Efficacy of Alitretinoin Treatment in Patients With Pustular Form of Psoriasis

NCT01245140 | Completed Phase 2 Results

• 3 other identifiers: 1172212010-022843-39BAP02028
• Study Type: interventional
• Target: 33
• Locations: 4 countries
• Sites: 8

Brief Summary

The main purpose of this study is to demonstrate the improvement in the skin condition rate of patients receiving alitretinoin compared to patients receiving placebo.

Conditions

Psoriasis

Keywords

Palmo-Plantar Pustolosis

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in the Palmo-plantar Pustulosis Psoriasis Area and Severity Index (PPPASI) Score at the End of Treatment (EOT) (Week 24) or at the Last Assessment

  The investigator evaluated the PPPASI score on a 5-point scale. The parameters of erythema, total number of pustules, and desquamation were scored for the right/left palm and the right/left sole. After correcting the scores for area (based on a 7-point scale) and the site involved (palm or sole), the PPPASI score per palm/sole was produced. The final PPPASI score was calculated as the sum of the PPPASI score for the right sole + the PPPASI score for the left sole + the PPPASI score for the right palm + the PPPASI score for the left palm and ranges from 0 (no palmo-plantar pustulosis psoriasis \[PPP\]) to 72 (most severe PPP). Change from Baseline is defined as value at the EOT minus the Baseline value.

  Baseline and EOT (Week 24) or the last assessment

• Number of Participants With PPPASI 50 Response and PPPASI 75 Response

  The investigator evaluated the PPPASI score on a 5-point scale. The parameters of erythema, total number of pustules, and desquamation were scored for the right/left palm and the right/left sole. After correcting the scores for area (based on a 7-point scale) and the site involved (palm or sole), the PPPASI score per palm/sole was produced. The final PPPASI score was calculated as the sum of the PPPASI score for the right sole + the PPPASI score for the left sole + the PPPASI score for the right palm + the PPPASI score for the left palm and ranges from 0 (no palmo-plantar pustulosis psoriasis \[PPP\]) to 72 (most severe PPP). Change from Baseline is defined as value at the EOT minus the Baseline value. PPPASI 50 response and PPPASI 75 response are defined as a 50% and 75% decrease, respectively, in the PPPASI score from Baseline.

  From Baseline until EOT (Week 24) or the last assessment

Secondary Outcomes (23)

• Total Pustule Count at Baseline; Weeks 4, 8, 12, 16, and 20; and at EOT (Week 24)

  Baseline; Weeks 4, 8, 12, 16, and 20; and EOT (Week 24)

• Absolute Change From Baseline (BL) in Total Pustule Count at Weeks 4, 8, 12, 16, and 20 and at EOT (Week 24)

  Baseline; Weeks 4, 8, 12, 16, and 20; and EOT (Week 24)

• Mean Modified Psoriasis Area Severity Index (mPASI) Score at Baseline; Weeks 4, 8, 12, 16, and 20; and EOT (Week 24)

  Baseline; Weeks 4, 8, 12, 16, and 20; and EOT (Week 24)

• Change From Baseline in the mPASI Score at EOT (Week 24) or at the Last Assessment

  Baseline and EOT (Week 24) or the last assessment

• Number of Participants With mPASI 50 Response and mPASI 75 Response

  From Baseline until EOT (Week 24)

Study Arms (2)

Active

ACTIVE COMPARATOR

to receive study drug (alitretinoin, 20 patients)

Drug: alitretinoin

Placebo

PLACEBO COMPARATOR

to receive placebo (dummy drug, 10 patients)

Drug: Placebo

Interventions

alitretinoin DRUG

to receive verum (20 patients)

Also known as: Toctino

Active

Placebo DRUG

to receive placebo (10 patients)

Placebo

Eligibility Criteria

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

You may qualify if:

• A female subject is eligible to participate if she is of:
• Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea and a follicle stimulating hormone concentration of ≥40 international units (IU)/L.
• Child-bearing potential with negative pregnancy test as determined by human chorionic gonadotropin (hCG) test at screening or prior to dosing and either 1) agrees to use a medically acceptable contraception method for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point and continue contraception until the end of the study, or 2) has only same-sex partners, when this is her preferred and usual lifestyle.
• Capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol specific procedures are performed.
• Male or female aged at least 18 years at time of consent and at time of first dose.
• Have PPP for at least 6 months, with or without psoriasis lesions on other areas of the skin
• A PPPASI score of at least 8 with involvement of at least 10% of the palms and/or the soles
• Refractory to standard topical corticosteroid therapy

You may not qualify if:

• Unable to comply with the requirement of the study
• Female subjects who are pregnant or who plan to become pregnant or who are breast feeding
• Subjects whose disease is adequately controlled by standard non-medicated therapy (skin moisturizing and protection)
• Known hypersensitivity to other retinoids or vitamin A derivatives, or to any study medication component, especially soybean oil and partly hydrogenated soybean oil
• Treated with any of the following treatments 4 weeks before the start of study treatment:
• systemic drugs: corticosteroids, immunosuppressants, methotrexate
• phototherapy: ultraviolet B light therapy \[UVB\], psoralen with ultraviolet A combination therapy \[PUVA\], Grenz rays, X-rays
• Treated with biologic treatments within 6 weeks prior to start of study treatment.
• Abnormal hematology
• Treated with any systemic or topical retinoids within 3 months or 1 month, respectively, before start of study treatment
• Treated with high-potency topical corticosteroids within 2 weeks before the start of study treatment
• Severe generalized pustular psoriasis
• A skin condition of palms and/or soles that interferes with the diagnosis of PPP by the investigator
• Any condition that, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study.
• Hepatic insufficiency, severe renal failure, uncontrolled hypercholesterolemia as characterized by:

Sponsors & Collaborators

• Stiefel, a GSK Company: lead
• Basilea Pharmaceutica: collaborator

Study Sites (8)

GSK Investigational Site

Paris, 75475, France

Location

GSK Investigational Site

Munich, Bavaria, 80337, Germany

Location

GSK Investigational Site

Witten, North Rhine-Westphalia, 58453, Germany

Location

GSK Investigational Site

Berlin, 10117, Germany

Location

GSK Investigational Site

Berlin, 10827, Germany

Location

GSK Investigational Site

Hamburg, 20354, Germany

Location

GSK Investigational Site

Nijmegen, 6525 GA, Netherlands

Location

GSK Investigational Site

London, SE1 7EH, United Kingdom

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Psoriasis

Interventions

Alitretinoin

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Tretinoin; Vitamin A; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  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 16, 2010
• First Posted: November 22, 2010
• Study Start: April 26, 2011
• Primary Completion: March 12, 2014
• Study Completion: April 16, 2014
• Last Updated: December 21, 2017
• Results First Posted: April 4, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will share

Locations

FR (1); NL (1); DE (5); GB (1)