LEO 80185 in the Treatment of Psoriasis Vulgaris on the Non-scalp Regions of the Body (Trunk and/or Limbs)

Psoriasis Vulgaris Clinical Trial

Official title:

A Phase 3 Study Comparing Once Daily Treatment With Calcipotriol 50 mcg/g Plus Betamethasone 0.5 mg/g (as Dipropionate) Topical Suspension With Betamethasone 0.5 mg/g (as Dipropionate) in the Topical Suspension Vehicle, Calcipotriol 50 mcg/g in the Topical Suspension Vehicle and the Topical Suspension Vehicle Alone in Subjects With Psoriasis Vulgaris on Non-scalp Regions of the Body (Trunk and/or Limbs)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01188928
• Other study ID #: LEO 80185-G23
• Status: Completed
• Phase: Phase 3
• First received: August 25, 2010
• Last updated: March 25, 2015
• Start date: September 2010
• Est. completion date: March 2011

Study information

• Verified date: March 2015
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the efficacy and safety of Calcipotriol 50 Mcg/g Plus Betamethasone 0.5 mg/g (as Dipropionate) Topical Suspension with the active components when used individually as monotherapy in the topical suspension vehicle (betamethasone dipropionate in the topical suspension vehicle, calcipotriol in the topical suspension vehicle) and with the topical suspension vehicle alone in the treatment of psoriasis vulgaris on the non-scalp regions of the body (trunk and/or limbs) in a large phase 3 study. This comparison will ensure a more informed assessment of the benefit/risk ratio of Calcipotriol 50 Mcg/g Plus Betamethasone 0.5 mg/g (as Dipropionate) Topical Suspension while also establishing the optimal treatment duration in psoriasis vulgaris on the non-scalp regions of the body (trunk and/or limbs).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1152
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Signed and dated informed consent obtained prior to any trial related activities (including any washout period).

• Aged 18 years or above

• Either sex

• Any race or ethnicity

• Attending a hospital outpatient clinic or the private practice of a board certified dermatologist.

• Clinical diagnosis of stable plaque psoriasis vulgaris of at least 6 months duration involving the non-scalp regions of the body (trunk and/or limbs) amenable to treatment with a maximum of 100 g of topical medication per week.

• An investigator's global assessment of disease severity (IGA) of mild or moderate on the body (trunk and/or limbs) at Day 0 (Visit 1).

• A minimum modified Psoriasis Area and Severity Index (PASI) score for extent of 2 in at least one body region (i.e. psoriasis affecting at least 10% of arms, and/or 10% of trunk, and/or 10% of legs)

• Females of childbearing potential must have a negative pregnancy test at Day 0 (Visit 1).

• Females of childbearing potential must agree to use a highly effective method of birth control during the study. A highly effective method of birth control is defined as one which results in a low failure rate (less than 1% per year) such as implants, injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence or vasectomised partner. The patients must have used the contraceptive method continually for at least 1 month prior to the pregnancy test, and must continue using the contraceptive method for at least 1 week after the last application of study medication. A female is defined as not of child-bearing potential if she is postmenopausal (12 months with no menses without an alternative medical cause), or surgically sterile (tubal ligation/section, hysterectomy or bilateral ovariectomy).

• Able to communicate with the investigator and understand and comply with the requirements of the study.

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, alefacept, infliximab - within 2 months prior to randomisation

• ustekinumab - within 4 months prior to randomisation

• experimental products - within 4 weeks/5 half-lives (whichever is longer) prior to randomisation

• Systemic treatment with all other therapies with a possible effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, methotrexate, cyclosporine and other immunosuppressants) within 4 weeks prior to randomisation.

• PUVA or Grenz ray therapy within 4 weeks prior to randomisation.

• UVB therapy within 2 weeks prior to randomisation.

• Any topical treatment of the trunk and/or limbs (except for emollients) within 2 weeks prior to randomisation.

• Topical treatment for other relevant skin disorders on the face and flexures (e.g., facial and flexural psoriasis, eczema) with class 1- 5 corticosteroids or vitamin D analogues within 2 weeks prior to randomisation.

• Topical treatment for other relevant skin disorders on the scalp (e.g. scalp psoriasis) with class 1-5 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, anti-malarials, lithium, ACE inhibitors) during the study.

• Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.

• Subjects with any of the following conditions present on the treatment area: viral (e.g. herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, icthyosis, acne rosacea, ulcers and wounds.

• Known or suspected disorders of calcium metabolism associated with hypercalcaemia.

• Known or suspected severe renal insufficiency or severe hepatic disorders.

• Known or suspected hypersensitivity to component(s) of the investigational products.

• Current participation in any other interventional clinical study.

• Subjects who have received treatment with any non-marketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within the 4-week period prior to randomisation or longer, if the class of substance required a longer washout as defined above (e.g. biological treatments).

• Planned excessive exposure to the sun during the study that may affect the psoriasis vulgaris.

• Previously randomised in this study.

• Females who are pregnant, have a positive pregnancy test at Day 0 (Visit 1), or are breast-feeding. Females of child-bearing potential wishing to become pregnant during the study, or not using an adequate method of contraception during the study.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

Drug:
• Calcipotriol plus betamethasone
Topical suspension once daily for up to 8 weeks.
• Betamethasone-17,21-dipropionate
Topical suspension once daily for up to 8 weeks.
• Calcipotriene
Topical suspension once daily for up to 8 weeks.
• Topical suspension vehicle
Topical suspension once daily for up to 8 weeks.

