## Protocol Section
### Identification Module
**NCT ID:** NCT01407679

**Acronym:** AliCLE

**Brief Title:** Efficacy and Safety of Oral Alitretinoin (Toctino®) in the Treatment of Patients With Cutaneous Lupus Erythematosus

**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

#### Organization Study ID Info
**ID:** UKM 10_0019
#### Organization
**Class:** OTHER
**Full Name:** University Hospital Muenster
### Status Module
#### Completion Date
**Date:** 2014-04

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-06-01

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-05-30

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2014-04

**Type:** ACTUAL

#### Start Date
**Date:** 2011-08

**Status Verified Date:** 2016-05

#### Study First Post Date
**Date:** 2011-08-02
**Type:** ESTIMATED
**Study First Submit Date:** 2011-08-01
**Study First Submit QC Date:** 2011-08-01
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Basilea Pharmaceutica International Ltd

#### Lead Sponsor

**Class:** OTHER

**Name:** University Hospital Muenster

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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").

### Conditions Module

**Conditions:**

- Lupus Erythematosus, Cutaneous

**Keywords:**

- cutaneous lupus erythematosus

- discoid lupus erythematosus

- subacute cutaneous lupus erythematosus

- lupus erythematosus tumidus

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 7

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: Alitretinoin

**Label:** Alitretinoin

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Alitretinoin

**Description:** 1 capsule Alitretinoin 30 mg per day; optional reduction to 10 mg per day in case unacceptable adverse reactions to the higher dose occur

**Name:** Alitretinoin

**Other Names:**

- Alitretinoin 30 mg soft capsules

- Alitretinoin 10 mg soft capsules

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Response is defined as a reduction of 50% in the total RCLASI activity for skin lesions, compared to the baseline value ("RCLASI 50")

**Measure:** 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.

#### Secondary Outcomes

**Measure:** Proportion of patients with RCLASI 50 at week 12 of treatment.

**Time Frame:** Week 12 of treatment

**Measure:** 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)

**Measure:** 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

**Measure:** Number of Participants with Adverse Events (AEs) and their severity.

**Time Frame:** 24 weeks of treatment + 5 weeks of follow up

**Measure:** Patient's global assessment and VAS for itch and pain at the end of therapy.

**Time Frame:** End of therapy (up to 24 weeks)

### Eligibility Module

**Eligibility 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

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Mannheim

**Country:** Germany

**Facility:** Department of Dematology, University Hospital

**State:** Baden-Wuerttemberg

**Zip:** 68167

**Location 2:**

**City:** Muenchen

**Country:** Germany

**Facility:** Department of Dermatology, Ludwig-Maximilians University

**State:** Bayern

**Zip:** 80337

**Location 3:**

**City:** Muenster

**Country:** Germany

**Facility:** Department of Dermatology, University Hospital

**State:** Westfalen

**Zip:** 48149

#### Overall Officials

**Official 1:**

**Affiliation:** Department of Dermatology, University Hospital Muenster, Muenster, Germany

**Name:** Annegret Kuhn, Prof. Dr.

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003240

- Term: Connective Tissue Diseases

- ID: D000001327

- Term: Autoimmune Diseases

- ID: D000007154

- Term: Immune System Diseases

- ID: D000012871

- Term: Skin Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M11175

- Name: Lupus Erythematosus, Cutaneous

- Relevance: HIGH

- As Found: Cutaneous Lupus Erythematosus

- ID: M11176

- Name: Lupus Erythematosus, Discoid

- Relevance: LOW

- As Found: Unknown

- ID: M11177

- Name: Lupus Erythematosus, Systemic

- Relevance: HIGH

- As Found: Lupus Erythematosus

- ID: M6464

- Name: Connective Tissue Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4629

- Name: Autoimmune Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T1683

- Name: Cutaneous Lupus Erythematosus

- Relevance: HIGH

- As Found: Cutaneous Lupus Erythematosus

### Condition Browse Module - Meshes

- ID: D000008180

- Term: Lupus Erythematosus, Systemic

- ID: D000008178

- Term: Lupus Erythematosus, Cutaneous

### Intervention Browse Module - Ancestors

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000003879

- Term: Dermatologic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: Derm

- Name: Dermatologic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M1834

- Name: Alitretinoin

- Relevance: HIGH

- As Found: Weaning From Mechanical Ventilation

- ID: M7074

- Name: Dermatologic Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000077556

- Term: Alitretinoin

### Misc Info Module

- Version Holder: 2024-05-24
