Trial Outcomes & Findings for ALPN-101 (Acazicolcept) in Systemic Lupus Erythematosus (NCT NCT04835441)
NCT ID: NCT04835441
Last Updated: 2025-08-15
Results Overview
COMPLETED
PHASE2
76 participants
Day 1 up to Safety follow-up (up to 28 weeks)
2025-08-15
Participant Flow
The study was conducted in participants with active systemic lupus erythematosus (SLE) aged 18 years and older.
Participant milestones
| Measure |
ALPN-101 (Acazicolcept)
Participants received a weight-based dose of 3 milligrams/kilogram (mg/kg) ALPN-101 once every 2 weeks (Q2W) up to 24 weeks.
|
Placebo
Participants received placebo matched to ALPN-101 up to 24 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
38
|
|
Overall Study
COMPLETED
|
33
|
32
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
| Measure |
ALPN-101 (Acazicolcept)
Participants received a weight-based dose of 3 milligrams/kilogram (mg/kg) ALPN-101 once every 2 weeks (Q2W) up to 24 weeks.
|
Placebo
Participants received placebo matched to ALPN-101 up to 24 weeks.
|
|---|---|---|
|
Overall Study
Physician Decision
|
4
|
4
|
|
Overall Study
Other
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
ALPN-101 (Acazicolcept) in Systemic Lupus Erythematosus
Baseline characteristics by cohort
| Measure |
ALPN-101 (Acazicolcept)
n=38 Participants
Participants received a weight-based dose of 3mg/kg ALPN-101 Q2W up to 24 weeks.
|
Placebo
n=38 Participants
Participants received placebo matched to ALPN-101 up to 24 weeks.
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.7 years
STANDARD_DEVIATION 11.20 • n=5 Participants
|
47.8 years
STANDARD_DEVIATION 11.08 • n=7 Participants
|
48.3 years
STANDARD_DEVIATION 11.07 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
East Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to Safety follow-up (up to 28 weeks)Population: Safety set included all participants who received at least 1 dose of study drug in the treatment period.
Outcome measures
| Measure |
ALPN-101 (Acazicolcept)
n=38 Participants
Participants received a weight-based dose of 3mg/kg ALPN-101 Q2W up to 24 weeks.
|
Placebo
n=38 Participants
Participants received placebo matched to ALPN-101 up to 24 weeks.
|
|---|---|---|
|
Safety and Tolerability as Assessed by Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Participants with TEAEs
|
23 Participants
|
24 Participants
|
|
Safety and Tolerability as Assessed by Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Participants with SAEs
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: At Day 169Population: Modified intent-to-treat population (mITT), includes all randomized participants who received any amount of study drug and have completed at least one post-baseline disease assessment. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
The SRI-4 is a composite index of SLE disease improvement that consists of scores derived from the SLE Disease Activity Index 2000 (SLEDAI-2K), the British Isles Lupus Assessment Group (BILAG) 2004 Index, and the Physician's Global Assessment (PGA). Participants classified as responder if they met all of the following criteria: 1) ≥ 4-point reduction in the SLEDAI-2K total score; 2) no new severe disease activity (BILAG A organ score) or more than 1 new moderate organ score (BILAG B) compared with baseline; and 3) No worsening from baseline in participants' lupus disease activity (i.e., increase of ≥0.3 0 on a 3-point scale) in PGA. The SLEDAI-2K total score falls between 0 and 105, with higher scores representing increased disease activity. SLEDAI-2K: assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). BILAG: assesses disease extent, severity (range: A\[severe\] to E\[no disease\]). PGA: assesses worsening in participant's general health.
Outcome measures
| Measure |
ALPN-101 (Acazicolcept)
n=37 Participants
Participants received a weight-based dose of 3mg/kg ALPN-101 Q2W up to 24 weeks.
|
Placebo
n=37 Participants
Participants received placebo matched to ALPN-101 up to 24 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving a Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4
|
27 percentage of participants
|
46 percentage of participants
|
PRIMARY outcome
Timeframe: At Day 169Population: mITT includes all randomized participants who received any amount of study drug and have completed at least one post-baseline disease assessment. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
The BICLA is a responder index developed to measure response to therapy, and it includes scores from the BILAG, SLEDAI-2K, and Physician's Global Assessment (PGA). BICLA response is defined as: 1) at least 1 gradation of improvement in baseline BILAG 2004 scores in all body systems with moderate disease activity at entry (eg, all B \[mild disease\] scores falling to C \[Stable and mild\], or D \[no activity\]); 2) no new BILAG A or more than 1 new BILAG B scores; 3) no worsening of total SLEDAI-2K score from baseline; 4) ≤ 10% deterioration in PGA score. The PGA is measured on a 0 to 100 mm scale with score 0 indicates No Disease Activity and score 100 indicates the most Severe Disease Activity.
