Test of ACT-777991 in adults with non-segmental vitiligo

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 trial will assess the safety, tolerability, and skin-color outcomes of ACT-777991 in adults with non-segmental vitiligo. Participants are randomized 2:1 to receive either ACT-777991 or a placebo daily for 24 weeks, with visits for exams and tests. After treatment, participants are followed for about one month to monitor any lasting effects or adverse events.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Clinical diagnosis of either active or stable non segmental vitiligo for at least 3 months prior to Screening and meet all the following criteria:

  * F-VASI score ≥ 0.3 based on BICR at Screening.
  * T-VASI score ≥ 5 based on investigator assessment at Screening and Randomization.
  * Total body surface area (BSA) involvement, including the face, ≤ 50% based on investigator assessment at Screening and Randomization.
* Participants must agree not to use therapeutic agents and procedures to treat vitiligo from Screening until Participant Last Visit.

Applicable only to EU: In addition to the above, participants must not have discontinued, reduced, or modified a vitiligo treatment/ procedure for the purpose of meeting trial eligibility criteria or a wash out requirement.

Exclusion Criteria:

* Clinical diagnosis of other forms of vitiligo (e.g., segmental) or other hypo- or depigmentation disorders (e.g., piebaldism, leukoderma, Vogt-Koyanagi-Harada disease, malignancy-induced hypopigmentation).
* Any autoimmune disease, except adequately treated thyroid disease.
* History of systemic immunotherapy treatment, including JAK inhibitors, for any inflammatory disease in the 12 months prior to Randomization.
* History of topical JAK inhibitors for any inflammatory disease in the 6 weeks prior to Screening.
* Use of laser or light-based treatment (phototherapy), including tanning beds, in the 8 weeks prior to Screening.
* eGFR \< 90 mL/min/1.73 m\^2, defined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation, at Screening.

Where it's running

• Vitiligo & Pigmentation Institute of Southern California
  Los Angeles, California, United States Recruiting
• Centrum Medyczne Angelius Provita
  Katowice, Poland Not yet recruiting
• Medistica s.c.
  Krakow, Poland Not yet recruiting
• Małopolskie Centrum Kliniczne
  Krakow, Poland Not yet recruiting
• DermoDent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski s.c.
  Osielsko, Poland Not yet recruiting

Study contacts

• Study coordinator: Clinical Trial Information USA
• Email: idorsiaclinicaltrials@idorsia.com
• Phone: +1 856 661 37 21

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• ICP-332 treatment for non-segmental vitiligo

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.