ALPN-101 (Acazicolcept) in Systemic Lupus Erythematosus

Study Purpose

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)

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 70 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04835441
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Alpine Immune Sciences, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Rachel Peterson, MD
Principal Investigator Affiliation	Alpine Immune Sciences, Inc.
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	France, Hungary, Korea, Republic of, Poland, Puerto Rico, Spain, Taiwan, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Systemic Lupus Erythematosus

Arms & Interventions

Arms

Experimental: ALPN-101 (acazicolcept)

Placebo Comparator: Placebo

Interventions

Drug: - ALPN-101

Blinded ALPN-101 will be administered

Drug: - Placebo

Blinded placebo matching ALPN-101 will be administered.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Investigational Site (107), Anniston, Alabama

Status

Completed

Address

Investigational Site (107)

Anniston, Alabama, 36207

Site Contact

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