Trial Outcomes & Findings for A Long-Term Study of the Safety and Tolerability of Repeated Administration of CEP-33457 in Participants With Systemic Lupus Erythematosus (NCT NCT01240694)
NCT ID: NCT01240694
Last Updated: 2022-12-30
Results Overview
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs included clinically significant vitals, labs, and physical examination findings. Serious adverse events (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
136 participants
Primary outcome timeframe
Baseline up to Week 72
Results posted on
2022-12-30
Participant Flow
Participant milestones
| Measure |
CEP-33457
Participants received 200 micrograms (mcg) of CEP-33457 subcutaneously (SC) every 4 weeks for a maximum of 17 doses (64 weeks).
|
|---|---|
|
Overall Study
STARTED
|
136
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
136
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
135
|
Reasons for withdrawal
| Measure |
CEP-33457
Participants received 200 micrograms (mcg) of CEP-33457 subcutaneously (SC) every 4 weeks for a maximum of 17 doses (64 weeks).
|
|---|---|
|
Overall Study
Adverse Event
|
9
|
|
Overall Study
Lack of Efficacy
|
6
|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Other than specified
|
3
|
|
Overall Study
Withdrawn due to early study termination
|
107
|
Baseline Characteristics
A Long-Term Study of the Safety and Tolerability of Repeated Administration of CEP-33457 in Participants With Systemic Lupus Erythematosus
Baseline characteristics by cohort
| Measure |
CEP-33457
n=136 Participants
Participants received 200 mcg of CEP-33457 SC every 4 weeks for a maximum of 17 doses (64 weeks).
|
|---|---|
|
Age, Continuous
|
40.6 years
STANDARD_DEVIATION 11.44 • n=5 Participants
|
|
Sex: Female, Male
Female
|
124 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
120 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
101 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 72Population: Safety analysis set included all enrolled participants who took at least 1 dose of study drug.
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs included clinically significant vitals, labs, and physical examination findings. Serious adverse events (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Outcome measures
| Measure |
CEP-33457
n=136 Participants
Participants received 200 mcg of CEP-33457 SC every 4 weeks for a maximum of 17 doses (64 weeks).
|
|---|---|
|
Number of Participants With Adverse Events (AEs)
|
117 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 72Population: Safety analysis set included all enrolled participants who took at least 1 dose of study drug.
Any concomitant therapy or medication taken while the participant received study drug.
Outcome measures
| Measure |
CEP-33457
n=136 Participants
Participants received 200 mcg of CEP-33457 SC every 4 weeks for a maximum of 17 doses (64 weeks).
|
|---|---|
|
Number of Participants Who Received Concomitant Medications
|
136 Participants
|
SECONDARY outcome
Timeframe: Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72Population: Intent-to-treat (ITT) analysis set included all enrolled participants who took at least 1 dose of study drug.
An SRI response was defined as a reduction from baseline in SLE Disease Activity Index 2000 (SLEDAI-2K) score of ≥4 points, no worsening in Physician Global Assessment (PhGA), no new British Isles Lupus Assessment Group (BILAG) A body system score, and ≤1 new BILAG B body system score from baseline. SLEDAI 2K includes 24 weighted clinical and laboratory variables. Total score = 0 to 105. A score of 6 to 10 = moderate disease activity, and a reduction of \>3 points = improvement. PhGA was completed by physician using a visual analog scale (VAS) from 0=none to 3=severe. A change of \>0.3 points = worsening. BILAG includes 97 clinical and laboratory items. Each organ system is assigned a score displayed as a grade from A to E: A=very active disease; B=participant needs increase in treatment for moderately active disease; C=stable or mild disease; D=previous organ involvement but no current disease activity; and E=no current disease activity and organ system has never been involved.
Outcome measures
| Measure |
CEP-33457
n=136 Participants
Participants received 200 mcg of CEP-33457 SC every 4 weeks for a maximum of 17 doses (64 weeks).