Locations

Country	Name	City	State
United States	Academic Dermatology Associates	Albuquerque	New Mexico
United States	Atlanta Dermatology, Vein & Research Center	Alpharetta	Georgia
United States	Advanced Clinical Research Institute	Anaheim	California
United States	David Fivenson, MD Dermatology, PLC	Ann Arbor	Michigan
United States	Altman Dermatology Associates	Arlington Hts	Illinois
United States	Peachtree Dermatology Associates	Atlanta	Georgia
United States	Great Lakes Research Group, Inc	Bay City	Michigan
United States	Visions Clinical Research	Boynton Beach	Florida
United States	Glazer Dermatology	Buffalo Grove	Illinois
United States	Triangle Medical Research Associates, LLC	Cary	North Carolina
United States	Michigan Center for Research Corp.,	Clinton Twp	Michigan
United States	J&S Studies, Inc.	College Station	Texas
United States	Dermatology Associates and Research	Coral Gables	Florida
United States	Division of Dermatology, Baylor Research Institute	Dallas	Texas
United States	Colorado Medical Research Center, Inc.	Denver	Colorado
United States	Horizons Clinical Research Center, LLC	Denver	Colorado
United States	Henry Ford Health System	Detroit	Michigan
United States	Psoriasis Treatment Center of Central NJ	East Windsor	New Jersey
United States	Anderson & Collins Clinical Research, Inc.	Edison	New Jersey
United States	Deaconess Clinic, Inc.	Evansville	Indiana
United States	Hudson Dermatology	Evansville	Indiana
United States	Hamzavi Dermatology	Fort Gratiot	Michigan
United States	Minnesota Clinical Study Center	Fridley	Minnesota
United States	Karl G. Heine, M. D. Dermatology	Henderson	Nevada
United States	Burke Pharmaceutical Research	Hot Springs	Arkansas
United States	Centre for Clinical Studies	Houston	Texas
United States	Dawes Fretzin Clinical Research Group	Indianapolis	Indiana
United States	North Florida Dermatology Associates, PA	Jacksonville	Florida
United States	King-Maceyko Dermatology Associates	Johnstown	Pennsylvania
United States	DBA Torrance Clinical Research	Lomita	California
United States	Dermatology Specialists	Louisville	Kentucky
United States	Dermatologic Surgery Specialists, PC	Macon	Georgia
United States	International Dermatology Research, Inc.	Miami	Florida
United States	Horizon Research Group, Inc	Mobile	Alabama
United States	Mount Sinai School of Medicine	New York	New York
United States	Dermatology Specialists, Inc.	Oceanside	California
United States	Ameriderm Research	Ormond Beach	Florida
United States	Owensboro Dermatology Associates	Owensboro	Kentucky
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Indiana Clinical Trials Center	Plainfield	Indiana
United States	Oregon Dermatology and Research Center	Portland	Oregon
United States	Lawrence J. Green, MD, LLC	Rockville	Maryland
United States	Dermatology Research Center, Inc.	Salt Lake City	Utah
United States	Clinical Trials of Texas, Inc.	San Antonio	Texas
United States	Dermatology Clinical Research Center of San Antonio	San Antonio	Texas
United States	Progressive Clinical Research, P.A.	San Antonio	Texas
United States	Skin Surgery Medical Group, Inc.	San Diego	California
United States	Walter Nahm, MD, Ph.D., Inc	San Diego	California
United States	Coastal Medical Research Group, Inc.	San Luis Obispo	California
United States	Clinical Science Institute	Santa Monica	California
United States	Dermatology Research Centers	Santa Monica	California
United States	Gwinnett Clinical Research Center, Inc	Snellville	Georgia
United States	Haber Dermatology and Cosmetic Surgery	South Euclid	Ohio
United States	Premier Clinical Research	Spokane	Washington
United States	Derm Research Center of New York	Stony Brook	New York
United States	Somerset Skin Centre	Troy	Michigan
United States	The Dermatology Group, PC	Verona	New Jersey
United States	Grekin Skin Institute	Warren	Michigan
United States	Palm Beach Research Center	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Controlled Disease According to the Investigator's Global Assessment of Disease Severity (IGA) at Weeks 4	The IGA was chosen as the primary efficacy assessment. The primary endpoint is subjects with 'Controlled disease' according to the IGA. 'Controlled disease' is defined as clear or almost clear for subjects with moderate disease at baseline and clear for subjects with mild disease at baseline.	4 weeks	No
Primary	Controlled Disease According to the Investigator's Global Assessment of Disease Severity (IGA) at Weeks 8	The IGA was chosen as the primary efficacy assessment. The primary endpoint is subjects with 'Controlled disease' according to the IGA. 'Controlled disease' is defined as clear or almost clear for subjects with moderate disease at baseline and clear for subjects with mild disease at baseline.	week 8	No
Secondary	Mean Percentage Change in PASI From Baseline to Week 4	At all treatment phase visits the (sub)investigator made an assessment of the extent and severity of clinical signs of the subject's psoriasis using a modified PASI score (Psoriasis Area and Severity Index) To make up the score, the three features of a psoriatic plaque redness, scaling and thickness are each assigned a number from 0 to 4 with 4 being worst. The extent of involvement of each region of the body is scored from 0 to 6. Adding up the scores give a range of 0 to 72.	Baseline and 4 weeks	No
Secondary	Mean Percentage Change in PASI From Baseline to Week 8	At all treatment phase visits the (sub)investigator made an assessment of the extent and severity of clinical signs of the subject's psoriasis using a modified PASI score (Psoriasis Area and Severity Index) To make up the score, the three features of a psoriatic plaque redness, scaling and thickness are each assigned a number from 0 to 4 with 4 being worst. The extent of involvement of each region of the body is scored from 0 to 6. Adding up the scores give a range of 0 to 72.	Baseline and 8 weeks	No

External Links

•   Clinical Trials at LEO Pharma