Outcome measures
| Measure |
ALPN-101 (Acazicolcept)
n=37 Participants
Participants received a weight-based dose of 3mg/kg ALPN-101 Q2W up to 24 weeks.
|
Placebo
n=37 Participants
Participants received placebo matched to ALPN-101 up to 24 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving a British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) Response
|
22 percentage of participants
|
32 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline to Day 169Population: mITT includes all randomized participants who received any amount of study drug and have completed at least one post-baseline disease assessment. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. Data was planned to be reported as LS Mean and Standard Error.
The BILAG-2004 index covers 86 questions item assessed across 9 organ systems. Each question is answered as 0-not present, 1-improving, 2- same, 3-worse, to 4-new. The BILAG-2004 index categorizes disease activity in each organ system into five different levels from A to E. Grade A represents requires disease-modifying treatment, Grade B represents mild, reversible problems requiring symptomatic therapy, Grade C indicates mild stable disease, and grade D implies no disease activity, but suggests the organ system had previously been affected. Grade E indicates no current or previous disease activity. Higher scores indicate more severe disease activity. Annualized flare rate is defined as the number of flares observed during the treatment period divided by the flare exposure time in days multiplied by 365.25.
Outcome measures
| Measure |
ALPN-101 (Acazicolcept)
n=37 Participants
Participants received a weight-based dose of 3mg/kg ALPN-101 Q2W up to 24 weeks.
|
Placebo
n=37 Participants
Participants received placebo matched to ALPN-101 up to 24 weeks.
|
|---|---|---|
|
Annualized Flare Rate by British Isles Lupus Assessment Group (BILAG)-2004 Flare Index
|
3.27 Flares per person-years
Standard Error 0.426
|
2.80 Flares per person-years
Standard Error 0.426
|
SECONDARY outcome
Timeframe: From Baseline to Day 169Population: mITT includes all randomized participants who received any amount of study drug and have completed at least one post-baseline disease assessment. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Time-to-first SLE flare is defined as the number of days from the administration of first dose to the first occurrence of flare. A flare was defined as having an adjudicated BILAG A or B score in any of the 8 organ systems during treatment. The BILAG disease activity index evaluates SLE activity in 8 organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows. BILAG A: Disease sufficiently active requiring disease modifying treatment (prednisone greater than 20 mg daily or immunosuppressants); BILAG B: Disease less active than in "A", mild reversible problems requiring only symptomatic therapy such as antimalarials, NSAIDs, or prednisone less than 20 mg day; BILAG C: Stable mild disease; BILAG D: System previously affected but now inactive; BILAG E: System never involved.
Outcome measures
| Measure |
ALPN-101 (Acazicolcept)
n=37 Participants
Participants received a weight-based dose of 3mg/kg ALPN-101 Q2W up to 24 weeks.
|
Placebo
n=37 Participants
Participants received placebo matched to ALPN-101 up to 24 weeks.
|
|---|---|---|
|
Time-to-first Flare by BILAG-2004 Flare Index
|
85.0 days
Interval 57.0 to 112.0
|
113.0 days
Interval 85.0 to 115.0
|
SECONDARY outcome
Timeframe: At Day 169Population: mITT includes all randomized participants who received any amount of study drug and have completed at least one post-baseline disease assessment. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
The LLDAS is a composite measure designed to identify patients achieving a state of low disease activity. LLDAS was defined as SLE disease activity index (SLEDAI-2k \<=4, with no activity in major organ systems (CNS, vascular, renal, cardiorespiratory and constitutional); where "no activity" is defined as all items of SLEDAI-2K within these major organ systems equal to 0; No new features of lupus disease activity compared to previous occurred visit, where the "new feature" is defined as any of the SLEDAI-2K 24 items changed from 0 to greater than 0; PGA (scale 0-3 higher scores = higher severity), \<=1; current prednisolone (or equivalent) dose \<=7.5 mg daily; and allowance for maintenance doses of immunosuppressive drugs and approved biological agents.
Outcome measures
| Measure |
ALPN-101 (Acazicolcept)
n=37 Participants
Participants received a weight-based dose of 3mg/kg ALPN-101 Q2W up to 24 weeks.
|
Placebo
n=37 Participants
Participants received placebo matched to ALPN-101 up to 24 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving a Lupus Low Disease Activity State (LLDAS)
|
14 percentage of participants
|
16 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline to Day 169Population: mITT includes all randomized participants who received any amount of study drug and have completed at least one post-baseline disease assessment. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
SLEDAI-2K score is a disease activity score used to identify patients with more active disease at enrolment in study. Total score is defined as the sum of the weighted scores of each individual item within each organ system class. For each system organ with baseline score \>0, improvement in SLEDAI-2K improvement is achieved by meeting all the following criteria: * Reduction in system organ scores among participants with baseline SLEDAI-2K scores greater than 0 * No early discontinuation of study drug * No use of restricted medications beyond the protocol-allowed threshold before assessment SLEDAI-2K uses a weighted checklist to assign a numerical score based on the presence or absence of 24 symptoms. Each symptom present is assigned between 1 and 8 points based on its usual clinical importance, yielding a total score that ranges from 0 points (no symptoms) to 105 points (presence of all defined symptoms).