|
|---|---|
|
Number of Participants Achieving a Clinical Response Using the Systemic Lupus Erythematosus (SLE) Responder Index (SRI)
Week 4
|
10 Participants
|
|
Number of Participants Achieving a Clinical Response Using the Systemic Lupus Erythematosus (SLE) Responder Index (SRI)
Week 8
|
18 Participants
|
|
Number of Participants Achieving a Clinical Response Using the Systemic Lupus Erythematosus (SLE) Responder Index (SRI)
Week 12
|
19 Participants
|
|
Number of Participants Achieving a Clinical Response Using the Systemic Lupus Erythematosus (SLE) Responder Index (SRI)
Week 16
|
19 Participants
|
|
Number of Participants Achieving a Clinical Response Using the Systemic Lupus Erythematosus (SLE) Responder Index (SRI)
Week 20
|
21 Participants
|
|
Number of Participants Achieving a Clinical Response Using the Systemic Lupus Erythematosus (SLE) Responder Index (SRI)
Week 24
|
18 Participants
|
|
Number of Participants Achieving a Clinical Response Using the Systemic Lupus Erythematosus (SLE) Responder Index (SRI)
Week 28
|
17 Participants
|
|
Number of Participants Achieving a Clinical Response Using the Systemic Lupus Erythematosus (SLE) Responder Index (SRI)
Week 32
|
11 Participants
|
|
Number of Participants Achieving a Clinical Response Using the Systemic Lupus Erythematosus (SLE) Responder Index (SRI)
Week 36
|
12 Participants
|
|
Number of Participants Achieving a Clinical Response Using the Systemic Lupus Erythematosus (SLE) Responder Index (SRI)
Week 40
|
10 Participants
|
|
Number of Participants Achieving a Clinical Response Using the Systemic Lupus Erythematosus (SLE) Responder Index (SRI)
Week 44
|
6 Participants
|
|
Number of Participants Achieving a Clinical Response Using the Systemic Lupus Erythematosus (SLE) Responder Index (SRI)
Week 48
|
5 Participants
|
|
Number of Participants Achieving a Clinical Response Using the Systemic Lupus Erythematosus (SLE) Responder Index (SRI)
Week 52
|
5 Participants
|
|
Number of Participants Achieving a Clinical Response Using the Systemic Lupus Erythematosus (SLE) Responder Index (SRI)
Week 56
|
6 Participants
|
|
Number of Participants Achieving a Clinical Response Using the Systemic Lupus Erythematosus (SLE) Responder Index (SRI)
Week 60
|
2 Participants
|
|
Number of Participants Achieving a Clinical Response Using the Systemic Lupus Erythematosus (SLE) Responder Index (SRI)
Week 64
|
1 Participants
|
|
Number of Participants Achieving a Clinical Response Using the Systemic Lupus Erythematosus (SLE) Responder Index (SRI)
Week 68
|
0 Participants
|
|
Number of Participants Achieving a Clinical Response Using the Systemic Lupus Erythematosus (SLE) Responder Index (SRI)
Week 72
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64 and Final Assessment (or Early Termination [up to Week 72])Population: ITT analysis set included all enrolled participants who took at least 1 dose of study drug. Here, 'number analyzed' signifies participants evaluable at specified timepoint.
The SLEDAI-2K is a validated objective measure that assesses disease activity within the last 28 days before completion of the index. It is a global index and includes 24 weighted clinical and laboratory variables. The total score (sum of all 24 scores) ranges from 0 to 105, with higher scores representing increased disease activity.
Outcome measures
| Measure |
CEP-33457
n=136 Participants
Participants received 200 mcg of CEP-33457 SC every 4 weeks for a maximum of 17 doses (64 weeks).
|
|---|---|
|
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Total Score
Change at Week 4
|
-0.4 units on a scale
Standard Deviation 2.48
|
|
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Total Score
Change at Week 8
|
-0.9 units on a scale
Standard Deviation 2.36
|
|
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Total Score
Change at Week 12
|
-0.9 units on a scale
Standard Deviation 2.71
|
|
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Total Score
Change at Week 16
|
-0.7 units on a scale
Standard Deviation 2.74
|
|
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Total Score
Change at Week 20
|
-1.3 units on a scale
Standard Deviation 3.10
|
|
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Total Score
Change at Week 24
|
-1.5 units on a scale
Standard Deviation 3.40
|
|
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Total Score
Change at Week 28
|
-2.0 units on a scale
Standard Deviation 3.80
|
|
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Total Score
Change at Week 32
|
-1.9 units on a scale
Standard Deviation 3.48
|
|
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Total Score
Change at Week 36
|
-2.1 units on a scale
Standard Deviation 3.39
|
|
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Total Score
Change at Week 40
|
-1.9 units on a scale
Standard Deviation 3.34
|
|
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Total Score
Change at Week 44
|
-2.3 units on a scale
Standard Deviation 3.84
|
|
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Total Score
Change at Week 48
|
-2.2 units on a scale
Standard Deviation 3.86
|
|
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Total Score
Change at Week 52
|
-3.0 units on a scale
Standard Deviation 3.94
|
|
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Total Score
Change at Week 56
|
-3.6 units on a scale
Standard Deviation 4.41
|
|
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Total Score
Change at Week 60
|
-2.3 units on a scale
Standard Deviation 5.52
|
|
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Total Score
Change at Week 64
|
-3.3 units on a scale
Standard Deviation 6.50
|
|
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Total Score
Change at Final Assessment (or Early Termination [up to Week 72])
|
-0.9 units on a scale
Standard Deviation 3.62
|
SECONDARY outcome
Timeframe: Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72Population: ITT analysis set included all enrolled participants who took at least 1 dose of study drug.
The BILAG-2004 is a validated objective and subjective global measure of the SLE disease activity, based on the physician's intention to treat, and refers to disease activity within the last 4 weeks before completion of the index. It includes 97 clinical and laboratory components to evaluate SLE disease activity in 9 different body systems (constitutional, mucocutaneous, neuropsychiatric, musculoskeletal, cardiorespiratory, gastrointestinal, ophthalmic, renal, and hematological). Each body system is assigned a score displayed as a grade from A to E, as follows: A=very active disease; B=participant needs increase in treatment for moderately active disease; C=stab1e or mild disease; D=previous system involvement but no current disease activity; and E=no current disease activity and the body system has never been involved. BILAG 2004 response was defined as no new BILAG A body system score and no more than 1 new BILAG B body system score from baseline.
