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History of Changes for Study: NCT04835441
ALPN-101 (Acazicolcept) in Systemic Lupus Erythematosus (Synergy)
Latest version (submitted April 26, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 5, 2021 None (earliest Version on record)
2 April 6, 2021 Outcome Measures and Study Status
3 April 9, 2021 Study Status, Oversight, Eligibility, Outcome Measures and Arms and Interventions
4 June 24, 2021 Recruitment Status, Study Status, Outcome Measures, Contacts/Locations, Study Description, Oversight and Study Identification
5 August 4, 2021 Contacts/Locations and Study Status
6 September 1, 2021 Study Status and Eligibility
7 September 2, 2021 Contacts/Locations and Study Status
8 October 15, 2021 Study Status and Contacts/Locations
9 November 5, 2021 Study Status and Contacts/Locations
10 December 14, 2021 Contacts/Locations and Study Status
11 February 14, 2022 Contacts/Locations and Study Status
12 June 28, 2022 Contacts/Locations and Study Status
13 July 8, 2022 Contacts/Locations and Study Status
14 August 24, 2022 Contacts/Locations and Study Status
15 October 14, 2022 Study Status and Contacts/Locations
16 January 3, 2023 Contacts/Locations, Eligibility, Arms and Interventions, Study Status and Study Identification
17 January 17, 2023 Contacts/Locations and Study Status
18 February 22, 2023 Contacts/Locations and Study Status
19 March 14, 2023 Contacts/Locations and Study Status
20 April 28, 2023 Study Status and Contacts/Locations
21 June 6, 2023 Contacts/Locations and Study Status
22 June 13, 2023 Contacts/Locations and Study Status
23 August 7, 2023 Study Status, Contacts/Locations and Study Description
24 September 5, 2023 Study Status and Contacts/Locations
25 October 6, 2023 Contacts/Locations and Study Status
26 November 10, 2023 Contacts/Locations and Study Status
27 November 22, 2023 Contacts/Locations and Study Status
28 November 29, 2023 Contacts/Locations and Study Status
29 December 15, 2023 Contacts/Locations and Study Status
30 January 4, 2024 Study Status and Contacts/Locations
31 January 26, 2024 Recruitment Status, Contacts/Locations and Study Status
32 February 1, 2024 Study Status
33 February 15, 2024 Study Status
34 March 1, 2024 Study Status
35 March 15, 2024 Study Status
36 April 4, 2024 Study Status
37 April 26, 2024 Study Status
Comparison Format:

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Changes (Merged) for Study: NCT04835441
June 13, 2023 (v22) -- August 7, 2023 (v23)

Changes in: Study Status, Study Description and Contacts/Locations

Open or close this module Study Identification
Unique Protocol ID: AIS-A03
Brief Title: ALPN-101 (Acazicolcept) in Systemic Lupus Erythematosus (Synergy)
Official Title: A Randomized, Double-blind, Placebo-controlled Study of ALPN-101 in Systemic Lupus Erythematosus
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2023 August 2023
Overall Status: Recruiting
Study Start: June 22, 2021
Primary Completion: November 2023 2024 [Anticipated]
Study Completion: January 2024 2025 [Anticipated]
First Submitted: April 5, 2021
First Submitted that
Met QC Criteria:
April 5, 2021
First Posted: April 8, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
June 13, 2023 August 7, 2023
Last Update Posted: June 15 August 9, 2023 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Alpine Immune Sciences, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module Study Description
Brief 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)
Detailed Description:
Open or close this module Conditions
Conditions: Systemic Lupus Erythematosus
Keywords: CD28
ICOS
Autoimmune disease
Immune system disease
Immunosuppressive agent
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 130 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: ALPN-101 (acazicolcept) Drug: ALPN-101
Blinded ALPN-101 will be administered
Placebo Comparator: Placebo Drug: Placebo
Blinded placebo matching ALPN-101 will be administered.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Adverse Events
[ Time Frame: From study Day 1 until End of Study (28 weeks) ]

Type, incidence, and severity of adverse events as assessed by CTCAE
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 70 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Key Inclusion Criteria Summary

  • 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

Key Exclusion Criteria Summary:

