A Study of ATI-50002 Topical Solution for the Treatment of Vitiligo

NCT03468855 | Completed Phase 2 Results FDA Drug

• 1 other identifier: ATI-50002-VITI-201
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 5

Brief Summary

The main objective of this study is to assess the safety, tolerability and efficacy of ATI-50002 Topical Solution, 0.46% in subjects with non-segmental facial vitiligo.

Conditions

Vitiligo

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline to Week 24

  Mean change from baseline in facial depigmentation in quantified Area of Interest (AOI) using Canfield-2-D photographic image analysis from baseline (Visit 2) compared to Week 24. Facial depigmentation is measured on a scale of 0 to 100, with a score of 0 meaning no depigmentation and a score of 100 meaning total depigmentation. Lower scores represent better outcomes.

  Baseline to 24 Weeks

Secondary Outcomes (30)

• Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Week 48

  Baseline to 48 Weeks

• Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Week 4

  Baseline to 4 Weeks

• Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Week 8

  Baseline to 8 Weeks

• Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Week 12

  Baseline to 12 Weeks

• Mean Change From Baseline in Facial Depigmentation in the AOI (Area of Interest) Based on Canfield 2-D Photographic Analysis From Baseline Compared to Week 16

  Baseline to 16 Weeks

Study Arms (1)

ATI-50002 Topical Solution

EXPERIMENTAL

ATI-50002 topical solution, high dose active, twice-daily, 24 weeks

Drug: ATI-50002 topical solution

Interventions

ATI-50002 topical solution DRUG

Topical Solution administered twice daily

ATI-50002 Topical Solution

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has a clinical diagnosis of new onset or actively progressing non-segmental facial vitiligo or worsening of existing facial lesions within the past 6 months.
• Subject has non-segmental facial vitiligo effecting at least 0.25% total body surface area (TBSA) (excluding the upper and lower eyelids, mucosal lip areas and forehead and chin areas covered by the stereotactic positioning device for photography) with at least one area of the face with normal pigmentation.
• Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at the baseline visit and must agree to use an approved method of highly effective birth control for the duration of the study and for 30 days after last study medication application.
• Subject is in good general health and free of any known disease state or physical condition which, in the opinion of the investigator, would interfere with the study assessments or put the subject at undue risk by study participation.
• Subject agrees to refrain from any other treatments for vitiligo from the screening visit through the final follow-up visit. Over the counter (OTC) preparations deemed acceptable by the investigator and camouflage makeups are permitted.

You may not qualify if:

• Subject with evidence of poliosis (white hairs) in \> 50% of their facial vitiligo lesions.
• Subject with total facial depigmentation.
• Subject with spontaneous ongoing repigmentation (documented based on the subject's reporting in the last 3 months).
• Subject who has segmental vitiligo.
• Subject who has failed phototherapy. Failed phototherapy is defined as failure to achieve satisfactory repigmentation following adequately delivered phototherapy as determined by the investigator.
• Subject currently has, or has a history of, skin disease (e.g., psoriasis, seborrheic dermatitis, etc.) that, in the opinion of the investigator, would interfere with the study medication application or study assessments.
• Subject has, or has a history of, severe, progressive or uncontrolled autoimmune, metabolic, renal, hepatic, gastrointestinal, pulmonary, cardiovascular, genitourinary (i.e.,renal disease), hematological disease, neurologic or cerebral disorders, infectious disease or coagulation disorders that, in the opinion of the investigator, would interfere with the study assessments or put the subject at undue risk by study participation.
• Subject currently has a history of, current, or suspected systemic or cutaneous malignancy and/or lymphoproliferative disease, other than a history of adequately treated, well healed and completely cleared non-melanoma skin cancers (e.g., basal or squamous cell carcinoma) treated successfully at least 1 year prior to study entry with no evidence of disease.
• Subject currently has evidence of active or latent bacterial (including tuberculosis) or viral infections at the time of enrollment, or a history of incompletely treated or untreated tuberculosis. Subjects who have initiated therapy for latent tuberculosis for at least 2 weeks and agree to continue their therapy through completion may participate.
• Subject has a history of serious local infection (e.g., cellulitis, abscess) or systemic infection, or history of treated infection (e.g., pneumonia, septicemia) within 3 months prior to the baseline visit. Subjects on an antibiotic for a nonserious, acute local infection must complete the course prior to enrollment into the study.
• Subject has herpes zoster or cytomegalovirus (CMV) that resolved within 8 weeks prior to Visit 1.
• Subject has a history of frequent outbreaks of oral Herpes Simplex Virus defined as more than 4 episodes per year.
• Subjects previously treated with depigmenting agents.
• Clinically significant laboratory abnormalities at screening that in the opinion of the investigator, would make the subject a poor candidate for the study.
• Subject who has an absolute neutrophil count \<1,000/mm3, or platelet count \< 50,000/mL.

Sponsors & Collaborators

• Aclaris Therapeutics, Inc.: lead

Study Sites (5)

Aclaris Investigator Site

Encinitas, California, 92024, United States

Location

Aclaris Investigator Site

Los Angeles, California, 90036, United States

Location

Aclaris Investigator Site

Worcester, Massachusetts, 01655, United States

Location

Aclaris Investigator Site

Dallas, Texas, 75390, United States

Location

Aclaris Investigator Site

Lynchburg, Virginia, 24501, United States

Location

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: David Gordon
• Organization: Aclaris Therapeutics, Inc.

Clintrials@aclaristx.com

484-540-6296

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2018
• First Posted: March 19, 2018
• Study Start: March 19, 2018
• Primary Completion: October 16, 2019
• Study Completion: October 16, 2019
• Last Updated: November 30, 2020
• Results First Posted: November 30, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)