Outcome measures
| Measure |
CEP-33457
n=136 Participants
Participants received 200 mcg of CEP-33457 SC every 4 weeks for a maximum of 17 doses (64 weeks).
|
|---|---|
|
Number of Participants With British Isles Lupus Assessment Group 2004 (BILAG-2004) Response
Week 4
|
126 Participants
|
|
Number of Participants With British Isles Lupus Assessment Group 2004 (BILAG-2004) Response
Week 8
|
118 Participants
|
|
Number of Participants With British Isles Lupus Assessment Group 2004 (BILAG-2004) Response
Week 12
|
111 Participants
|
|
Number of Participants With British Isles Lupus Assessment Group 2004 (BILAG-2004) Response
Week 16
|
110 Participants
|
|
Number of Participants With British Isles Lupus Assessment Group 2004 (BILAG-2004) Response
Week 20
|
88 Participants
|
|
Number of Participants With British Isles Lupus Assessment Group 2004 (BILAG-2004) Response
Week 24
|
56 Participants
|
|
Number of Participants With British Isles Lupus Assessment Group 2004 (BILAG-2004) Response
Week 28
|
47 Participants
|
|
Number of Participants With British Isles Lupus Assessment Group 2004 (BILAG-2004) Response
Week 32
|
34 Participants
|
|
Number of Participants With British Isles Lupus Assessment Group 2004 (BILAG-2004) Response
Week 36
|
30 Participants
|
|
Number of Participants With British Isles Lupus Assessment Group 2004 (BILAG-2004) Response
Week 40
|
28 Participants
|
|
Number of Participants With British Isles Lupus Assessment Group 2004 (BILAG-2004) Response
Week 44
|
22 Participants
|
|
Number of Participants With British Isles Lupus Assessment Group 2004 (BILAG-2004) Response
Week 48
|
19 Participants
|
|
Number of Participants With British Isles Lupus Assessment Group 2004 (BILAG-2004) Response
Week 52
|
15 Participants
|
|
Number of Participants With British Isles Lupus Assessment Group 2004 (BILAG-2004) Response
Week 56
|
12 Participants
|
|
Number of Participants With British Isles Lupus Assessment Group 2004 (BILAG-2004) Response
Week 60
|
7 Participants
|
|
Number of Participants With British Isles Lupus Assessment Group 2004 (BILAG-2004) Response
Week 64
|
3 Participants
|
|
Number of Participants With British Isles Lupus Assessment Group 2004 (BILAG-2004) Response
Week 68
|
0 Participants
|
|
Number of Participants With British Isles Lupus Assessment Group 2004 (BILAG-2004) Response
Week 72
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72Population: ITT analysis set included all enrolled participants who took at least 1 dose of study drug.
The PhGA was completed by the physician using a 3-inch visual analog scale (VAS) labeled from 0=none to 3=severe. A change of greater than 0.3 point on the VAS indicates worsening. The number of participants showing no worsening are presented.
Outcome measures
| Measure |
CEP-33457
n=136 Participants
Participants received 200 mcg of CEP-33457 SC every 4 weeks for a maximum of 17 doses (64 weeks).
|
|---|---|
|
Number of Participants Showing No Worsening on Physician's Global Assessment (PhGA) Scale
Week 4
|
113 Participants
|
|
Number of Participants Showing No Worsening on Physician's Global Assessment (PhGA) Scale
Week 8
|
111 Participants
|
|
Number of Participants Showing No Worsening on Physician's Global Assessment (PhGA) Scale
Week 12
|
105 Participants
|
|
Number of Participants Showing No Worsening on Physician's Global Assessment (PhGA) Scale
Week 16
|
100 Participants
|
|
Number of Participants Showing No Worsening on Physician's Global Assessment (PhGA) Scale
Week 20
|
76 Participants
|
|
Number of Participants Showing No Worsening on Physician's Global Assessment (PhGA) Scale
Week 24
|
48 Participants
|
|
Number of Participants Showing No Worsening on Physician's Global Assessment (PhGA) Scale
Week 28
|
41 Participants
|
|
Number of Participants Showing No Worsening on Physician's Global Assessment (PhGA) Scale
Week 32
|
34 Participants
|
|
Number of Participants Showing No Worsening on Physician's Global Assessment (PhGA) Scale
Week 36
|
28 Participants
|
|
Number of Participants Showing No Worsening on Physician's Global Assessment (PhGA) Scale
Week 40
|
25 Participants
|
|
Number of Participants Showing No Worsening on Physician's Global Assessment (PhGA) Scale
Week 44
|
20 Participants
|
|
Number of Participants Showing No Worsening on Physician's Global Assessment (PhGA) Scale
Week 48
|
19 Participants
|
|
Number of Participants Showing No Worsening on Physician's Global Assessment (PhGA) Scale
Week 52
|
15 Participants
|
|
Number of Participants Showing No Worsening on Physician's Global Assessment (PhGA) Scale
Week 56
|
10 Participants
|
|
Number of Participants Showing No Worsening on Physician's Global Assessment (PhGA) Scale
Week 60
|
8 Participants
|
|
Number of Participants Showing No Worsening on Physician's Global Assessment (PhGA) Scale
Week 64
|
3 Participants
|
|
Number of Participants Showing No Worsening on Physician's Global Assessment (PhGA) Scale
Week 68
|
0 Participants
|
|
Number of Participants Showing No Worsening on Physician's Global Assessment (PhGA) Scale
Week 72
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 12, 24, 36, 48, 60, and 72Population: ITT analysis set included all enrolled participants who took at least 1 dose of study drug.
The PtGA was completed by the participant, using a 3-inch VAS labeled from 0=none to 3=severe. A change of greater than 0.3 point on the VAS indicated worsening. The number of participants showing no worsening are presented.