Outcome measures
| Measure |
ALPN-101 (Acazicolcept)
n=37 Participants
Participants received a weight-based dose of 3mg/kg ALPN-101 Q2W up to 24 weeks.
|
Placebo
n=37 Participants
Participants received placebo matched to ALPN-101 up to 24 weeks.
|
|---|---|---|
|
Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Total Score
|
-2.4 score on a scale
Interval -3.3 to -1.6
|
-3.0 score on a scale
Interval -3.8 to -2.2
|
SECONDARY outcome
Timeframe: From Baseline through Day 169Population: mITT includes all randomized participants who received any amount of study drug and have completed at least one post-baseline disease assessment. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
ALPN-101 (Acazicolcept)
n=37 Participants
Participants received a weight-based dose of 3mg/kg ALPN-101 Q2W up to 24 weeks.
|
Placebo
n=37 Participants
Participants received placebo matched to ALPN-101 up to 24 weeks.
|
|---|---|---|
|
Cumulative Prednisone-equivalent Dose Use Through Day 169
|
1028.28 milligram (mg)
Standard Error 183.729
|
854.59 milligram (mg)
Standard Error 183.729
|
SECONDARY outcome
Timeframe: From Baseline to Day 169Population: mITT includes all randomized participants who received any amount of study drug and have completed at least one post-baseline disease assessment. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
CLASI is an validated measurement instrument for lupus erythematosus developed for use in clinical studies that consists of separate scores for the activity of the disease. CLASI Activity is scored based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and nonscarring alopecia. The total CLASI activity score ranges from 0-70, with higher scores indicating more severe skin disease.
Outcome measures
| Measure |
ALPN-101 (Acazicolcept)
n=10 Participants
Participants received a weight-based dose of 3mg/kg ALPN-101 Q2W up to 24 weeks.
|
Placebo
n=11 Participants
Participants received placebo matched to ALPN-101 up to 24 weeks.
|
|---|---|---|
|
Percentage of Participants With ≥ 50% Reduction In CLASI Activity Score In Participants With Baseline CLASI Activity Score ≥ 8
|
30 percentage of participants
|
45 percentage of participants
|
Adverse Events
ALPN-101 (Acazicolcept)
Placebo
Serious adverse events
| Measure |
ALPN-101 (Acazicolcept)
n=38 participants at risk
Participants received a weight-based dose of 3mg/kg ALPN-101 Q2W up to 24 weeks.
|
Placebo
n=38 participants at risk
Participants received placebo matched to ALPN-101 up to 24 weeks.
|
|---|---|---|
|
Investigations
Haemoglobin Decreased
|
2.6%
1/38 • Day 1 up to Safety follow-up (up to 28 weeks)
Safety set included all participants who received at least 1 dose of study drug in the treatment period.
|
0.00%
0/38 • Day 1 up to Safety follow-up (up to 28 weeks)
Safety set included all participants who received at least 1 dose of study drug in the treatment period.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/38 • Day 1 up to Safety follow-up (up to 28 weeks)
Safety set included all participants who received at least 1 dose of study drug in the treatment period.
|
2.6%
1/38 • Day 1 up to Safety follow-up (up to 28 weeks)
Safety set included all participants who received at least 1 dose of study drug in the treatment period.
|
|
Psychiatric disorders
Mental Status Changes
|
2.6%
1/38 • Day 1 up to Safety follow-up (up to 28 weeks)
Safety set included all participants who received at least 1 dose of study drug in the treatment period.
|
0.00%
0/38 • Day 1 up to Safety follow-up (up to 28 weeks)
Safety set included all participants who received at least 1 dose of study drug in the treatment period.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/38 • Day 1 up to Safety follow-up (up to 28 weeks)
Safety set included all participants who received at least 1 dose of study drug in the treatment period.
|
2.6%
1/38 • Day 1 up to Safety follow-up (up to 28 weeks)
Safety set included all participants who received at least 1 dose of study drug in the treatment period.
|
Other adverse events
| Measure |
ALPN-101 (Acazicolcept)
n=38 participants at risk
Participants received a weight-based dose of 3mg/kg ALPN-101 Q2W up to 24 weeks.
|
Placebo
n=38 participants at risk
Participants received placebo matched to ALPN-101 up to 24 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Aphthous Ulcer
|
10.5%
4/38 • Day 1 up to Safety follow-up (up to 28 weeks)
Safety set included all participants who received at least 1 dose of study drug in the treatment period.
|
0.00%
0/38 • Day 1 up to Safety follow-up (up to 28 weeks)
Safety set included all participants who received at least 1 dose of study drug in the treatment period.
