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Clinical Trial Details for An Open-Label, Single-Arm Study to Assess the Safety and Efficacy of Lebrikizumab in Adolescent Patients With Moderate-to-Severe Atopic Dermatitis


Dermira, Inc.
NCT ID: NCT04250350
Last Updated: January 30, 2020

The Study at a Glance

  • Status: Not yet recruiting
  • Phase: Phase 3
  • Gender: All
  • Age: 12 Years - N/A
  • Condition: Atopic Dermatitis
  • Study Type: Interventional
  • Intervention:
  • Lead Sponsor: Dermira, Inc.
  • Location: Not Provided

Official Title

An Open-Label, Single-Arm Study to Assess the Safety and Efficacy of Lebrikizumab in Adolescent Patients With Moderate-to-Severe Atopic Dermatitis

Purpose

This is an open-label, single arm study of 52 weeks duration. The study will assess the safety and efficacy of lebrikizumab in adolescent patients age 12 years and above, weighing at least 40 kg, with moderate to severe atopic dermatitis.

Eligibility

Ages Eligible for Study

12 Years to N/A

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Criteria

Inclusion Criteria:

1. Male or female adolescent (≥12 years to 17 years, and weighing ≥40 kg).

2. Chronic AD (according to American Academy of Dermatology Consensus Criteria) that has
been present for ≥1 year before the screening visit.

3. Eczema Area and Severity Index (EASI) score ≥16 at the baseline visit.

4. Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the baseline visit

5. ≥10% body surface area (BSA) of AD involvement at the baseline visit.

6. History of inadequate response to treatment with topical medications; or determination
that topical treatments are otherwise medically inadvisable.

Exclusion Criteria:

1. Participation in a prior lebrikizumab clinical study.

2. Treatment with the following prior to the baseline visit:

1. An investigational drug within 8 weeks or within 5 half-lives (if known),
whichever is longer.

2. Dupilumab within 8 weeks.

3. Cell-depleting biologics, including to rituximab, within 6 months.

4. Other biologics within 5 half-lives (if known) or 16 weeks, whichever is longer.

3. Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or
planned during the study.

4. Uncontrolled chronic disease that might require bursts of oral corticosteroids.

5. Evidence of active acute or chronic hepatitis

6. History of human immunodeficiency virus (HIV) infection or positive HIV serology at
screening.

7. History of malignancy, including mycosis fungoides, within 5 years before the
screening visit, except completely treated in situ carcinoma of the cervix, completely
treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.

8. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed
during the study.

Additional Information, Locations & Contacts

Sponsors & Collaborators

Dermira, Inc.

Investigators

Study Director: Kate Doherty

Dermira, Inc.

Please refer to this study by its ClinicalTrials.gov identifier: NCT04250350

Location

Contacts

Site 1711

Fountain Valley, California 92708

United States

First OC Dermatology

Site 1709

Albany, Georgia 31707

United States

Georgia Pollens Clinical Research Centers Inc.

Site 1710

Louisville, Kentucky 40217

United States

Skin Sciences, PLLC

Site 1703

Portsmouth, New Hampshire 03801

United States

ActivMed Practices and Research Inc.

Site 1713

Forest Hills, New York 11375

United States

Forest Hills Dermatology Group

Site 1701

Watertown, New York 13601

United States

Advanced Asthma and Allergy

Site 1702

San Antonio, Texas 78213

United States

Progressive Clinical Research P.A.

Site 1706

Kraków, Malopolskie 30-033

Poland

Grażyna Pulka Centrum Medyczne All-med

Site 1707

Kraków, Małopolskie 31-559

Poland

Diamond Clinic

Site 1712

Kielce, Swietokrzyskie 25-155

Poland

Gabinet Dermatlogiczny. Beata Krecisz

Site 1705

Iwonicz-Zdrój, Województwo Podkarpackie 38-440

Poland

Zespol Naukowo - Leczniczy Iwolang Sp. z o.o.

Site 1708

Katowice, 40-611

Poland

Provita Sp. z o.o.