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Systemic Lupus ErythematosusPhase 2SynergyNCT04835441

ALPN-101 (Acazicolcept) in Systemic Lupus Erythematosus

A Phase 2 study testing ALPN-101 in people with Systemic Lupus Erythematosus, run by Alpine Immune Sciences Inc, A Subsidiary of Vertex at 46 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is Phase 2, multinational, randomized, blinded study to evaluate the safety, tolerability, efficacy, immunogenicity, pharmacokinetics and pharmacodynamics of ALPN-101 (acazicolcept) in adults with moderate to severe active systemic lupus erythematosus (SLE) Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
ALPN-101
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
76 participants
Where
46 sitesin 7 countries
Study dates
22 Jun 2021to 9 Jul 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • SLE onset ≥ 6 months prior to Screening
  • Positive ANA and/or elevated anti-dsDNA and/or elevated anti-Smith antibody test
  • Active lupus at Screening and Baseline, as defined per-protocol and confirmed by the study's medical monitor, including a SLEDAI score at Screening of ≥ 6 and a clinical score at Baseline of ≥ 4
  • Standard lupus medications must be stable prior to Screening

Who cannot join

  • Life-threatening or organ system-threatening lupus activity that is anticipated to require increased treatment during the study
  • Proteinuria consistent with nephrotic syndrome
  • Active lupus-related neuropsychiatric disease
  • Drug-induced lupus
  • Recent or serious ongoing infection; risk or history of serious infection
  • Receipt of live vaccination within 8 weeks of Day 1, or expected to require live vaccination during the study
Show all 10Show fewer
  • Prior diagnosis of, or fulfills diagnostic criteria for, another rheumatic disease that overlaps with lupus or another autoimmune or inflammatory disease that may confound clinical assessments or increase subject risk in the study
  • Diagnosis of, or fulfills diagnostic criteria for fibromyalgia
  • Functional class IV
  • Serious lupus disease activity, which warrants immediate immunosuppressive therapy not appropriate for the study or which makes the possibility of receiving placebo or investigational agent an inappropriate risk

Trial locations and contacts

46 sites in 7 countries.

46 sites in 7 countries

United States29 sites

  • Investigational Site (107)

    Anniston, Alabama, 36207

  • Investigational Site (171)

    Baytown, Texas, 77521

  • Investigational Site (143)

    Bellaire, Texas, 77401

  • Investigational Site (175)

    Brooklyn, New York, 11220

  • Investigational Site (179)

    Charlotte, North Carolina, 28277

  • Investigational Site (118)

    Colleyville, Texas, 76034

  • Investigational Site (112)

    Crossville, Tennessee, 38555

  • Investigational Site (106)

    DeBary, Florida, 32713

  • Investigational Site (166)

    Fort Worth, Texas, 76107

  • Investigational Site (138)

    Grand Blanc, Michigan, 48439

  • Investigational Site (120)

    Hialeah, Florida, 33016

  • Investigational Site (121)

    Houston, Texas, 77089

  • Investigational Site (173)

    Idaho Falls, Idaho, 83404

  • Investigational Site (164)

    Las Vegas, Nevada, 89128

  • Investigational Site (155)

    Los Angeles, California, 90022

  • Investigational Site (115)

    Manhasset, New York, 11030

  • Investigational Site (186)

    Memphis, Tennessee, 38119

  • Investigational Site (104)

    Mesquite, Texas, 75150

  • Investigational Sites (134)

    Miami, Florida, 33165

  • Investigational Site (152)

    Ormond Beach, Florida, 32174

  • Investigational Site (189)

    Phoenix, Arizona, 85037

  • Investigational Site (133)

    Plantation, Florida, 33324

  • Investigational Site (162)

    San Antonio, Texas, 78215

  • Investigational Site (127)

    San Antonio, Texas, 78229

  • Investigational Site (109)

    San Diego, California, 92020

  • Investigational Site (169)

    Santa Barbara, California, 93108

  • Investigational Site (156)

    Skokie, Illinois, 60076

  • Investigational Site (190)

    Tamarac, Florida, 33321

  • Investigational Site (163)