Outcome measures
| Measure |
CEP-33457
n=136 Participants
Participants received 200 mcg of CEP-33457 SC every 4 weeks for a maximum of 17 doses (64 weeks).
|
|---|---|
|
Number of Participants Showing No Worsening on Patient's Global Assessment (PtGA) Scale
Week 12
|
90 Participants
|
|
Number of Participants Showing No Worsening on Patient's Global Assessment (PtGA) Scale
Week 24
|
43 Participants
|
|
Number of Participants Showing No Worsening on Patient's Global Assessment (PtGA) Scale
Week 36
|
23 Participants
|
|
Number of Participants Showing No Worsening on Patient's Global Assessment (PtGA) Scale
Week 48
|
17 Participants
|
|
Number of Participants Showing No Worsening on Patient's Global Assessment (PtGA) Scale
Week 60
|
6 Participants
|
|
Number of Participants Showing No Worsening on Patient's Global Assessment (PtGA) Scale
Week 72
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 24, 36, 48, 60 and final assessment (or early termination [up to Week 72])Population: ITT analysis set included all enrolled participants who took at least 1 dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable for specified category.
The SF-36 questionnaire has 36 questions composing the scale that represent 8 domains: 1) physical functioning, 2) physical role functioning, 3) bodily pain, 4) general health, 5) vitality, 6) social functioning, 7) emotional role functioning, and 8) mental health. All domains are scored on a scale from 0 (worst) to 100 (best), with higher scores representing the best possible health state. Change from baseline scores in the following individual standardized domains: Bodily pain, physical functioning, social functioning and vitality were presented.
Outcome measures
| Measure |
CEP-33457
n=134 Participants
Participants received 200 mcg of CEP-33457 SC every 4 weeks for a maximum of 17 doses (64 weeks).
|
|---|---|
|
Change From Baseline in Short-Form 36 (SF-36) Domain Scores
Bodily pain: Change at Week 12
|
2.8 units on a scale
Standard Deviation 16.43
|
|
Change From Baseline in Short-Form 36 (SF-36) Domain Scores
Bodily pain: Change at Week 24
|
1.5 units on a scale
Standard Deviation 20.68
|
|
Change From Baseline in Short-Form 36 (SF-36) Domain Scores
Bodily pain: Change at Week 36
|
5.5 units on a scale
Standard Deviation 23.09
|
|
Change From Baseline in Short-Form 36 (SF-36) Domain Scores
Bodily pain: Change at Week 48
|
8.8 units on a scale
Standard Deviation 16.18
|
|
Change From Baseline in Short-Form 36 (SF-36) Domain Scores
Bodily pain: Change at Week 60
|
9.0 units on a scale
Standard Deviation 28.59
|
|
Change From Baseline in Short-Form 36 (SF-36) Domain Scores
Bodily pain: Change at Final Assessment (or Early Termination [up to Week 72])
|
2.7 units on a scale
Standard Deviation 20.26
|
|
Change From Baseline in Short-Form 36 (SF-36) Domain Scores
Physical functioning: Change at Week 12
|
1.7 units on a scale
Standard Deviation 12.28
|
|
Change From Baseline in Short-Form 36 (SF-36) Domain Scores
Physical functioning: Change at Week 24
|
-0.4 units on a scale
Standard Deviation 15.57
|
|
Change From Baseline in Short-Form 36 (SF-36) Domain Scores
Physical functioning: Change at Week 36
|
-0.5 units on a scale
Standard Deviation 17.20
|
|
Change From Baseline in Short-Form 36 (SF-36) Domain Scores
Physical functioning: Change at Week 48
|
3.0 units on a scale
Standard Deviation 14.36
|
|
Change From Baseline in Short-Form 36 (SF-36) Domain Scores
Physical functioning: Change at Week 60
|
4.4 units on a scale
Standard Deviation 15.45
|
|
Change From Baseline in Short-Form 36 (SF-36) Domain Scores
Physical functioning: Change at Final Assessment (or Early Termination [up to Week 72])
|
1.1 units on a scale
Standard Deviation 17.04
|
|
Change From Baseline in Short-Form 36 (SF-36) Domain Scores
Social functioning: Change at Week 12
|
0.7 units on a scale
Standard Deviation 15.18
|
|
Change From Baseline in Short-Form 36 (SF-36) Domain Scores
Social functioning: Change at Week 24
|
3.6 units on a scale
Standard Deviation 19.43
|
|
Change From Baseline in Short-Form 36 (SF-36) Domain Scores
Social functioning: Change at Week 36
|
2.3 units on a scale
Standard Deviation 21.87
|
|
Change From Baseline in Short-Form 36 (SF-36) Domain Scores
Social functioning: Change at Week 48
|
-0.6 units on a scale
Standard Deviation 22.75
|
|
Change From Baseline in Short-Form 36 (SF-36) Domain Scores
Social functioning: Change at Week 60
|
7.8 units on a scale
Standard Deviation 21.06
|
|
Change From Baseline in Short-Form 36 (SF-36) Domain Scores
Social functioning: Change at Final Assessment (or Early Termination [up to Week 72])
|
-0.1 units on a scale
Standard Deviation 20.56
|
|
Change From Baseline in Short-Form 36 (SF-36) Domain Scores
Vitality: Change at Week 12
|
3.4 units on a scale
Standard Deviation 15.28
|
|
Change From Baseline in Short-Form 36 (SF-36) Domain Scores
Vitality: Change at Week 24
|
2.1 units on a scale
Standard Deviation 18.04
|
|
Change From Baseline in Short-Form 36 (SF-36) Domain Scores
Vitality: Change at Week 36
|
3.9 units on a scale
Standard Deviation 19.03
|
|
Change From Baseline in Short-Form 36 (SF-36) Domain Scores
Vitality: Change at Week 48
|
4.7 units on a scale
Standard Deviation 17.78
|
|
Change From Baseline in Short-Form 36 (SF-36) Domain Scores
Vitality: Change at Week 60
|
7.0 units on a scale
Standard Deviation 23.25
|
|
Change From Baseline in Short-Form 36 (SF-36) Domain Scores
Vitality: Change at Final Assessment (or Early Termination [up to Week 72])
|
2.6 units on a scale
Standard Deviation 15.94
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 24, 36, 48, 60 and final assessment (or early termination [up to Week 72])Population: ITT analysis set included all enrolled participants who took at least 1 dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable at specified timepoint.
