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Efficacy and Safety of Oral Alitretinoin (Toctino®) in the Treatment of Patients With Cutaneous Lupus Erythematosus (AliCLE)

This study has been terminated.
Sponsor:
Collaborator:
Basilea Pharmaceutica International Ltd
Information provided by (Responsible Party):
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT01407679
First received: August 1, 2011
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

To evaluate the therapeutic effect of oral alitretinoin (Toctino®) in the treatment of CLE with respect to proportion of responders based on the Revised Cutaneous Lupus Disease Area and Severity Index (RCLASI) activity score for skin lesions at baseline and after 24 weeks of treatment or at the latest assessment for patients who withdrew prematurely. Response is defined as a reduction of 50% in the total RCLASI compared to the baseline value ("RCLASI 50").


Condition Intervention Phase
Lupus Erythematosus, Cutaneous
Drug: Alitretinoin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Oral Alitretinoin (Toctino®) in the Treatment of Patients With Cutaneous Lupus Erythematosus: A Multicentre, Open-Label, Prospective Pilot Study

Resource links provided by NLM:


Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:
  • Primary efficacy outcome is the response rate at week 24 or at the latest assessment for patients who withdrew prematurely. [ Time Frame: Week 24 or at the latest assessment for patients who withdrew prematurely. ] [ Designated as safety issue: No ]
    Response is defined as a reduction of 50% in the total RCLASI activity for skin lesions, compared to the baseline value ("RCLASI 50")


Secondary Outcome Measures:
  • Proportion of patients with RCLASI 50 at week 12 of treatment. [ Time Frame: Week 12 of treatment ] [ Designated as safety issue: No ]
  • Proportion of patients with at least partial response at end of therapy (with regard to RCLASI activity score for skin lesions). [ Time Frame: End of therapy (up to 24 weeks) ] [ Designated as safety issue: No ]
  • Patient's global assessment and VAS for itch and pain 12 weeks after the beginning of treatment. [ Time Frame: 12 weeks after the beginning of treatment ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events (AEs) and their severity. [ Time Frame: 24 weeks of treatment + 5 weeks of follow up ] [ Designated as safety issue: Yes ]
  • Patient's global assessment and VAS for itch and pain at the end of therapy. [ Time Frame: End of therapy (up to 24 weeks) ] [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: August 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alitretinoin Drug: Alitretinoin
1 capsule Alitretinoin 30 mg per day; optional reduction to 10 mg per day in case unacceptable adverse reactions to the higher dose occur
Other Names:
  • Alitretinoin 30 mg soft capsules
  • Alitretinoin 10 mg soft capsules

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A clinical and histological diagnosis of CLE (DLE, SCLE, LET) who failed to respond to topical corticosteroids;
  • Total RCLASI activity score of skin lesions >6 (at least 3 points in at least 2 locations);
  • At least one primary but preferably 2 methods of contraception;

Exclusion Criteria:

  • Systemic Lupus Erythematosus (SLE) with major systemic organ involvement, e.g. clinical significant renal involvement, requiring systemic medical treatment for the disease;
  • Clinically significant illness that may influence the outcome of the study in the four weeks before and during the study;
  • Active severe infection diseases, including chronic or localized;
  • Patients with hepatic insufficiency (AST, ALT > 2.5 x ULN), severe renal failure (creatinine clearance < 60ml/min), or hypercholesterolemia characterized by:

    1. Fasting triglyceridemia > 1.5 x upper limit of normal (ULN)
    2. Fasting total cholesterol > 1.5 x ULN
    3. Fasting low-density lipoprotein (LDL) cholesterol > 1.5x ULN
  • Patients with known hypersensitivity to other retinoids or vitamin A derivatives, or to any study medication component, especially soybean oil and partly hydrogenated soybean oil;
  • Patients with cardiovascular risk factors that would exclude a starting dose of 30 mg of alitretinoin;
  • Topical corticosteroids within 14 days prior to dosing;
  • Patients treated with any systemic or topical retinoids within 4 weeks before start of study treatment;
  • Drugs with a potential for drug-drug interaction, such as systemic tetracyclines, ketoconazole, or St. John‟s Wort within 1 week, or receiving systemic itraconazole within 2 weeks, before start of study treatment;
  • Initiation or change in the dose of any current systemic medication for the treatment of CLE/SLE prior to the study (time depending on drug class and half-life);
  • Treatment with immunosuppressive drugs for other reasons, 4 weeks prior and within the study;
  • Concomitant medication with drugs with a known photosensitizing potential, e.g. tetracyclines, griseofulvin, thiazides, furosemide, sulfonamides or tolbutamide;
  • Drugs associated to CLE-induction: terbinafine, hydrochlorothiazide, diltiazem, verapamil, nifedipine, nitrendipine, fluorouracil, penicillamine, infliximab, adalimumab, etanercept, pantoprazole;

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01407679

Locations
Germany
Department of Dematology, University Hospital
Mannheim, Baden-Wuerttemberg, Germany, 68167
Department of Dermatology, Ludwig-Maximilians University
Muenchen, Bayern, Germany, 80337
Department of Dermatology, University Hospital
Muenster, Westfalen, Germany, 48149
Sponsors and Collaborators
University Hospital Muenster
Basilea Pharmaceutica International Ltd
Investigators
Principal Investigator: Annegret Kuhn, Prof. Dr. Department of Dermatology, University Hospital Muenster, Muenster, Germany
  More Information

No publications provided

Responsible Party: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT01407679     History of Changes
Other Study ID Numbers: UKM 10_0019
Study First Received: August 1, 2011
Last Updated: May 21, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Muenster:
cutaneous lupus erythematosus
discoid lupus erythematosus
subacute cutaneous lupus erythematosus
lupus erythematosus tumidus

Additional relevant MeSH terms:
Lupus Erythematosus, Cutaneous
Lupus Erythematosus, Systemic
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Skin Diseases
Alitretinoin
Tretinoin
Antineoplastic Agents
Dermatologic Agents
Keratolytic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014