protect the small intestine from damage when participants with celiac ...

4. synapse.patsnap.com synapse.patsnap.com/drug/6b631175e5c94136bfa4b66e8c1c0b3b

TEV-53408 - Drug Targets, Indications, Patents A multicenter, randomized, double-blind, placebo-controlled, Phase 2a trial to characterize the efficacy and safety of TEV-53408 in adults with celiac disease.

5. vrfoundation.org vrfoundation.org/trials/a-trial-to-test-the-safety-and-efficacy-of-tev-53408-in-treating-vitiligo

A Trial to Test the Safety and Efficacy of TEV-53408 in ... The Phase 2 trial, sponsored by Teva Branded Pharmaceutical Products, aims to evaluate the safety of subcutaneously administered TEV-53408 in adults with ...