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.3%
2/38 • Day 1 up to Safety follow-up (up to 28 weeks)
Safety set included all participants who received at least 1 dose of study drug in the treatment period.
|
2.6%
1/38 • Day 1 up to Safety follow-up (up to 28 weeks)
Safety set included all participants who received at least 1 dose of study drug in the treatment period.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
2/38 • Day 1 up to Safety follow-up (up to 28 weeks)
Safety set included all participants who received at least 1 dose of study drug in the treatment period.
|
0.00%
0/38 • Day 1 up to Safety follow-up (up to 28 weeks)
Safety set included all participants who received at least 1 dose of study drug in the treatment period.
|
|
Gastrointestinal disorders
Food Poisoning
|
0.00%
0/38 • Day 1 up to Safety follow-up (up to 28 weeks)
Safety set included all participants who received at least 1 dose of study drug in the treatment period.
|
5.3%
2/38 • Day 1 up to Safety follow-up (up to 28 weeks)
Safety set included all participants who received at least 1 dose of study drug in the treatment period.
|
|
Infections and infestations
Urinary Tract Infection
|
10.5%
4/38 • Day 1 up to Safety follow-up (up to 28 weeks)
Safety set included all participants who received at least 1 dose of study drug in the treatment period.
|
5.3%
2/38 • Day 1 up to Safety follow-up (up to 28 weeks)
Safety set included all participants who received at least 1 dose of study drug in the treatment period.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
2.6%
1/38 • Day 1 up to Safety follow-up (up to 28 weeks)
Safety set included all participants who received at least 1 dose of study drug in the treatment period.
|
5.3%
2/38 • Day 1 up to Safety follow-up (up to 28 weeks)
Safety set included all participants who received at least 1 dose of study drug in the treatment period.
|
|
Infections and infestations
COVID-19
|
0.00%
0/38 • Day 1 up to Safety follow-up (up to 28 weeks)
Safety set included all participants who received at least 1 dose of study drug in the treatment period.
|
7.9%
3/38 • Day 1 up to Safety follow-up (up to 28 weeks)
Safety set included all participants who received at least 1 dose of study drug in the treatment period.
|
|
Infections and infestations
Influenza
|
0.00%
0/38 • Day 1 up to Safety follow-up (up to 28 weeks)
Safety set included all participants who received at least 1 dose of study drug in the treatment period.
|
5.3%
2/38 • Day 1 up to Safety follow-up (up to 28 weeks)
Safety set included all participants who received at least 1 dose of study drug in the treatment period.
|
|
General disorders
Asthenia
|
5.3%
2/38 • Day 1 up to Safety follow-up (up to 28 weeks)
Safety set included all participants who received at least 1 dose of study drug in the treatment period.
|
0.00%
0/38 • Day 1 up to Safety follow-up (up to 28 weeks)
Safety set included all participants who received at least 1 dose of study drug in the treatment period.
|
|
General disorders
Influenza Like Illness
|
0.00%
0/38 • Day 1 up to Safety follow-up (up to 28 weeks)
Safety set included all participants who received at least 1 dose of study drug in the treatment period.
|
5.3%
2/38 • Day 1 up to Safety follow-up (up to 28 weeks)
Safety set included all participants who received at least 1 dose of study drug in the treatment period.
|
|
Immune system disorders
Infusion Related Reaction
|
5.3%
2/38 • Day 1 up to Safety follow-up (up to 28 weeks)
Safety set included all participants who received at least 1 dose of study drug in the treatment period.
|
0.00%
0/38 • Day 1 up to Safety follow-up (up to 28 weeks)
Safety set included all participants who received at least 1 dose of study drug in the treatment period.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.3%
2/38 • Day 1 up to Safety follow-up (up to 28 weeks)
Safety set included all participants who received at least 1 dose of study drug in the treatment period.
|
0.00%
0/38 • Day 1 up to Safety follow-up (up to 28 weeks)
Safety set included all participants who received at least 1 dose of study drug in the treatment period.
|
|
Nervous system disorders
Headache
|
5.3%
2/38 • Day 1 up to Safety follow-up (up to 28 weeks)
Safety set included all participants who received at least 1 dose of study drug in the treatment period.
|
13.2%
5/38 • Day 1 up to Safety follow-up (up to 28 weeks)
Safety set included all participants who received at least 1 dose of study drug in the treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
2.6%
1/38 • Day 1 up to Safety follow-up (up to 28 weeks)
Safety set included all participants who received at least 1 dose of study drug in the treatment period.
|
5.3%
2/38 • Day 1 up to Safety follow-up (up to 28 weeks)
Safety set included all participants who received at least 1 dose of study drug in the treatment period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place