Atopic DermatitisPhase 2NCT03517566
A Study to Assess the Safety and Efficacy of ZPL389 in Patients With Moderate to Severe Atopic Dermatitis
A Phase 2 study testing ZPL389 3mg, ZPL389 10mg and ZPL389 30mg in people with Atopic Dermatitis, run by Novartis Pharmaceuticals at 89 sites in 16 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- ZPL389 3mg, ZPL389 10mg and ZPL389 30mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 293 participants
- Where
- 89 sitesin 16 countries
- Study dates
- 14 Nov 2018to 6 Aug 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
89 sites in 16 countries.
89 sites in 16 countries
Russia16 sites
Novartis Investigative Site
Chelyabinsk, 454092
Novartis Investigative Site
Kazan', 420012
Novartis Investigative Site
Krasnodar, 350020
Novartis Investigative Site
Moscow, 123182
Novartis Investigative Site
Petrozavodsk, 185019
Novartis Investigative Site
Saint Petersburg, 191123
Novartis Investigative Site
Saint Petersburg, 192007
Novartis Investigative Site
Saint Petersburg, 194223
Novartis Investigative Site
Saint Petersburg, 194325
Novartis Investigative Site
Saint Petersburg, 196143
Novartis Investigative Site
Saint Petersburg, 196240
Novartis Investigative Site
Saint Petersburg, 197136
Novartis Investigative Site
Smolensk, 214019
Novartis Investigative Site
Stavropol, 355020
Novartis Investigative Site
Yekaterinburg, 620023
Novartis Investigative Site
Yekaterinburg, 620109
Germany13 sites
Novartis Investigative Site
Bielefeld, 33647
Novartis Investigative Site
Braunschweig, 38100
Novartis Investigative Site
Frankfurt, 60590
Novartis Investigative Site
Gera, 07548
Novartis Investigative Site
Halle, 06108
Novartis Investigative Site
Hamburg, 20537
Novartis Investigative Site
Hamburg, 22391
Novartis Investigative Site
Hanover, 30625
Novartis Investigative Site
Heidelberg, 69120
Novartis Investigative Site
Memmingen, 87700
Novartis Investigative Site
München, 80337
Novartis Investigative Site
Münster, 48149
Novartis Investigative Site
Osnabrück, 49074
Japan13 sites
Novartis Investigative Site
Fukuoka, 819 0167
Novartis Investigative Site
Fukuoka, 819-0373
Novartis Investigative Site
Kobe, Hyōgo, 654 0011
Novartis Investigative Site
Kyoto, 606 8507
Novartis Investigative Site
Nagoya, Aichi-ken, 467-8602
Novartis Investigative Site
Sakai, Osaka, 593-8324
Novartis Investigative Site
Sapporo, Hokkaido, 060-0063
Novartis Investigative Site
Shinagawa Ku, Tokyo, 141 8625
Novartis Investigative Site
Shinjuku Ku, Tokyo, 162 8655
Novartis Investigative Site
Shinjuku-ku, Tokyo, 160-0023
Novartis Investigative Site
Tokyo, 158 0097
Novartis Investigative Site
Yokohama, Kanagawa, 220-6208
Novartis Investigative Site
Yokohama, Kanagawa, 221-0825
United States12 sites
Novartis Investigative Site
Cincinnati, Ohio, 45231
Novartis Investigative Site
Fairborn, Ohio, 45324
Novartis Investigative Site
Fountain Valley, California, 92708
Novartis Investigative Site
Greer, South Carolina, 29651
Novartis Investigative Site
Houston, Texas, 77004
Novartis Investigative Site
Litchfield Park, Arizona, 85340
Novartis Investigative Site
Louisville, Kentucky, 40217
Novartis Investigative Site
San Diego, California, 92103
Novartis Investigative Site
San Diego, California, 92123
Novartis Investigative Site
Tampa, Florida, 33609
Novartis Investigative Site
Tampa, Florida, 33612
Novartis Investigative Site
West Jordan, Utah, 84088
Canada5 sites
Novartis Investigative Site
Markham, Ontario, L3P 1A8
Novartis Investigative Site
Newmarket, Ontario, L3Y 5G8
Novartis Investigative Site
Sainte-Hyacinthe, Quebec, J2S 66
Novartis Investigative Site
Toronto, Ontario, M4V 1R2
Novartis Investigative Site
Waterloo, Ontario, N2J 1C4
United Kingdom5 sites
Novartis Investigative Site
Dudley, West Midlands, DY1 2HQ
Novartis Investigative Site
Liverpool, L14 3PE
Novartis Investigative Site
London, SE1 9RT
Novartis Investigative Site
Plymouth, Devon, PL6 8DH
Novartis Investigative Site
Portsmouth, PO3 6AD
Czechia4 sites
Novartis Investigative Site
Karlovy Vary, Czech Republic, 36001
Novartis Investigative Site
Nový Jičín, Czech Republic, 74101
Novartis Investigative Site
Prague, Prague 1, 11000
Novartis Investigative Site
Prague, 100 00
Netherlands4 sites
Novartis Investigative Site
Bergen op Zoom, 4624 VT
Novartis Investigative Site
Breda, 4818 CK
Novartis Investigative Site
Groningen, 9713 GZ
Novartis Investigative Site
Rotterdam, 3015 CE
Poland4 sites
Novartis Investigative Site
Katowice, 40-648
Novartis Investigative Site
Rzeszów, 35 055
Novartis Investigative Site
Warsaw, Mazowian, 02 495
Novartis Investigative Site
Warsaw, 04141
Slovakia4 sites
Novartis Investigative Site
Bardejov, SVK, 085 01
Novartis Investigative Site
Bratislava, 85101
Novartis Investigative Site
Levice, 934 01
Novartis Investigative Site
Svidník, 08901
Finland3 sites
Novartis Investigative Site
Helsinki, 00250
Novartis Investigative Site
Tampere, 33520
Novartis Investigative Site
Turku, 20520
Taiwan2 sites
Novartis Investigative Site
Taichung, Taiwan ROC, 40201
Novartis Investigative Site
Taipei, 10002
About this study
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)
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
Read the detailed description
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.
