A Study to Assess the Safety and Efficacy of ZPL389 in Patients With Moderate to Severe Atopic Dermatitis

NCT03517566 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: CZPL389A2203
• Study Type: interventional
• Target: 293
• Locations: 16 countries
• Sites: 89

Brief Summary

This was a randomized, double-blind, placebo-controlled, parallel-group study to assess safety and efficacy of ZPL389 in subjects with moderate to severe atopic dermatitis with a total study duration up to 24 weeks

Conditions

Atopic Dermatitis

Keywords

atopic dermatitis; AD; eczema; atopic eczema; itch, pruritus; histamine 4 receptor; antagonist; H4R; ZPL389; ZPL389A2203; dermatitis

Outcome Measures

Primary Outcomes (1)

• Percentage of IGA Responders at Week 16

  Investigator's Global Assessment (IGA) score is used to determine the severity of atopic dermatitis symptoms and clinical response to treatment. It reflects a subject's overall disease severity for the whole body. The scale includes 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. It is a static scale and does not refer to previous status of the subject. IGA response is defined as achievement of an IGA score of 0 or 1 with a 2-point reduction from baseline without use of confounding therapy (e.g. rescue medication) up to the assessment time point. Treatment discontinuations for lack of efficacy or adverse event are considered non-responders. Percentage of responders was calculated based on a logistic regression model with response as outcome variable and treatment (dose as categorical variable) and baseline IGA as covariates.

  Week 16

Secondary Outcomes (6)

• Percent Change From Baseline in EASI Score at Week 16

  Baseline, Week 16

• Percent Change From Baseline in EASI Score Over Time

  Baseline, Week 2, Week 4, Week 6, Week 8, Week 12

• Percentage of EASI50 Responders Over Time

  Week 2, Week 4, Week 6, Week 8, Week 12, Week 16

• Percentage of EASI75 Responders Over Time

  Week 2, Week 4, Week 6, Week 8, Week 12, Week 16

• Percentage of IGA Responders Over Time

  Week 2, Week 4, Week 6, Week 8, Week 12

Study Arms (5)

placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

ZPL389 3mg

EXPERIMENTAL

ZPL389 3 mg oral powder

Drug: ZPL389 3mg

ZPL389 10 mg

EXPERIMENTAL

ZPL389 10 mg oral powder

Drug: ZPL389 10mg

ZPL389 30mg

EXPERIMENTAL

ZPL389 30 mg oral powder

Drug: ZPL389 30mg

ZPL389 50mg

EXPERIMENTAL

ZPL389 50 mg oral powder

Drug: ZPL389 50mg

Interventions

Placebo DRUG

once daily from baseline until week 16

placebo

ZPL389 3mg DRUG

ZPL389 3 mg oral powder; once daily from baseline to week 16

ZPL389 3mg

ZPL389 10mg DRUG

ZPL389 10 mg oral powder; once daily from baseline to week 16

ZPL389 10 mg

ZPL389 30mg DRUG

ZPL389 30 mg oral powder; once daily from baseline to week 16

ZPL389 30mg

ZPL389 50mg DRUG

ZPL389 50 mg oral powder; once daily from baseline to week 16

ZPL389 50mg

Eligibility Criteria

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

You may qualify if:

• Subjects must give a written, signed and dated informed consent
• Chronic atopic dermatitis present for at least 1 year before Baseline
• Moderate to severe atopic dermatitis defined as per EASI, IGA and BSA.
• Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable
• Candidate for systemic treatment

You may not qualify if:

• Any skin disease that would confound the diagnosis or evaluation of atopic dermatitis disease activity
• Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days or until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
• History of hypersensitivity to any of the study drug constituents or to drugs of similar chemical classes.
• Participation in prior ZPL389 studies

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (89)

