The purpose of this study is to evaluate the safety and efficacy of repeated intravenous infusions of the study drug BT063 in patients with Systemic Lupus Erythematosus (SLE) compared with people who receive a placebo.

Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus

Systemic Lupus Erythematosus

Study 990 is a Phase IIa, proof-of-concept study of BT063 in subjects with SLE. This study is divided into 2 parts. After Part I an interim analysis will be performed. Each Part will enrol 18 subjects. Subjects will be randomly assigned to receive BT063 or Placebo 8 times over 12 weeks and will be followed for 4 months after their last dose.

BT063

Placebo

A Prospective, Double-blind, Randomized, Placebo-controlled, Repeated Dose, Multicentre Phase IIa Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus

Number of Participants with Adverse Events (Including SAEs and AEs leading to discontinuation) from Baseline through End of Trial Visit (Week 14)

Number of Participants with changes in vital signs, ECGs, Safety laboratory parameters (full blood count including white differential count, clinical chemistry, thyroid hormones, urinalysis, and faecal occult blood test), Development of anti-drug antibodies against BT063 (anti-BT063), Immunological status of potential viral and bacterial infections (HBV, HCV, HIV, tetanus, diphtheria tuberculosis), EBV / CMV Serology, Premature withdrawals.

Number of Participants with 50% improvement of swollen/tender joints. A total of 66/68 joints was assessed for the swollen/tender joint count. A joint that is normal (no tenderness or swelling), without signs of inflammation will be graded as 0. A joint with tenderness will be graded as 1 for tender joint count and a joint with swelling will be graded as 1 for swollen joint count. Joints suspected or known to have ischemic osteonecrosis are not to be taken into consideration. Higher scores indicate more disease activity.

Number of Participants with 50% improvement in Cutaneous Lupus Erythematosus Disease Area and Sensitivity Index (CLASI) Activity score. The CLASI is an assessment over 13 body regions (scalp, ears, nose - including malar area, rest of the face, V-area neck - frontal, post. neck & shoulders, chest, abdomen, back and buttocks, arms, hands, legs, feet) and consists of 2 scores: total activity score and total damage score. Only the activity score was used in this study.

The minimum score possible on this scale is 0 and the maximum score is 70. The higher scores mean a worse outcome.

Percent changes in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) scores from baseline SLEDAI-2K score.

The SLEDAI-2K is a global index that measures SLE disease activity. It includes 24 items for the 9 organs/systems. Scores range from 0 to 105; a score of 6 is considered clinically important. The index measures disease activity within the last 10 days. Higher scores mean worse outcome. Negative percent change means reduced disease activity.

50 mg BT063 administered by intravenous (IV) infusion 8 times

Placebo administered by IV infusion 8 times

Study Site 37505

Study Site 37501

Study Site 37502

Study Site 37503

Study Site 37504

Study Site 99501

Study Site 99502

Study Site 48003

Study Site 48004

Study Site 48002

Study Site 48001

Study Site 38101

Study Site 38103

Study Site 38102

50 mg BT063 administered by intravenous (IV) infusion 8 times

BT063: Repeated IV infusions over 12 weeks (at weeks 0, 1, 2, 4, 6, 8, 10, 12)

BT063 50 mg

100 mg BT063 administered by intravenous (IV) infusion 8 times

BT063: Repeated IV infusions over 12 weeks (at weeks 0, 1, 2, 4, 6, 8, 10, 12)

BT063 100 mg

Placebo administered by IV infusion 8 times

Placebo: Repeated IV infusions over 12 weeks (at weeks 0, 1, 2, 4, 6, 8, 10, 12)

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Dr. Peter Röttgen

Subjects with TEAEs

Subjects with TEAEs leading to early termination

Subjects with treatment-emergent SAEs

Subjects with drug-related TEAEs

Subjects with severe TEAEs

Subjects with TEAEs leading to death

Number of Participants With Adverse Events

Number of Participants With Changes of Safety Parameters

50% improvement in swollen joints at week 14

50% improvement in swollen joints at week 28

50% improvement in tender joints at week 14

50% improvement in tender joints at week 28

Intension-To-Treat Set included 36 subjects (12 of each Group). At week 14, 1 subject in Placebo Group had no end of Treatment result; at week 28, 1 subject of 50 mg and 2 subjects of Placebo had no results. The efficacy outcome was based on observed cases.

Number of Participants With Improvements of Joints

50% improvement in CLASI Activity score at week 14

50% improvement in CLASI Activity score at week 28

Number of Participants with 50% improvement in Cutaneous Lupus Erythematosus Disease Area and Sensitivity Index (CLASI) Activity score. The CLASI is an assessment over 13 body regions (scalp, ears, nose - including malar area, rest of the face, V-area neck - frontal, post. neck \& shoulders, chest, abdomen, back and buttocks, arms, hands, legs, feet) and consists of 2 scores: total activity score and total damage score. Only the activity score was used in this study.

The minimum score possible on this scale is 0 and the maximum score is 70. The higher scores mean a worse outcome.

Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?