A Long-Term Extension (LTE) Study Of Enpatoran In Cutaneous Manifestations Of Lupus With Or Without Systemic Disease [Elowen-LTE]

Phase 3Not Yet RecruitingNCT07840287

EMD Serono Research & Development Institute, Inc.404 enrolled

Overview

The purpose of this study is to evaluate the long-term safety and efficacy of orally administered enpatoran in participants with cutaneous manifestations of lupus erythematosus who have completed the Elowen-1 (MS504908\_0001) (NCT07332481) and Elowen-2 (MS504908\_0008) (NCT07355218) study treatment and to provide participants an opportunity to receive active treatment with enpatoran for up to 108 weeks in this open-label study. Study details include: Study Duration: 120 weeks. Treatment Duration: 108 weeks. Visit Frequency: Every 4 weeks (from Week 4 to Week 24) and every 12 weeks (from Week 36 to Week 120). Study Intervention: Enpatoran. Intervention Form: Film-coated tablet.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

404

Conditions

Systemic Lupus Erythematosus (SLE)Cutaneous Lupus Erythematosus (CLE)

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 76 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Are up to date according to local guidelines/ recommendations. Recombinant zoster vaccination is encouraged but not mandatory. 2. Are participants with active cutaneous manifestations of lupus erythematosus that have successfully completed the 24-week treatment of the Elowen-1 or Elowen-2 study, including the Week 24 end of treatment (EOT) visit. Exclusion Criteria: 1. Participants who experienced serious event(s) related to the study intervention during the Elowen-1 and Elowen-2 studies, an unstable medical condition, or any other reason, in the opinion of the Investigator that would preclude participation in this LTE study. 2. Other severe acute or chronic medical or psychiatric condition. Clinically significant ECG findings or laboratory abnormality that may increase the risk associated with LTE study participation or study intervention administration and, in the judgment of the Investigator, would make the participant inappropriate to participate in this LTE study. 3. Active clinically significant viral (including Severe Acute Respiratory Syndrome Coronavirus \[SARS CoV\] 2), bacterial (including active tuberculosis or untreated latent tuberculosis), parasitic, or fungal infection or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives. Vaginal candidiasis, onychomycosis, and genital or oral herpes simplex virus considered sufficiently controlled will not be exclusionary. Note: if sign/symptoms suggest any underlying infection (at Investigator discretion), a negative or normal test result must be provided and discussed with the Medical Monitor. • All participants who entered Elowen-1 and Elowen-2 studies with positive anti-hepatitis B core (HBc) antibody and/or anti hepatitis B surface (HBs) antibody with non-detectable hepatitis B virus (HBV) deoxyribonucleic acid (DNA) at Screening must provide a negative HBV DNA polymerase chain reaction (PCR) result. 4. Received LTE-prohibited medication during participation in Elowen 1 or Elowen-2 study or after Elowen-1 or Elowen-2 study Week 24/EOT visit (may require prior discussion with Medical Monitor). 5. Participation in any other investigational drug study after Elowen-1 or Elowen-2 study Week 24/EOT visit. 6. Withdrawn during participation in Elowen-1 or Elowen-2 study due to any of the predefined criteria for study intervention or study withdrawal. 7. Planned major elective medical or surgical procedure.

Outcomes

Primary Outcomes

Number of Participants With Treatment Emergent adverse events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESI)

Time frame: From current LTE study Day 1 to Week 120

Secondary Outcomes

Number of Participants With Abnormalities in Laboratory Parameters (greater than or equal to [>=] Grade 3)

Time frame: From current LTE study Day 1 to Week 120

Number of Participants With Abnormalities in Vital Signs

Time frame: From current LTE study Day 1 to Week 120

Number of Participants With Abnormalities in Electrocardiogram (ECG) Parameter

Time frame: From current LTE study Day 1 to Week 120

Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)-70 Response, Defined as >= 70 Percent (%) Decrease in CLASI-A Score From Elowen-1/Elowen-2 study Baseline

Elowen-1 (MS504908\_0001) (NCT07332481) / Elowen-2 (MS504908\_0008) (NCT07355218) study Baseline values will be used as a reference for calculation.

Time frame: Elowen-1/Elowen-2 study Baseline, current LTE study Week 108

Percentage of Participants With CLASI-50 Response, Defined as >= 50% Decrease in CLASI-A Score From Elowen-1/Elowen-2 study Baseline

Elowen-1/Elowen-2 study Baseline values will be used as a reference for calculation.

Time frame: Elowen-1/Elowen-2 study Baseline, current LTE study Week 108

Percentage of Participants With CLASI-A less than and equal to (<=) 3

CLASI-A assesses the signs of CLE disease activity including erythema, scale/hypertrophy, mucous membrane lesions, hair loss and alopecia. Scores range from 0 to 70 points for CLASI-A score. Mild, moderate, and severe disease corresponds with CLASI activity score ranges of 0 to 9, 10 to 20, and 21 to 70, respectively. Higher scores indicate more disease activity.

Time frame: From current LTE study Day 1 to Week 108

Change From Elowen-1/Elowen-2 Study Baseline in Worst Itch Numeric Rating Scale (NRS) Through LTE Week 108

The Worst Itch NRS is a self-rated single item scale designed for assessing worst itch in the past 7 days. The scale utilizes 11-point NRS, scored from 0 (No itch) to 10 (Worst imaginable itch). Elowen-1/Elowen-2 study Baseline values will be used a reference to calculate change.

Time frame: Elowen 1/Elowen-2 study Baseline, current LTE study Week 108

Percentage of Participants With Worst Itch Response Through LTE Week 108 Based on Elowen-1/Elowen-2 study Baseline

Elowen-1/Elowen-2 study Baseline values will be used as a reference for calculation.

Time frame: Elowen 1/Elowen-2 study Baseline, current LTE study Week 108

Percentage of Participants With CLA-IGA-R Other Morphological Characteristics (OMC) Score of 0 or 1 and at Least a 1-Point Reduction From Elowen 1/Elowen-2 study Baseline to LTE study Week 108

Elowen-1/Elowen-2 study Baseline values will be used as a reference for calculation.

Time frame: Elowen 1/Elowen-2 study Baseline, current LTE study Week 108

Percentage of Participants With British Isles Lupus Assessment Group Based Composite Lupus Assessment (BICLA) Response

A BICLA response is defined as British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) -improvement without worsening (A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and less than or equal to \[\<=\] 1 new B.); Here, score A ("Active"): Severely active disease; score B ("Beware"): Moderately active disease; score C ("Contentment"): Mild stable disease; score D ("Discount"): Inactive now but previously active; -no worsening in disease activity (no new BILAG 2004 A scores and \<= 1 new B score); -no worsening of total Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score from Baseline; -no significant deterioration (less than \[\<\] 10% worsening) in visual analog Physician's Global Assessment (PGA) and -no treatment failure i.e. protocol-prohibited medications as determined by Endpoint Adjudication Committee (EAC) or premature discontinuation from study treatment).

Time frame: Elowen 1/Elowen-2 study Baseline, current LTE study Week 108

Percentage of Participants With Mild/Moderate and Severe Safety of Estrogens in Systemic Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) Flare

Time frame: From current LTE study Baseline to Week 108

Time to First Severe SELENA-SLEDAI Flare

Median time to first severe SELENA-SLEDAI flare will be calculated.

Time frame: From current LTE study Baseline to Week 108

Percentage of Participants with BILAG Moderate to Severe Flares

Time frame: From current LTE study Baseline to Week 108

Time to First Moderate/Severe BILAG Flare

Median time to first moderate or severe BILAG Flare will be calculated.

Time frame: From current LTE study Baseline to Week 108

Percentage of Participants With Lupus Low Disease Activity State (LLDAS) Attainment

Time frame: From LTE study Day 1 to Week 108

Percentage of Participants With Sustained LLDAS

Time frame: From LTE study Day 1 to Week 108

Change in Prednisone-equivalent Corticosteroid (CS) Dose From Elowen-1/Elowen-2 Study Baseline to LTE Study Week 108

Elowen-1/Elowen-2 study Baseline values will be used as a reference for calculation.

Time frame: Elowen-1/Elowen-2 study Baseline, current LTE study Week 108

Percentage of Participants With CS Reduction of Daily Prednisone Equivalent Dose

Elowen-1/Elowen-2 study Day 1 values will be used as a reference for calculation.

Time frame: Elowen-1/Elowen-2 study Day 1, current LTE study Week 108

A Long-Term Extension (LTE) Study Of Enpatoran In Cutaneous Manifestations Of Lupus With Or Without Systemic Disease [Elowen-LTE]

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts