A Study to Assess the Safety and Efficacy of ZPL389 in Patients With Moderate to Severe Atopic Dermatitis
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| ClinicalTrials.gov Identifier: NCT03517566 |
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Recruitment Status :
Terminated
(Lack of efficacy)
First Posted : May 7, 2018
Results First Posted : July 20, 2021
Last Update Posted : October 8, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Atopic Dermatitis | Drug: Placebo Drug: ZPL389 3mg Drug: ZPL389 10mg Drug: ZPL389 30mg Drug: ZPL389 50mg | Phase 2 |
A screening period of up to 4 weeks was followed by a 16-week double blinded treatment period.
After the end of treatment visit, subjects were offered the possibility of ongoing treatment in the extension study (CZPL389A2203E1/ NCT03948334), or of entering the 4 week treatment-free follow-up period.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 293 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-blind, Placebo-controlled Multicenter Dose Ranging Study to Assess the Safety and Efficacy of Multiple Oral ZPL389 Doses in Patients With Moderate to Severe Atopic Dermatitis (ZEST Trial) |
| Actual Study Start Date : | November 14, 2018 |
| Actual Primary Completion Date : | July 15, 2020 |
| Actual Study Completion Date : | August 6, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: placebo
Placebo
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Drug: Placebo
once daily from baseline until week 16 |
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Experimental: ZPL389 3mg
ZPL389 3 mg oral powder
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Drug: ZPL389 3mg
ZPL389 3 mg oral powder; once daily from baseline to week 16 |
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Experimental: ZPL389 10 mg
ZPL389 10 mg oral powder
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Drug: ZPL389 10mg
ZPL389 10 mg oral powder; once daily from baseline to week 16 |
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Experimental: ZPL389 30mg
ZPL389 30 mg oral powder
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Drug: ZPL389 30mg
ZPL389 30 mg oral powder; once daily from baseline to week 16 |
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Experimental: ZPL389 50mg
ZPL389 50 mg oral powder
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Drug: ZPL389 50mg
ZPL389 50 mg oral powder; once daily from baseline to week 16 |
- Percentage of IGA Responders at Week 16 [ Time Frame: 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.
- Percent Change From Baseline in EASI Score at Week 16 [ Time Frame: Baseline, Week 16 ]Eczema Area and Severity Index (EASI) is used to assess the extend and severity of atopic dermatitis on a scale from 0 to 72 where 72 is worst eczema.
- Percent Change From Baseline in EASI Score Over Time [ Time Frame: Baseline, Week 2, Week 4, Week 6, Week 8, Week 12 ]Eczema Area and Severity Index (EASI) is used to assess the extend and severity of atopic dermatitis on a scale from 0 to 72 where 72 is worst eczema.
- Percentage of EASI50 Responders Over Time [ Time Frame: Week 2, Week 4, Week 6, Week 8, Week 12, Week 16 ]
Eczema Area and Severity Index (EASI) is used to assess the extend and severity of atopic dermatitis on a scale from 0 to 72 where 72 is worst eczema.
EASI50 response is defined as achieving ≥ 50% improvement (reduction) in EASI score compared to 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 EASI as covariates
- Percentage of EASI75 Responders Over Time [ Time Frame: Week 2, Week 4, Week 6, Week 8, Week 12, Week 16 ]
Eczema Area and Severity Index (EASI) is used to assess the extend and severity of atopic dermatitis on a scale from 0 to 72 where 72 is worst eczema.
EASI75 response is defined as achieving ≥ 75% improvement (reduction) in EASI score compared to 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 EASI as covariates
- Percentage of IGA Responders Over Time [ Time Frame: Week 2, Week 4, Week 6, Week 8, Week 12 ]
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.
- Number of Patients With Adverse Events [ Time Frame: Up to week 20 ]An adverse event (AE) is any untoward medical occurrence (e.g., any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03517566
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| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Documents provided by Novartis ( Novartis Pharmaceuticals ):
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT03517566 |
| Other Study ID Numbers: |
CZPL389A2203 |
| First Posted: | May 7, 2018 Key Record Dates |
| Results First Posted: | July 20, 2021 |
| Last Update Posted: | October 8, 2021 |
| Last Verified: | October 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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atopic dermatitis AD eczema atopic eczema itch, pruritus histamine 4 receptor |
antagonist H4R ZPL389 ZPL389A2203 dermatitis |
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Dermatitis, Atopic Dermatitis Eczema Skin Diseases Skin Diseases, Genetic |
Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |