Mode
Text Size
Log in / Sign up
Phase 3 N=426 Randomized Quadruple-blind Treatment

LEO 90100 Compared to Vehicle in Subjects With Psoriasis Vulgaris

Psoriasis Vulgaris

Enrolled (actual)
426
Serious AEs
0.5%
Results posted
May 2016
Primary outcome: Primary: Treatment Success According to IGA — 53.3; 4.8 percentage of subjects — p=<0.001

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
LEO 90100 (Drug); Vehicle (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
LEO Pharma
Primary completion
Oct 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Treatment Success According to IGA
53.3; 4.8 <0.001 sig
SECONDARY
m-PASI at Week 4
2.04; 5.33 <0.001 sig
SECONDARY
m-PASI at Week 1
4.66; 5.93 <0.001 sig

Summary

The purpose of this trial is to compare the efficacy of treatment with LEO 90100 to that of treatment with vehicle for up to 4 weeks in subjects with psoriasis vulgaris.

Eligibility Criteria

Inclusion Criteria

  • A clinical diagnosis of psoriasis vulgaris of at least 6 months duration involving the trunk and/or limbs
  • Psoriasis vulgaris on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) involving 2-30% of the Body Surface Area (BSA)
  • An Investigator's Global Assessment of disease severity (IGA) of at least mild at Day 0 (Visit 1)
  • A modified PASI (m-PASI) score of at least 2 at Day 0 (Visit 1)
  • A target lesion of a minimum of 5 cm at its longest axis and preferably not located on the extensor surface on an elbow or knee, scoring at least 1 for each of redness, thickness and scaliness, and at least 4 in total by the Investigator's Assessment of Severity of the Target Lesion

Exclusion Criteria

  • Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to randomisation:
  • etanercept - within 4 weeks prior to randomisation
  • adalimumab, infliximab - within 8 weeks prior to randomisation
  • ustekinumab - within 16 weeks prior to randomisation
  • other products - within 4 weeks/5 half-lives prior to randomisation (whichever is longer)
  • Systemic treatment with all other therapies with a possible effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, methotrexate, ciclosporin and other immunosuppressants) within 4 weeks prior to randomisation.
  • Subjects who have received treatment with any nonmarketed drug substance (i.e. a drug which has not yet been made available for clinical use following registration) within 4 weeks/5 half-lives (whichever is longer) prior to randomisation.
  • PUVA therapy within 4 weeks prior to randomisation.
  • UVB therapy within 2 weeks prior to randomisation.
  • Topical anti-psoriatic treatment on the trunk and limbs (except for emollients) within 2 weeks prior to randomisation.
  • Topical treatment on the face, scalp and skin folds with corticosteroids, vitamin D analogues or prescription shampoos within 2 weeks prior to randomisation.
  • Planned initiation of, or changes to, concomitant medication that could affect psoriasis vulgaris (e.g. beta blockers, antimalarial drugs, lithium, ACE inhibitors) during the trial.
  • Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.
  • Previously randomised in this trial or any previously conducted trial of LEO 90100.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01866163). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search