Anti-UI RNP Ab was measured from blood serum collected at specified time points.
Outcome measures
| Measure |
CEP-33457
n=132 Participants
Participants received 200 mcg of CEP-33457 SC every 4 weeks for a maximum of 17 doses (64 weeks).
|
|---|---|
|
Change From Baseline in the Biomarker: Anti-U1 Ribonucleoprotein Antibody (Anti-UI RNP Ab)
Change at Week 12
|
193.0 units (U)/milliliter (mL)
Standard Deviation 505.20
|
|
Change From Baseline in the Biomarker: Anti-U1 Ribonucleoprotein Antibody (Anti-UI RNP Ab)
Change at Week 24
|
313.6 units (U)/milliliter (mL)
Standard Deviation 642.69
|
|
Change From Baseline in the Biomarker: Anti-U1 Ribonucleoprotein Antibody (Anti-UI RNP Ab)
Change at Week 36
|
199.2 units (U)/milliliter (mL)
Standard Deviation 497.79
|
|
Change From Baseline in the Biomarker: Anti-U1 Ribonucleoprotein Antibody (Anti-UI RNP Ab)
Change at Week 48
|
327.7 units (U)/milliliter (mL)
Standard Deviation 643.54
|
|
Change From Baseline in the Biomarker: Anti-U1 Ribonucleoprotein Antibody (Anti-UI RNP Ab)
Change at Week 60
|
480.1 units (U)/milliliter (mL)
Standard Deviation 723.53
|
|
Change From Baseline in the Biomarker: Anti-U1 Ribonucleoprotein Antibody (Anti-UI RNP Ab)
Change at Final Assessment (or Early Termination [up to Week 72])
|
154.7 units (U)/milliliter (mL)
Standard Deviation 470.23
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 24, 36, 48, 60, and Final Assessment (or Early Termination [up to Week 72])Population: ITT analysis set included all enrolled participants who took at least 1 dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable at specified timepoint.
CRP was measured from blood serum samples at specified time points.
Outcome measures
| Measure |
CEP-33457
n=132 Participants
Participants received 200 mcg of CEP-33457 SC every 4 weeks for a maximum of 17 doses (64 weeks).
|
|---|---|
|
Change From Baseline in the Biomarker: C-Reactive Protein (CRP)
Change at Week 12
|
0 milligrams (mg)/deciliter (dL)
Standard Deviation 0.68
|
|
Change From Baseline in the Biomarker: C-Reactive Protein (CRP)
Change at Week 24
|
0 milligrams (mg)/deciliter (dL)
Standard Deviation 0.48
|
|
Change From Baseline in the Biomarker: C-Reactive Protein (CRP)
Change at Week 36
|
-0.1 milligrams (mg)/deciliter (dL)
Standard Deviation 0.41
|
|
Change From Baseline in the Biomarker: C-Reactive Protein (CRP)
Change at Week 48
|
0 milligrams (mg)/deciliter (dL)
Standard Deviation 0.46
|
|
Change From Baseline in the Biomarker: C-Reactive Protein (CRP)
Change at Week 60
|
-0.1 milligrams (mg)/deciliter (dL)
Standard Deviation 0.30
|
|
Change From Baseline in the Biomarker: C-Reactive Protein (CRP)
Change at Final Assessment (or Early Termination [up to Week 72])
|
0 milligrams (mg)/deciliter (dL)
Standard Deviation 0.82
|
SECONDARY outcome
Timeframe: Week 12, 24, 36, 48, 60, and Final Assessment (or Early Termination [up to Week 72])Population: ITT analysis set included all enrolled participants who took at least 1 dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable at specified timepoint.
Anti-nuclear antibodies (ANA) were measured from blood serum samples at specified time points.
Outcome measures
| Measure |
CEP-33457
n=126 Participants
Participants received 200 mcg of CEP-33457 SC every 4 weeks for a maximum of 17 doses (64 weeks).