    Tampa, Florida, 33606

Other trials in United States

Poland5 sites

  • Investigational Site (160)

    Elblag

  • Investigational Site (110)

    Krakow, 30-363

  • Investigational Site (108)

    Poznan, 60-848

  • Investigational Site (119)

    Poznan, 61-397

  • Investigational Site (165)

    Wroclaw, 50-244

Other trials in Poland

France3 sites

  • Investigational Site (149)

    Marseille, 13285

  • Investigational Site (128)

    Paris

  • Investigational Site (161)

    Paris

Other trials in France

Hungary3 sites

  • Investigational Site (181)

    Budapest

  • Investigational Site (180)

    Gyula

  • Investigational Site (183)

    Székesfehérvár

Other trials in Hungary

Puerto Rico2 sites

  • Investigational Site (191)

    Caguas, 00725

  • Investigational Site (187)

    San Juan, 00914

Other trials in Puerto Rico

Spain2 sites

  • Investigational Site (137)

    A Coruña, 15006

  • Investigational Site (139)

    Seville, 41010

Other trials in Spain

Taiwan2 sites

  • Investigational Site (184)

    Taichung

  • Investigational Site (182)

    Taipei

Other trials in Taiwan

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Study of ALPN-101 in Systemic Lupus Erythematosus

This is Phase 2, multinational, randomized, blinded study to evaluate the safety, tolerability, efficacy, immunogenicity, pharmacokinetics and pharmacodynamics of ALPN-101 (acazicolcept) in adults with moderate to severe active systemic lupus erythematosus (SLE)

Being tested
ALPN-101, Placebo
Keywords
CD28, ICOS, Autoimmune disease, Immune system disease, Immunosuppressive agent
Medical subject headings
Lupus Erythematosus, Systemic, Autoimmune Diseases, Immune System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ALPN-101Drug

    Also called Acazicolcept

    Intravenous infusion via an infusion pump.

  • PlaceboDrug

    Intravenous infusion via an infusion pump.

Study groups in NCT04835441
Study groupRoleWhat they receive
ALPN-101 (Acazicolcept)ExperimentalParticipants received a weight-based dose of 3 milligrams/kilogram (mg/kg) ALPN-101 once every 2 weeks (Q2W) up to 24 weeks.
Receives: Drug: ALPN-101
PlaceboPlacebo comparatorParticipants received placebo matched to ALPN-101 up to 24 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and Tolerability as Assessed by Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Measured: Day 1 up to Safety follow-up (up to 28 weeks)

  2. Percentage of Participants Achieving a Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4

    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.

    Measured: At Day 169

  3. Percentage of Participants Achieving a British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) Response

    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.

    Measured: At Day 169

Secondary outcomes (6)

  1. Annualized Flare Rate by British Isles Lupus Assessment Group (BILAG)-2004 Flare Index

    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.

    Measured: From Baseline to Day 169

  2. Time-to-first Flare by BILAG-2004 Flare Index

    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.

    Measured: From Baseline to Day 169

  3. Percentage of Participants Achieving a Lupus Low Disease Activity State (LLDAS)

    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.

    Measured: At Day 169

  4. Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Total Score

    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).

    Measured: From Baseline to Day 169

  5. Cumulative Prednisone-equivalent Dose Use Through Day 169

    Measured: From Baseline through Day 169

  6. Percentage of Participants With ≥ 50% Reduction In CLASI Activity Score In Participants With Baseline CLASI Activity Score ≥ 8

    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.

    Measured: From Baseline to Day 169

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2021
  2. Study start22 Jun 2021
  3. Primary completion9 Jul 2024
  4. Study completion9 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04835441
Sponsor's protocol ID
AIS-A03
Acronym
Synergy
Status last verified
Aug 2025
First submitted
5 Apr 2021
Last updated
15 Aug 2025
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ALPN-101 in people with Systemic Lupus Erythematosus, run by Alpine Immune Sciences Inc, A Subsidiary of Vertex at 46 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in United States, Poland, France, Hungary, Puerto Rico and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Tolerability as Assessed by Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: Day 1 up to Safety follow-up (up to 28 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04835441.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.

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