- Conditions
- Atopic Dermatitis
- Being tested
- Placebo, ZPL389 3mg, ZPL389 10mg, ZPL389 30mg, ZPL389 50mg
- Keywords
- atopic dermatitis, AD, eczema, atopic eczema, itch, pruritus, histamine 4 receptor, antagonist, H4R, ZPL389, ZPL389A2203, dermatitis
- Medical subject headings
- Dermatitis, Atopic, Eczema, Pruritus, Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
once daily from baseline until week 16
ZPL389 3mgDrug
ZPL389 3 mg oral powder; once daily from baseline to week 16
ZPL389 10mgDrug
ZPL389 10 mg oral powder; once daily from baseline to week 16
ZPL389 30mgDrug
ZPL389 30 mg oral powder; once daily from baseline to week 16
ZPL389 50mgDrug
ZPL389 50 mg oral powder; once daily from baseline to week 16
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| ZPL389 3mg | Experimental | ZPL389 3 mg oral powder Receives: Drug: ZPL389 3mg |
| ZPL389 10 mg | Experimental | ZPL389 10 mg oral powder Receives: Drug: ZPL389 10mg |
| ZPL389 30mg | Experimental | ZPL389 30 mg oral powder Receives: Drug: ZPL389 30mg |
| ZPL389 50mg | Experimental | ZPL389 50 mg oral powder Receives: Drug: ZPL389 50mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 16
Secondary outcomes (6)
Percent Change From Baseline in EASI Score at 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.
Measured: Baseline, Week 16
Percent Change From Baseline in EASI Score Over Time
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.
Measured: Baseline, Week 2, Week 4, Week 6, Week 8, Week 12
Percentage of EASI50 Responders Over Time
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
Measured: Week 2, Week 4, Week 6, Week 8, Week 12, Week 16
Percentage of EASI75 Responders Over Time
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
Measured: Week 2, Week 4, Week 6, Week 8, Week 12, Week 16
Percentage of IGA Responders Over Time
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.
Measured: Week 2, Week 4, Week 6, Week 8, Week 12
Number of Patients With Adverse Events
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.
Measured: Up to week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2018
- Study start14 Nov 2018
- Primary completion15 Jul 2020
- Study completion6 Aug 2020
Why it stopped: Lack of efficacy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 293 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03517566
- Sponsor's protocol ID
- CZPL389A2203
- Status last verified
- Oct 2021
- First submitted
- 27 Mar 2018
- Last updated
- 8 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03517566
- Acronym / sponsor ID
- CZPL389A2203
- Conditions
- Atopic Dermatitis
- Keywords
- atopic dermatitis, AD, eczema, atopic eczema, itch, pruritus, histamine 4 receptor, antagonist, H4R
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of efficacy
- Enrolment
- 293 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 14 Nov 2018 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 6 Aug 2020 (actual)
- First posted
- 7 May 2018 (actual)
- Results
- Posted 20 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: PlaceboPlacebo |
| ZPL389 3mg | Experimental | Drug: ZPL389 3mgZPL389 3 mg oral powder |
| ZPL389 10 mg | Experimental | Drug: ZPL389 10mgZPL389 10 mg oral powder |
| ZPL389 30mg | Experimental | Drug: ZPL389 30mgZPL389 30 mg oral powder |
| ZPL389 50mg | Experimental | Drug: ZPL389 50mgZPL389 50 mg oral powder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placeboonce daily from baseline until week 16 | Drug | placebo |
| ZPL389 3mgZPL389 3 mg oral powder; once daily from baseline to week 16 | Drug | ZPL389 3mg |
| ZPL389 10mgZPL389 10 mg oral powder; once daily from baseline to week 16 | Drug | ZPL389 10 mg |
| ZPL389 30mgZPL389 30 mg oral powder; once daily from baseline to week 16 | Drug | ZPL389 30mg |
| ZPL389 50mgZPL389 50 mg oral powder; once daily from baseline to week 16 | Drug | ZPL389 50mg |
Primary outcome
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.
6 secondary outcomes
Percent Change From Baseline in EASI Score at Week 16
Time frame: Baseline, Week 16
Percent Change From Baseline in EASI Score Over Time
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8, Week 12
Percentage of EASI50 Responders Over Time
Time frame: Week 2, Week 4, Week 6, Week 8, Week 12, Week 16
Percentage of EASI75 Responders Over Time
Time frame: Week 2, Week 4, Week 6, Week 8, Week 12, Week 16
Percentage of IGA Responders Over Time
Time frame: Week 2, Week 4, Week 6, Week 8, Week 12
Number of Patients With Adverse Events
Time frame: Up to week 20
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- A Plain Language Trial Summary is available on novartisclinicaltrials.comLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
89 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ZPL389 3mg, ZPL389 10mg and ZPL389 30mg in people with Atopic Dermatitis, run by Novartis Pharmaceuticals at 89 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 89 sites in Russia, Germany, Japan, United States, Canada and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of IGA Responders at Week 16 (time frame: Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2021.