Teva to launch Phase 2b trial of TEV‑’408 in vitiligo after positive Phase 1b results, advancing its IL‑15 immunology program with Royalty Pharma support.
Written By: Fariha Sameen, PharmD
Reviewed By: Pharmacally Editorial Team
Teva Pharmaceutical Industries will initiate a Phase 2b clinical trial of TEV-‘408 in adults with non-segmental vitiligo (NSV) during the fourth quarter of 2026 after positive findings from an ongoing Phase 1b study. The investigational anti-interleukin-15 (IL-15) monoclonal antibody improved skin pigmentation in patients with active or stable disease while demonstrating a favorable safety profile, with no treatment-related safety signals observed to date.
The decision advances one of Teva’s internally discovered immunology programs and strengthens its pipeline in autoimmune diseases, where treatment options remain limited, particularly for patients with extensive skin involvement requiring systemic therapy.
Targeting IL-15 to interrupt the autoimmune process in vitiligo
Vitiligo is a chronic autoimmune disorder in which immune cells destroy melanocytes, leading to progressive loss of skin pigmentation. IL-15 plays a central role in sustaining tissue-resident memory T cells that drive ongoing melanocyte destruction, making the pathway an attractive therapeutic target.
TEV-‘408 is a human monoclonal antibody that blocks IL-15 activity. The therapy has demonstrated high affinity and prolonged half-life in preclinical studies and is being developed as a subcutaneous injection administered once every 12 weeks, offering a potentially convenient quarterly dosing schedule.
Beyond vitiligo, the antibody is also under evaluation in a Phase 2a trial for celiac disease and received U.S. FDA Fast Track designation for that indication in May 2025.
Phase 1b study demonstrated meaningful facial repigmentation with favorable tolerability
The ongoing open-label Phase 1b trial (NCT06625177) enrolled adults with active or stable NSV who had facial or total body vitiligo above predefined disease severity thresholds. Participants received two subcutaneous doses of TEV-‘408, administered at baseline and again at Week 12. The primary efficacy assessment was the Vitiligo Area Scoring Index (VASI) at Week 24, while patients continue to be monitored through Week 80.
Approximately two-thirds of enrolled participants had vitiligo affecting more than 10% of body surface area, representing patients with substantial unmet treatment needs.
Among evaluable patients at Week 24:
- Nearly 75% reported improvement in facial vitiligo, with half describing their improvement as “much” or “very much” improved.
- 42% achieved F-VASI50, indicating at least a 50% improvement in facial vitiligo severity.
- 21% achieved F-VASI75, reflecting at least 75% facial repigmentation.
- 55% reported improvement in total body vitiligo.
- 7% achieved T-VASI50, representing at least a 50% improvement in total body disease.
Across the study, TEV-‘408 was well tolerated, and investigators reported no safety signals.
Company sees IL-15 program as a key immunology growth driver
Teva President and CEO Richard Francis said TEV-‘408 reflects the company’s strategy of advancing internally discovered therapies that address significant unmet medical needs through differentiated immunology programs.
Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer, said the early findings reinforce confidence in IL-15 as a therapeutic target and support continued development of the antibody as a potential systemic treatment for people living with vitiligo.
Phase 2b study planned for late 2026
Teva plans to launch the Phase 2b vitiligo study in the fourth quarter of 2026 to further evaluate the efficacy and safety of TEV-‘408 in a larger patient population. The program is supported by a strategic agreement with Royalty Pharma, which provides up to $500 million in research and development funding to accelerate clinical development, including the planned Phase 2b trial.
If later-stage studies confirm these early results, TEV-‘408 could offer a new systemic treatment approach for patients with moderate-to-severe vitiligo by targeting a central immune pathway responsible for ongoing melanocyte destruction while providing the convenience of quarterly subcutaneous dosing.
What This Means for Patients
For people living with vitiligo, especially those with more extensive disease, these early results offer cautious optimism. Many participants experienced noticeable improvements in skin repigmentation, particularly on the face, and the treatment was generally well tolerated without new safety concerns reported so far.
TEV-‘408 is still an investigational medicine and is not yet available outside clinical trials. Teva plans to begin a larger Phase 2b study later in 2026 to confirm these findings in more patients. If future studies continue to show positive results, TEV-‘408 could become a new treatment option for people seeking better control of vitiligo and longer-lasting improvement in skin pigmentation.
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About the Writer
Fariha Sameen, PharmD (LinkedIn), is a clinical pharmacy professional with hands-on experience in patient counselling, medication review, therapeutic monitoring, and clinical documentation across multiple departments. She has experience identifying and assessing drug-related problems and supporting medication safety practices. Her interests include pharmacovigilance, ADR reporting, clinical research, and medical writing focused on clear, evidence-based communication.