  • 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
  • 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
Open or close this module Contacts/Locations
Central Contact Person: Marcus Martin Rosalie Samalenge
Telephone: 1 404 309 8902 443 821 1415
Email: Marcus rosalie. Martin samalenge@parexel.com
Study Officials: Rachel Peterson, MD
Study Director
Alpine Immune Sciences, Inc.
Locations: United States, Alabama
Investigational Site (107)
[Recruiting]
Anniston, Alabama, United States, 36207
United States, Arizona
Investigational Site (189)
[Recruiting]
Phoenix, Arizona, United States, 85037
Investigational Site (158)
[Recruiting]
Tucson, Arizona, United States, 85704
United States, California
Investigational Site (174)
[Recruiting]
La Jolla, California, United States, 92037
Investigational Site (155)
[Recruiting]
Los Angeles, California, United States, 90022
Investigational Site (109)
[Completed]
San Diego, California, United States, 92020
Investigational Site (169)
[Recruiting]
Santa Barbara, California, United States, 93108
United States, Florida
Investigational Site (106)
[Recruiting]
DeBary, Florida, United States, 32713
Investigational Site (170)
[Recruiting]
Fort Lauderdale, Florida, United States, 33309
Investigational Site (120)
[Recruiting]
Hialeah, Florida, United States, 33016
Investigational Sites (134)
[Recruiting]
Miami, Florida, United States, 33165
Investigational Site (152)
[Recruiting]
Ormond Beach, Florida, United States, 32174
Investigational Site (133)
[Recruiting]
Plantation, Florida, United States, 33324
Investigational Site (190)
[Recruiting]
Tamarac, Florida, United States, 33321
Investigational Site (163)
[Completed]
Tampa, Florida, United States, 33606
United States, Idaho
Investigational Site (173)
[Completed]
Idaho Falls, Idaho, United States, 83404
United States, Illinois
Investigational Site (156)
[Recruiting]
Skokie, Illinois, United States, 60076
United States, Kentucky
Investigational Site (154)
[Recruiting]
Bowling Green, Kentucky, United States, 42101
United States, Michigan
Investigational Site (138)
[Recruiting]
Grand Blanc, Michigan, United States, 48439
United States, Nevada
Investigational Site (164)
[Recruiting]
Las Vegas, Nevada, United States, 89128
United States, New York
Investigational Site (175)
[Recruiting]
Brooklyn, New York, United States, 11220
Investigational Site (115)
[Recruiting]
Manhasset, New York, United States, 11030
United States, North Carolina
Investigational Site (179)
[Recruiting]
Charlotte, North Carolina, United States, 28277
United States, Tennessee
Investigational Site (112)
[Completed]
Crossville, Tennessee, United States, 38555
Investigational Site (145)
[Recruiting]
Jackson, Tennessee, United States, 38305
Investigational Site (186)
[Recruiting]
Memphis, Tennessee, United States, 38119
United States, Texas
Investigational Site (171)
[Recruiting]
Baytown, Texas, United States, 77521
Investigational Site (143)
[Completed]
Bellaire, Texas, United States, 77401
Investigational Site (118)
[Recruiting]
Colleyville, Texas, United States, 76034
Investigational Site (166)
[Recruiting]
Fort Worth, Texas, United States, 76107
Investigational Site (121)
[Recruiting]
Houston, Texas, United States, 77089
Investigational Site (104)
[Recruiting]
Mesquite, Texas, United States, 75150
Investigational Site (162)
[Recruiting]
San Antonio, Texas, United States, 78215
Investigational Site (127)
[Recruiting]
San Antonio, Texas, United States, 78229
United States, Virginia
Investigational Site (178)
[Recruiting]
Roanoke, Virginia, United States, 24016
France
Investigational Site (149)
[Recruiting]
Marseille, France, 13285
Investigational Site (123)
[Recruiting]
Nice, France
Investigational Site (128)
[Recruiting]
Paris, France
Investigational Site (161)
[Recruiting]
Paris, France
France, Bourgogne
Investigational Site (124)
[Recruiting]
Dijon, Bourgogne, France, 21000
Hungary
Investigational Site (181)
[Recruiting]
Budapest, Hungary
Investigational Site (180)
[Recruiting]
Gyula, Hungary
Investigational Site (183)
[Recruiting]
Székesfehérvár, Hungary
Korea, Republic of
Investigational Site (125)
[Recruiting]
Seoul, Korea, Republic of, 3080
Investigational Site (116)
[Recruiting]
Suwon, Korea, Republic of, 16499
Korea, Republic of, Gwangu
Investigational Site (117)
[Recruiting]
Donggu, Gwangu, Korea, Republic of, 61469
Poland
Investigational Site (160)
[Recruiting]
Elbląg, Poland
Investigational Site (110)
[Recruiting]
Kraków, Poland, 30-363
Investigational Site (108)
[Recruiting]
Poznań, Poland, 60-848
Investigational Site (119)
[Recruiting]
Poznań, Poland, 61-397
Investigational Site (165)
[Recruiting]
Wrocław, Poland, 50-244
Puerto Rico
Investigational Site (191)
[Recruiting]
Caguas, Puerto Rico, 00725
Investigational Site (187)
[Recruiting]
San Juan, Puerto Rico, 00914
Spain
Investigational Site (137)
[Recruiting]
Coruna, Spain, 15006
Investigational Site (126)
[Recruiting]
Madrid, Spain, 28905
Investigational Site (139)
[Recruiting]
Sevilla, Spain, 41010
Investigational Site (188)
[Recruiting]
Sevilla, Spain, 41014
Investigational Site (142)
[Recruiting]
Seville, Spain
Taiwan
Investigational Site (185)
[Recruiting]
Hualien City, Taiwan
Investigational Site (184)
[Recruiting]
Taichung, Taiwan
Investigational Site (182)
[Recruiting]
Taipei, Taiwan
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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