|
|---|---|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Final Assessment (or Early Termination [up to Week 72]) · >=1:1280
|
30 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Week 12 · None detected
|
0 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Week 12 · <1:40
|
0 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Week 12 · 1:40
|
16 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Week 12 · 1:80
|
17 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Week 12 · 1:160
|
20 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Week 12 · 1:320
|
30 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Week 12 · 1:640
|
7 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Week 12 · 1:1280
|
0 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Week 12 · >=1:1280
|
22 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Week 24 · None detected
|
0 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Week 24 · <1:40
|
0 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Week 24 · 1:40
|
3 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Week 24 · 1:80
|
11 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Week 24 · 1:160
|
12 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Week 24 · 1:320
|
11 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Week 24 · 1:640
|
4 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Week 24 · 1:1280
|
0 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Week 24 · >=1:1280
|
16 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Week 36 · None detected
|
0 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Week 36 · <1:40
|
0 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Week 36 · 1:40
|
5 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Week 36 · 1:80
|
6 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Week 36 · 1:160
|
7 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Week 36 · 1:320
|
4 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Week 36 · 1:640
|
2 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Week 36 · 1:1280
|
0 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Week 36 · >=1:1280
|
6 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Week 48 · None detected
|
0 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Week 48 · <1:40
|
0 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Week 48 · 1:40
|
4 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Week 48 · 1:80
|
4 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Week 48 · 1:160
|
3 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Week 48 · 1:320
|
2 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Week 48 · 1:640
|
2 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Week 48 · 1:1280
|
0 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Week 48 · >=1:1280
|
5 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Week 60 · None detected
|
0 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Week 60 · <1:40
|
0 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Week 60 · 1:40
|
1 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Week 60 · 1:80
|
2 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Week 60 · 1:160
|
2 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Week 60 · 1:320
|
1 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Week 60 · 1:640
|
1 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Week 60 · 1:1280
|
0 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Week 60 · >=1:1280
|
1 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Final Assessment (or Early Termination [up to Week 72]) · None detected
|
0 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Final Assessment (or Early Termination [up to Week 72]) · <1:40
|
0 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Final Assessment (or Early Termination [up to Week 72]) · 1:40
|
16 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Final Assessment (or Early Termination [up to Week 72]) · 1:80
|
16 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Final Assessment (or Early Termination [up to Week 72]) · 1:160
|
18 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Final Assessment (or Early Termination [up to Week 72]) · 1:320
|
28 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Final Assessment (or Early Termination [up to Week 72]) · 1:640
|
18 Participants
|
|
Number of Participants With Anti-nuclear Antibodies (ANA)
Final Assessment (or Early Termination [up to Week 72]) · 1:1280
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64 and Final Assessment (or Early Termination [up to Week 72])Population: ITT analysis set included all enrolled participants who took at least 1 dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable at specified timepoint.
The SELENA Flare Index divides flares into 2 categories: mild/moderate and severe. A severe flare would lead to early withdrawal. The number of participants with mild to moderate flare, severe flare, and no flare at each visit during the treatment period were reported.
Outcome measures
| Measure |
CEP-33457
n=135 Participants
Participants received 200 mcg of CEP-33457 SC every 4 weeks for a maximum of 17 doses (64 weeks).
|
|---|---|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Week 4 · Mild/moderate flare
|
15 Participants
|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Week 4 · Severe flare
|
1 Participants
|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Week 4 · No flare
|
114 Participants
|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Week 8 · Mild/moderate flare
|
13 Participants
|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Week 8 · Severe flare
|
0 Participants
|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Week 8 · No flare
|
109 Participants
|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Week 12 · Mild/moderate flare
|
21 Participants
|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Week 12 · Severe flare
|
0 Participants
|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Week 12 · No flare
|
97 Participants
|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Week 16 · Mild/moderate flare
|
14 Participants
|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Week 16 · Severe flare
|
0 Participants
|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Week 16 · No flare
|
99 Participants
|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Week 20 · Mild/moderate flare
|
9 Participants
|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Week 20 · Severe flare
|
0 Participants
|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Week 20 · No flare
|
82 Participants
|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Week 24 · Mild/moderate flare
|
8 Participants
|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Week 24 · Severe flare
|
0 Participants
|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Week 24 · No flare
|
51 Participants
|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Week 28 · Mild/moderate flare
|
8 Participants
|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Week 28 · Severe flare
|
0 Participants
|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Week 28 · No flare
|
39 Participants
|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Week 32 · Mild/moderate flare
|
5 Participants
|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Week 32 · Severe flare
|
0 Participants
|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Week 32 · No flare
|
32 Participants
|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Week 36 · Mild/moderate flare
|
4 Participants
|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Week 36 · Severe flare
|
0 Participants
|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Week 36 · No flare
|
28 Participants
|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Week 40 · Mild/moderate flare
|
4 Participants
|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Week 40 · Severe flare
|
0 Participants
|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Week 40 · No flare
|
25 Participants
|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Week 44 · Mild/moderate flare
|
4 Participants
|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Week 44 · Severe flare
|
0 Participants
|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Week 44 · No flare
|
21 Participants
|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Week 48 · Mild/moderate flare
|
2 Participants
|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Week 48 · Severe flare
|
0 Participants
|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Week 48 · No flare
|
19 Participants
|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Week 52 · Mild/moderate flare
|
2 Participants
|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Week 52 · Severe flare
|
0 Participants
|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Week 52 · No flare
|
15 Participants
|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Week 56 · Mild/moderate flare
|
3 Participants
|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Week 56 · Severe flare
|
0 Participants
|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Week 56 · No flare
|
10 Participants
|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Week 60 · Mild/moderate flare
|
2 Participants
|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Week 60 · Severe flare
|
0 Participants
|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Week 60 · No flare
|
6 Participants
|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Week 64 · Mild/moderate flare
|
1 Participants
|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Week 64 · Severe flare
|
0 Participants
|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Week 64 · No flare
|
3 Participants
|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Final Assessment (or Early Termination [up to Week 72]) · Mild/moderate flare
|
24 Participants
|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Final Assessment (or Early Termination [up to Week 72]) · Severe flare
|
4 Participants
|
|
Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index
Final Assessment (or Early Termination [up to Week 72]) · No flare
|
107 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 24, 48 and Final Assessment (or Early Termination [up to Week 72])Population: ITT analysis set included all enrolled participants who took at least 1 dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable at specified timepoint.
The SLICC/ACR damage index assesses specific comorbidities associated with SLE. It consists of 41 items and covers 12 body systems. Total damage scores were calculated using the 41 items. The total damage score ranges from 0 (no damage) to 47 (maximum disease damage severity) with higher scores indicating increasing disease damage severity.
Outcome measures
| Measure |
CEP-33457
n=133 Participants
Participants received 200 mcg of CEP-33457 SC every 4 weeks for a maximum of 17 doses (64 weeks).
|
|---|---|
|
Change From Baseline in Total Damage Score as Assessed by the Systemic Lupus International Collaborative Clinics/American College of Rheumatology (SLICC/ACR) Damage Index
Change at Week 24
|
0 units on a scale
Standard Deviation 0.42
|
|
Change From Baseline in Total Damage Score as Assessed by the Systemic Lupus International Collaborative Clinics/American College of Rheumatology (SLICC/ACR) Damage Index
Change at Week 48
|
-0.1 units on a scale
Standard Deviation 0.48
|
|
Change From Baseline in Total Damage Score as Assessed by the Systemic Lupus International Collaborative Clinics/American College of Rheumatology (SLICC/ACR) Damage Index
Change at Final Assessment (or Early Termination [up to Week 72])
|
-0.1 units on a scale
Standard Deviation 0.44
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64 and Final Assessment (or Early Termination [up to Week 72])Population: ITT analysis set included all enrolled participants who took at least 1 dose of study drug. Here 'number analyzed' signifies participants evaluable at specified timepoint.
Remission of disease was defined as a reduction of SLEDAI-2K score to 0. The SLEDAI-2K is a validated objective measure that assesses disease activity within the last 28 days before completion of the index. It is a global index and includes 24 weighted clinical and laboratory variables. The total score (sum of all 24 scores) ranges from 0 to 105, with higher scores representing increased disease activity.
Outcome measures
| Measure |
CEP-33457
n=136 Participants
Participants received 200 mcg of CEP-33457 SC every 4 weeks for a maximum of 17 doses (64 weeks).
|
|---|---|
|
Number of Participants Achieving Remission of Disease
Week 4
|
8 Participants
|
|
Number of Participants Achieving Remission of Disease
Week 8
|
9 Participants
|
|
Number of Participants Achieving Remission of Disease
Week 12
|
11 Participants
|
|
Number of Participants Achieving Remission of Disease
Week 16
|
10 Participants
|
|
Number of Participants Achieving Remission of Disease
Week 20
|
10 Participants
|
|
Number of Participants Achieving Remission of Disease
Week 24
|
4 Participants
|
|
Number of Participants Achieving Remission of Disease
Week 28
|
2 Participants
|
|
Number of Participants Achieving Remission of Disease
Week 32
|
1 Participants
|
|
Number of Participants Achieving Remission of Disease
Week 36
|
1 Participants
|
|
Number of Participants Achieving Remission of Disease
Week 40
|
1 Participants
|
|
Number of Participants Achieving Remission of Disease
Week 44
|
1 Participants
|
|
Number of Participants Achieving Remission of Disease
Week 48
|
1 Participants
|
|
Number of Participants Achieving Remission of Disease
Week 52
|
1 Participants
|
|
Number of Participants Achieving Remission of Disease
Week 56
|
1 Participants
|
|
Number of Participants Achieving Remission of Disease
Week 60
|
0 Participants
|
|
Number of Participants Achieving Remission of Disease
Week 64
|
0 Participants
|
|
Number of Participants Achieving Remission of Disease
Final Assessment (or Early Termination [up to Week 72])
|
8 Participants
|
SECONDARY outcome
Timeframe: From Baseline up to Final Assessment (or Early Termination [up to Week 72])Population: ITT analysis set included all enrolled participants who took at least 1 dose of study drug.
Number of participants with change in steroid dose (prednisone equivalent/day) were reported. The change in steroid dose was evaluated to determine the number of participants taking a dose less than 7.5 mg of prednisone equivalent/day, a dose of 7.5 mg prednisone equivalent/day or more, and none per day.
Outcome measures
| Measure |
CEP-33457
n=136 Participants
Participants received 200 mcg of CEP-33457 SC every 4 weeks for a maximum of 17 doses (64 weeks).
|
|---|---|
|
Number of Participants With Change in Steroid Dose
<7.5 mg at Baseline to <7.5 mg at Final Assessment
|
37 Participants
|
|
Number of Participants With Change in Steroid Dose
<7.5 mg at Baseline to >=7.5 mg at Final Assessment
|
1 Participants
|
|
Number of Participants With Change in Steroid Dose
<7.5 mg at Baseline to None at Final Assessment
|
0 Participants
|
|
Number of Participants With Change in Steroid Dose
>=7.5 mg at Baseline to <7.5 mg at Final Assessment
|
5 Participants
|
|
Number of Participants With Change in Steroid Dose
>=7.5 mg at Baseline to >=7.5 mg at Final Assessment
|
49 Participants
|
|
Number of Participants With Change in Steroid Dose
>=7.5 mg at Baseline to None at Final Assessment
|
3 Participants
|
|
Number of Participants With Change in Steroid Dose
None at Baseline to <7.5 mg at Final Assessment
|
3 Participants
|
|
Number of Participants With Change in Steroid Dose
None at Baseline to >=7.5 mg at Final Assessment
|
2 Participants
|
|
Number of Participants With Change in Steroid Dose
None at Baseline to None at Final Assessment
|
36 Participants
|
SECONDARY outcome
Timeframe: Week 24, 48 and Final Assessment (or Early Termination [up to Week 72])Population: ITT analysis set included all enrolled participants who took at least 1 dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable at specified timepoint.
