Safety and Efficacy of KRP203 in Subacute Cutaneous Lupus Erythematosus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will assess the safety and efficacy of KRP203 in clinically active subacute cutaneous lupus erythematosus patients, who have demonstrated inadequate response to standard treatment, such as antimalarials.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Multiple Dose Study Of PD-0360324 In Patients With Active Cutaneous Lupus Erythematosus

NCT01470313

Cutaneous Lupus Erythematosus

TERMINATED PHASE1

A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis

NCT04221477

Lupus Nephritis

ACTIVE_NOT_RECRUITING PHASE3

Proof of Concept Study of SAR443122 in Patients With Cutaneous Lupus Erythematosus

NCT04781816

Cutaneous Lupus Erythematosus

COMPLETED PHASE2

A Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Cutaneous Lupus Erythematosus (CLE)

NCT06980805

Subacute Cutaneous Lupus Erythematosus Chronic Cutaneous Lupus Erythematosus

RECRUITING PHASE2

A Study to Evaluate Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus (BEGIN)

NCT00539838

Systemic Lupus Erythematosus

TERMINATED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Subacute Cutaneous Lupus Erythematosus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

KRP203 - 1.2 mg

Group Type EXPERIMENTAL

KRP203 - 1.2mg

Intervention Type DRUG

Placebo to KRP203 - 1.2 mg

Group Type PLACEBO_COMPARATOR

Placebo to KRP203 - 1.2 mg

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

KRP203 - 1.2mg

Intervention Type DRUG

Placebo to KRP203 - 1.2 mg

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male and female patients,18 to 65 years of age inclusive, who have been defined as having SCLE based on the typical clinical picture and the characteristic histopathological features as described by Sontheimer et al. at least three months before study entry (screening)

Exclusion Criteria

1. Patients with preexisting nephritis, central nervous or pulmonary involvement or any major internal organ damage, either related or unrelated to lupus, which are deemed by the Investigator to be clinically significant. Patients having signs or symptoms of other autoimmune diseases such as systemic lupus erythematosus or Sjogren's syndrome are allowed to enter the study at the Investigator's discretion.
2. Patients who have been treated with:

* immunoglobulins and/or monoclonal antibodies within 6 months prior to randomization.
* rituximab, cyclophosphamide, or other immunosuppressive treatments with effects potentially lasting over 6 months, within 12 months prior to randomization.
* a medium or high dose (≥ 1 mg prednisone or equivalent per body weight kg) corticosteroid therapy in the last 8 weeks prior to randomization.
* antimalarial agents (hydroxychloroquine, chloroquine or quinacrine) in the last 6 weeks prior to randomization.
* biologic therapies, such as etanercept, within the last 4 weeks prior to randomization.
* any other immunosuppressive or immunomodulatory therapy such as methotrexate, azathioprine, cyclosporin A or mycophenolate, thalidomide, retinoids or dapsone in the last 4 weeks prior to randomization.
* total lymphoid irradiation or bone marrow transplantation.
3. Pregnant, planning to get pregnant, and/or lactating females or males planning to father a child within time period of the study or subsequent exclusionary period.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No