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

NCT02684097 | Completed Phase 2 Results DMC

• 1 other identifier: GCO 15-1497
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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

Alopecia Areata

Keywords

Alopecia, Alopecia Totalis, Alopecia Universalis

Outcome Measures

Primary Outcomes (1)

• Change in Gene Expression Th2/IL-13, "T22"/IL-22, S100A7 and S100A8, Th1/IFN-gamma, and Th17/IL-17A Jointly Correlated

  Change from baseline in cellular, and molecular markers in skin biopsies after treatment. Gene expression changes in Th2/IL-13, "T22"/IL-22, S100A7 and S100A8, Th1/IFN-gamma, and Th17/IL-17A jointly correlated assessed as change at week 24 compared to baseline of the biomarkers combined z-score expression. Th2/IL-13, T22/IL-22, S100A7 and S100A8, Th1/IFN-gamma, and Th17/IL-17A biomarkers was computed as following. The combined score was obtained by mean z-score expression of all biomarkers, where z-score normalized expression of biomarker X and sample i was obtained by the following formula: \[Xi - mean(Xall\_samples)\]/sd(Xall\_samples). Change in combined z-score for each patient was calculated from two time points as the value at the later time point minus the value at the earlier time point.

  Baseline and Week 24

Secondary Outcomes (4)

• Percentage Change From Baseline in the Severity of Alopecia Tool (SALT)

  Week 24

• Number of Patients Achieving 50% or Greater Improvement in Their SALT Score (SALT50)

  Baseline and Week 24

• Percentage Change From Baseline in the Alopecia Areata Symptom Impact Scale (AASIS)

  Baseline and Week 24

• Percentage Change From Baseline in the Alopecia Areata Quality of Life Questionnaire (AA-QoL)

  Baseline and Week 24

Other Outcomes (1)

• Number of Adverse Events

  Week 40

Study Arms (2)

Tralokinumab

ACTIVE COMPARATOR

Tralokinumab subcutaneous injection every two weeks for 24 weeks

Drug: Tralokinumab

Placebo

PLACEBO COMPARATOR

Saline subcutaneous injection every two weeks for 24 weeks.

Drug: Placebo

Interventions

Tralokinumab DRUG

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

Tralokinumab

Placebo DRUG

Matching placebo given every two weeks for 24 weeks

Also known as: Saline subcutaneous injection

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged from 18 to 75 years, inclusively at the time of signing the informed consent document.
• Subject has provided written informed consent prior to any study specific procedures.
• Body weight of ≥40 and \<150 kg at enrollment.
• Subject has a history of alopecia areata for at least 3 months.
• Subject has extensive patchy alopecia areata (at least 30% scalp hair loss).
• No evidence of hair regrowth at Baseline.
• For WOCBP only: have a negative urine pregnancy test prior to administration of the IP.
• Subject is judged to be in good general health as determined by the principal investigator based upon the results of medical history, laboratory profile, and physical examination performed at Screening.
• Subjects may be naïve to treatment or unresponsive to intralesional steroids or other treatments for alopecia areata.

You may not qualify if:

• History of male or female pattern hair loss Ludwig stage III or Hamilton \> stage V.
• Subjects in whom the diagnosis of alopecia areata is in question.
• Any disorder, including but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could:
• Affect the safety of the subject throughout the study
• Influence the findings of the studies or their interpretations
• Impede the subject's ability to complete the entire duration of study
• Known history of allergy or reaction to any component of the IP formulation.
• History of anaphylaxis following any biologic therapy.
• The following treatments within 4 weeks before the Baseline visit, or any condition that, in the opinion of the investigator, will likely require such treatment(s) at any time during the study:
• Systemic corticosteroids
• Immunosuppressive/immunomodulating drugs (eg, cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase (JAK) inhibitors, azathioprine or methotrexate), Ultra-Violet (UV) B phototherapy; and/or Psoralen Ultra-Violet A (PUVA) therapy.
• Treatment with topical corticosteroids, tacrolimus and/or pimecrolimus within 1 week before the Baseline visit.
• Subject has taken enzyme-modifying drugs that are moderate inhibitors/potent inducers of cytochrome P450 3A4 or potent inhibitors of cytochrome P450 2C19 enzymes (such as cimetidine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole etc…) and strong inducers of CYP enzymes (such as rifampin etc…), in the previous 28 days before day 0.
• A helminth parasitic infection diagnosed within 6 months prior to the date informed consent or assent obtained that has not been treated with, or has failed to respond to, standard of care therapy.
• History of clinically significant infection, including acute upper or lower respiratory infections, requiring antibiotics or antiviral medication within 30 days prior to the date informed consent or assent is obtained or during the run-in period.

Sponsors & Collaborators

• Emma Guttman: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (5)

• Alkhalifah A. Alopecia areata update. Dermatol Clin. 2013 Jan;31(1):93-108. doi: 10.1016/j.det.2012.08.010. Epub 2012 Oct 2.

  PMID: 23159179 BACKGROUND

• Safavi KH, Muller SA, Suman VJ, Moshell AN, Melton LJ 3rd. Incidence of alopecia areata in Olmsted County, Minnesota, 1975 through 1989. Mayo Clin Proc. 1995 Jul;70(7):628-33. doi: 10.4065/70.7.628.

  PMID: 7791384 BACKGROUND

• Huang KP, Mullangi S, Guo Y, Qureshi AA. Autoimmune, atopic, and mental health comorbid conditions associated with alopecia areata in the United States. JAMA Dermatol. 2013 Jul;149(7):789-94. doi: 10.1001/jamadermatol.2013.3049.

  PMID: 23700152 BACKGROUND

• Betz RC, Pforr J, Flaquer A, Redler S, Hanneken S, Eigelshoven S, Kortum AK, Tuting T, Lambert J, De Weert J, Hillmer AM, Schmael C, Wienker TF, Kruse R, Lutz G, Blaumeiser B, Nothen MM. Loss-of-function mutations in the filaggrin gene and alopecia areata: strong risk factor for a severe course of disease in patients comorbid for atopic disease. J Invest Dermatol. 2007 Nov;127(11):2539-43. doi: 10.1038/sj.jid.5700915. Epub 2007 Jun 21.

  PMID: 17581619 BACKGROUND

• Olsen EA, Hordinsky MK, Price VH, Roberts JL, Shapiro J, Canfield D, Duvic M, King LE Jr, McMichael AJ, Randall VA, Turner ML, Sperling L, Whiting DA, Norris D; National Alopecia Areata Foundation. Alopecia areata investigational assessment guidelines--Part II. National Alopecia Areata Foundation. J Am Acad Dermatol. 2004 Sep;51(3):440-7. doi: 10.1016/j.jaad.2003.09.032. No abstract available.

  PMID: 15337988 BACKGROUND

MeSH Terms

Conditions

Alopecia Areata; Alopecia; Alopecia universalis

Interventions

tralokinumab

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Emma Guttman
• Organization: Icahn School of Medicine at Mount Sinai

emma.guttman@mountsinai.org

212-241-9728

Study Officials

• Emma Guttman, MD, PhD

  ISMMS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 11, 2016
• First Posted: February 17, 2016
• Study Start: January 1, 2016
• Primary Completion: November 28, 2017
• Study Completion: November 28, 2017
• Last Updated: January 7, 2020
• Results First Posted: January 7, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)