Novartis Investigative Site

Litchfield Park, Arizona, 85340, United States

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Novartis Investigative Site

Fountain Valley, California, 92708, United States

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Novartis Investigative Site

San Diego, California, 92103, United States

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Novartis Investigative Site

San Diego, California, 92123, United States

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Novartis Investigative Site

Tampa, Florida, 33609, United States

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Novartis Investigative Site

Tampa, Florida, 33612, United States

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Novartis Investigative Site

Louisville, Kentucky, 40217, United States

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Novartis Investigative Site

Cincinnati, Ohio, 45231, United States

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Novartis Investigative Site

Fairborn, Ohio, 45324, United States

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Novartis Investigative Site

Greer, South Carolina, 29651, United States

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Novartis Investigative Site

Houston, Texas, 77004, United States

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Novartis Investigative Site

West Jordan, Utah, 84088, United States

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Novartis Investigative Site

Vienna, A 1090, Austria

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Novartis Investigative Site

Leuven, 3000, Belgium

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Novartis Investigative Site

Markham, Ontario, L3P 1A8, Canada

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Novartis Investigative Site

Newmarket, Ontario, L3Y 5G8, Canada

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Novartis Investigative Site

Toronto, Ontario, M4V 1R2, Canada

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Novartis Investigative Site

Waterloo, Ontario, N2J 1C4, Canada

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Novartis Investigative Site

Sainte-Hyacinthe, Quebec, J2S 66, Canada

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Novartis Investigative Site

Karlovy Vary, Czech Republic, 36001, Czechia

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Novartis Investigative Site

Nový Jičín, Czech Republic, 74101, Czechia

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Novartis Investigative Site

Prague, Prague 1, 11000, Czechia

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Novartis Investigative Site

Prague, 100 00, Czechia

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Novartis Investigative Site

Helsinki, 00250, Finland

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Novartis Investigative Site

Tampere, 33520, Finland

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Novartis Investigative Site

Turku, 20520, Finland

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Novartis Investigative Site

Bielefeld, 33647, Germany

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Novartis Investigative Site

Braunschweig, 38100, Germany

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Novartis Investigative Site

Frankfurt, 60590, Germany

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Novartis Investigative Site

Gera, 07548, Germany

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Novartis Investigative Site

Halle, 06108, Germany

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Novartis Investigative Site

Hamburg, 20537, Germany

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Novartis Investigative Site

Hamburg, 22391, Germany

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Novartis Investigative Site

Hanover, 30625, Germany

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Novartis Investigative Site

Heidelberg, 69120, Germany

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Novartis Investigative Site

Memmingen, 87700, Germany

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Novartis Investigative Site

München, 80337, Germany

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Novartis Investigative Site

Münster, 48149, Germany

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Novartis Investigative Site

Osnabrück, 49074, Germany

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Novartis Investigative Site

Debrecen, 4032, Hungary

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Novartis Investigative Site

Kopavogur, 201, Iceland

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Novartis Investigative Site

Nagoya, Aichi-ken, 467-8602, Japan

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Novartis Investigative Site

Sapporo, Hokkaido, 060-0063, Japan

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Novartis Investigative Site

Kobe, Hyōgo, 654 0011, Japan

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Novartis Investigative Site

Yokohama, Kanagawa, 220-6208, Japan

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Novartis Investigative Site

Yokohama, Kanagawa, 221-0825, Japan

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Novartis Investigative Site

Sakai, Osaka, 593-8324, Japan

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Novartis Investigative Site

Shinagawa Ku, Tokyo, 141 8625, Japan

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Novartis Investigative Site

Shinjuku Ku, Tokyo, 162 8655, Japan

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Novartis Investigative Site

Shinjuku-ku, Tokyo, 160-0023, Japan

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Novartis Investigative Site

Fukuoka, 819 0167, Japan

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Novartis Investigative Site

Fukuoka, 819-0373, Japan

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Novartis Investigative Site

Kyoto, 606 8507, Japan

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Novartis Investigative Site

Tokyo, 158 0097, Japan

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Novartis Investigative Site

Bergen op Zoom, 4624 VT, Netherlands

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Novartis Investigative Site

Breda, 4818 CK, Netherlands

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Novartis Investigative Site

Groningen, 9713 GZ, Netherlands

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Novartis Investigative Site

Rotterdam, 3015 CE, Netherlands

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Novartis Investigative Site

Warsaw, Mazowian, 02 495, Poland

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Novartis Investigative Site

Katowice, 40-648, Poland

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Novartis Investigative Site

Rzeszów, 35 055, Poland

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Novartis Investigative Site

Warsaw, 04141, Poland

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Novartis Investigative Site

Chelyabinsk, 454092, Russia

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Novartis Investigative Site

Kazan', 420012, Russia

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Novartis Investigative Site

Krasnodar, 350020, Russia

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Novartis Investigative Site

Moscow, 123182, Russia

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Novartis Investigative Site

Petrozavodsk, 185019, Russia

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Novartis Investigative Site

Saint Petersburg, 191123, Russia

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Novartis Investigative Site

Saint Petersburg, 192007, Russia

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Novartis Investigative Site

Saint Petersburg, 194223, Russia

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Novartis Investigative Site

Saint Petersburg, 194325, Russia

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Novartis Investigative Site

Saint Petersburg, 196143, Russia

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Novartis Investigative Site

Saint Petersburg, 196240, Russia

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Novartis Investigative Site

Saint Petersburg, 197136, Russia

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Novartis Investigative Site

Smolensk, 214019, Russia

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Novartis Investigative Site

Stavropol, 355020, Russia

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Novartis Investigative Site

Yekaterinburg, 620023, Russia

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Novartis Investigative Site

Yekaterinburg, 620109, Russia

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Novartis Investigative Site

Bardejov, SVK, 085 01, Slovakia

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Novartis Investigative Site

Bratislava, 85101, Slovakia

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Novartis Investigative Site

Levice, 934 01, Slovakia

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Novartis Investigative Site

Svidník, 08901, Slovakia

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Novartis Investigative Site

Taichung, Taiwan ROC, 40201, Taiwan

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Novartis Investigative Site

Taipei, 10002, Taiwan

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Novartis Investigative Site

Plymouth, Devon, PL6 8DH, United Kingdom

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Novartis Investigative Site

Dudley, West Midlands, DY1 2HQ, United Kingdom

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Novartis Investigative Site

Liverpool, L14 3PE, United Kingdom

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Novartis Investigative Site

London, SE1 9RT, United Kingdom

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Novartis Investigative Site

Portsmouth, PO3 6AD, United Kingdom

Location

Related Links

• A Plain Language Trial Summary is available on novartisclinicaltrials.com

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema; Pruritus; Dermatitis

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: 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: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2018
• First Posted: May 7, 2018
• Study Start: November 14, 2018
• Primary Completion: July 15, 2020
• Study Completion: August 6, 2020
• Last Updated: October 8, 2021
• Results First Posted: July 20, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share

Locations

BE (1); AU (1); DE (13); NL (4); IC (1); FI (3); US (12); CA (5); GB (5); CZ (4); TW (2); RU (16); HU (1); PL (4); SL (4); JP (13)