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A Pilot Study of Tralokinumab in Subjects With Moderate to Severe Alopecia Areata

NCT02684097 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2020-01-07

Study results available
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Summary

The purpose of this study is to assess whether tralokinumab can be a helpful treatment for alopecia areata. This is a randomized, double-blind, placebo-controlled pilot study of a total of 30 subjects with moderate to severe alopecia areata involving 30-100% of the scalp. Expected is 50% of these subjects to have concomitant alopecia areata (AA) and atopic dermatitis (AD). Subjects with AA alone (15 subjects) will be randomized (2:1) to either receive tralokinumab or placebo via subcutaneous injection every 2 weeks for 24 weeks. Subjects with concomitant alopecia areata and atopic dermatitis (15 subjects) will be randomized separately in a 2:1 ratio to receive tralokinumab or placebo via subcutaneous injection every 2 weeks for 24 weeks.

Conditions

Interventions

DRUG

Tralokinumab

All groups will receive study drug every two weeks for 24 weeks.

DRUG

Placebo

Matching placebo given every two weeks for 24 weeks

Sponsors & Collaborators

  • Emma Guttman

    lead OTHER

Principal Investigators

  • Emma Guttman, MD, PhD · ISMMS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2017-11-28
Completion
2017-11-28

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02684097 on ClinicalTrials.gov