NCT02618616

Brief Summary

This was a randomized, double blind, placebo controlled, parallel group study in 129 subjects with moderate to severe psoriasis with a PASI score of at least 10. Following run-in, subjects were randomized and received either oral 30 mg ZPL-3893787 once daily or placebo once daily for 12 weeks.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_2

Geographic Reach
4 countries

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 1, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

January 11, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2016

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

July 20, 2021

Completed
Last Updated

July 20, 2021

Status Verified

June 1, 2021

Enrollment Period

12 months

First QC Date

November 27, 2015

Results QC Date

April 20, 2021

Last Update Submit

June 29, 2021

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

  • Percent Change From Baseline in Psoriasis Assessment of Severity Index (PASI) at Week 12

    The PASI is an assessment routinely used for evaluating and grading the severity of psoriatic lesions and their response to therapy. PASI divides the body into 4 regions: the head, trunk, upper extremities (arms) and lower extremities (legs). Each of these areas is assessed separately for erythema, in duration and scaling; these symptoms are scored on a 5-point scale from 0-4, where 0 = no symptoms and 4 =very marked. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents a reduction of at least 75% from baseline in the PASI score.

    From baseline to week 12

Secondary Outcomes (9)

  • PASI-50 and PASI-75 Responders at Week 12

    From baseline to week 12

  • Improvement in Investigator Global Assessment (IGA) at Week 12

    From baseline to week 12

  • Change From Baseline in the Numerical Rating Scale (NRS) for Pruritus (Worst Itch) at Week 12

    From baseline to week 12

  • Patient Global Impression of Change (PGIC) a Week 12

    From baseline to week 12

  • Change From Baseline in Body Surface Area (BSA) and Percentage Change From Baseline at Week 12

    From baseline to week 12

  • +4 more secondary outcomes

Study Arms (2)

ZPL-389

EXPERIMENTAL

Each subject was given 30 mg ZPL-3893787 capsules, to be taken orally once daily (OD) for 12 weeks.

Drug: ZPL-3893787

Placebo

PLACEBO COMPARATOR

Each subject was given 30 mg capsules of matching placebo, to be taken orally OD for 12 weeks.

Drug: Placebo

Interventions

ZPL-3893787DRUG
Also known as: ZPL389
ZPL-389
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A documented history of moderate to severe plaque psoriasis for at least 6 months prior to screening.
  • Male or female, aged ≥18 years.
  • Psoriasis Area and Severity Index (PASI) ≥10 at both Screening and Day 0.
  • An Investigator's Global Assessment (IGA) score ≥ 3 at both Screening and Day 0.
  • Psoriasis affecting ≥10% body surface area (BSA) at Screening and Day 0.

You may not qualify if:

  • Current diagnosis of Pustular, Guttate, Erythrodermic, exfoliative or only nail psoriasis or a diagnosis of inverse psoriasis without having plaque psoriasis.
  • Concurrent skin disease (e.g. acne) of such severity in the study area that it could interfere with the study evaluation or presence of skin comorbidities that may interfere with study assessments.
  • Active skin infections (e.g. impetigo, abscesses) or any other clinically apparent infections.
  • Biologic treatments for psoriasis (e.g. Enbrel, Humira, Stelara, Cosentyx) within 3 months of the start of the Run-In.
  • Phototherapy (e.g. UVA, UVB, PUVA) within 4 weeks of the start of the Run-In.
  • Oral calcineurin inhibitors and immunosuppressants (e.g. cyclosporine, azathioprine, methotrexate) within 4 weeks of the start of the Run-In.
  • Systemic corticosteroids within 4 weeks of the start of the Run-In.
  • Oral antihistamines and leukotriene inhibitors and tricyclic antidepressants within 1 week of the start of the Run-In.
  • Topical steroids (any potency), topical calcineurin inhibitors (tacrolimus, pimecrolimus), salicylic acid and urea containing treatments and coaltar preparations, topical and oral retinoids and vitamin D derivatives, within 1 week of the start of the Run-In.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Belgium Study Centre

Brussels, 1000, Belgium

Location

Belgium Study Centre

Brussels, 1090, Belgium

Location

Belgium Study Centre

Brussels, 1200, Belgium

Location

Belgium Study Centre

Ghent, 9000, Belgium

Location

Belgium Study Centre

Leuven, 3000, Belgium

Location

Belgium Study Centre

Liège, 4000, Belgium

Location

German Study Centre

Berlin, 10117, Germany

Location

German Study Centre

Goch, 47574, Germany

Location

German Study Centre

Hamburg, 20354, Germany

Location

German Study Centre

Hanover, 30625, Germany

Location

German Study Centre

Mainz, 55131, Germany

Location

German Study Centre

Münster, 48149, Germany

Location

Polish Study Centre

Bialystok, 15-430, Poland

Location

Polish Study Centre

Gdansk, 80-405, Poland

Location

Polish Study Centre

Lodz, 90-153, Poland

Location

Polish Study Centre

Lodz, 90-553, Poland

Location

Polish Study Centre

Lublin, 20-552, Poland

Location

Polish Study Centre

Poznan, 60-214, Poland

Location

Polish Study Centre

Tarnów, , 33-100, Poland

Location

Polish Study Centre

Wroclaw, 50-220, Poland

Location

UK Study Centre

Blackpool, FY2 0JH, United Kingdom

Location

UK Study Centre

Bridgetown, WS110BN, United Kingdom

Location

UK Study Centre

Leeds, WS110BN, United Kingdom

Location

UK Study Centre

Manchester, M13 9NQ, United Kingdom

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
Novartis.email@novartis.com
862-778-8300

Study Officials

  • Study Director

    Novartis

    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

November 27, 2015

First Posted

December 1, 2015

Study Start

January 11, 2016

Primary Completion

December 22, 2016

Study Completion

December 22, 2016

Last Updated

July 20, 2021

Results First Posted

July 20, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

PL(8)BE(6)GB(4)DE(6)