Immunogenicity was assessed by detection of the presence of specific anti-CEP-33457 antibodies in blood serum samples collected at the specified time points.
Outcome measures
| Measure |
CEP-33457
n=126 Participants
Participants received 200 mcg of CEP-33457 SC every 4 weeks for a maximum of 17 doses (64 weeks).
|
|---|---|
|
Number of Participants With Reactive and Non-Reactive Anti-CEP-33457 Antibodies
Week 24 · Reactive
|
4 Participants
|
|
Number of Participants With Reactive and Non-Reactive Anti-CEP-33457 Antibodies
Week 24 · Non-reactive
|
53 Participants
|
|
Number of Participants With Reactive and Non-Reactive Anti-CEP-33457 Antibodies
Week 48 · Reactive
|
1 Participants
|
|
Number of Participants With Reactive and Non-Reactive Anti-CEP-33457 Antibodies
Week 48 · Non-reactive
|
21 Participants
|
|
Number of Participants With Reactive and Non-Reactive Anti-CEP-33457 Antibodies
Final Assessment (or Early Termination [up to Week 72]) · Reactive
|
7 Participants
|
|
Number of Participants With Reactive and Non-Reactive Anti-CEP-33457 Antibodies
Final Assessment (or Early Termination [up to Week 72]) · Non-reactive
|
119 Participants
|
Adverse Events
CEP-33457
Serious events: 11 serious events
Other events: 89 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CEP-33457
n=136 participants at risk
Participants received 200 mcg of CEP-33457 SC every 4 weeks for a maximum of 17 doses (64 weeks).
|
|---|---|
|
Hepatobiliary disorders
Cholecystitis
|
0.74%
1/136 • Number of events 1 • Baseline up to Week 72
Safety analysis set included all enrolled participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Appendicitis
|
0.74%
1/136 • Number of events 1 • Baseline up to Week 72
Safety analysis set included all enrolled participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
1.5%
2/136 • Number of events 2 • Baseline up to Week 72
Safety analysis set included all enrolled participants who took at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.74%
1/136 • Number of events 1 • Baseline up to Week 72
Safety analysis set included all enrolled participants who took at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Injury
|
0.74%
1/136 • Number of events 1 • Baseline up to Week 72
Safety analysis set included all enrolled participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.74%
1/136 • Number of events 1 • Baseline up to Week 72
Safety analysis set included all enrolled participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
1.5%
2/136 • Number of events 2 • Baseline up to Week 72
Safety analysis set included all enrolled participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.74%
1/136 • Number of events 1 • Baseline up to Week 72
Safety analysis set included all enrolled participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Convulsion
|
0.74%
1/136 • Number of events 1 • Baseline up to Week 72
Safety analysis set included all enrolled participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Myelitis transverse
|
0.74%
1/136 • Number of events 1 • Baseline up to Week 72
Safety analysis set included all enrolled participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.74%
1/136 • Number of events 1 • Baseline up to Week 72
Safety analysis set included all enrolled participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.74%
1/136 • Number of events 1 • Baseline up to Week 72
Safety analysis set included all enrolled participants who took at least 1 dose of study drug.
|
Other adverse events
| Measure |
CEP-33457
n=136 participants at risk
Participants received 200 mcg of CEP-33457 SC every 4 weeks for a maximum of 17 doses (64 weeks).
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
7.4%
10/136 • Number of events 17 • Baseline up to Week 72
Safety analysis set included all enrolled participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
7.4%
10/136 • Number of events 12 • Baseline up to Week 72
Safety analysis set included all enrolled participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
5.9%
8/136 • Number of events 9 • Baseline up to Week 72
Safety analysis set included all enrolled participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
8.1%
11/136 • Number of events 13 • Baseline up to Week 72
Safety analysis set included all enrolled participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Sinusitis
|
7.4%
10/136 • Number of events 10 • Baseline up to Week 72
Safety analysis set included all enrolled participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
14.7%
20/136 • Number of events 25 • Baseline up to Week 72
Safety analysis set included all enrolled participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
7.4%
10/136 • Number of events 11 • Baseline up to Week 72
Safety analysis set included all enrolled participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.8%
12/136 • Number of events 15 • Baseline up to Week 72
Safety analysis set included all enrolled participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
11.0%
15/136 • Number of events 18 • Baseline up to Week 72
Safety analysis set included all enrolled participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.1%
7/136 • Number of events 10 • Baseline up to Week 72
Safety analysis set included all enrolled participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
13.2%
18/136 • Number of events 26 • Baseline up to Week 72
Safety analysis set included all enrolled participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
7.4%
10/136 • Number of events 16 • Baseline up to Week 72
Safety analysis set included all enrolled participants who took at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
5.1%
7/136 • Number of events 7 • Baseline up to Week 72
Safety analysis set included all enrolled participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.1%
7/136 • Number of events 7 • Baseline up to Week 72
Safety analysis set included all enrolled participants who took at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Systemic lupus erythematosus rash
|
11.8%
16/136 • Number of events 17 • Baseline up to Week 72
Safety analysis set included all enrolled participants who took at least 1 dose of study drug.
|
Additional Information
Director, Clinical Research
Teva Branded Pharmaceutical Products R&D, Inc.
Phone: 1-888-483-8279
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
- Publication restrictions are in place
Restriction type: OTHER