ALPN-101 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 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 - 65 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Written informed consent.
  • - Age 18 to 65.
  • - Diagnosis of lupus for ≥ 6 months prior to Screening.
  • - Positive ANA and/or elevated anti-dsDNA and/or elevated anti-Smith antibody test at Screening.
  • - 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.
  • - Women must have a PAP smear and known HPV status within 12 months of Day 1.
  • - All participants must use highly effective birth control if they/their partner are capable of becoming pregnant.

Exclusion Criteria:

  • - 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.
  • - Any serious health condition that would place the subject at undue risk from the study or would confound interpretation of safety or efficacy outcomes.
  • - 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.
  • - Unacceptable Screening laboratory results.
  • - History of new, ongoing, or recurrent malignancy ≤ 5 years prior to Day 1, with some exceptions per-protocol.
  • - Pregnant or breastfeeding at the time of screening, or plans to become pregnant ≤ 3 months following the last dose of study drug.
  • - 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 lupus.
  • - Does not meet protocol washout periods for concomitant medications.
  • - 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.
  • - Ongoing participation in another therapeutic clinical trial.
- Known hypersensitivity to ALPN-101, components thereof, or excipients contained in the drug formulation

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.

Pille Harrison, 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 Korea, Republic of, Poland, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Systemic Lupus Erythematosus
Arms & Interventions

Arms

Experimental: ALPN-101

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

Recruiting

Address

Investigational Site (107)

Anniston, Alabama, 36207

Investigational Site (158), Tucson, Arizona

Status

Recruiting

Address

Investigational Site (158)

Tucson, Arizona, 85704

Investigational Site (155), Los Angeles, California

Status

Recruiting

Address

Investigational Site (155)

Los Angeles, California, 90022

Investigational Site (109), San Diego, California

Status

Recruiting

Address

Investigational Site (109)

San Diego, California, 92020

Investigational Site (169), Santa Barbara, California

Status

Recruiting

Address

Investigational Site (169)

Santa Barbara, California, 93108

Investigational Site (106), DeBary, Florida

Status

Recruiting

Address

Investigational Site (106)

DeBary, Florida, 32713

Investigational Site (170), Fort Lauderdale, Florida

Status

Recruiting

Address

Investigational Site (170)

Fort Lauderdale, Florida, 33309

Investigational Site (120), Hialeah, Florida

Status

Recruiting

Address

Investigational Site (120)

Hialeah, Florida, 33016

Investigational Sites (134, 153), Miami, Florida

Status

Recruiting

Address

Investigational Sites (134, 153)

Miami, Florida, 33165

Investigational Site (152), Ormond Beach, Florida

Status

Recruiting

Address

Investigational Site (152)

Ormond Beach, Florida, 32174

Investigational Site (151), Palm Harbor, Florida

Status

Recruiting

Address

Investigational Site (151)

Palm Harbor, Florida, 34684

Investigational Site (133), Plantation, Florida

Status

Recruiting

Address

Investigational Site (133)

Plantation, Florida, 33324

Investigational Site (131), Port Orange, Florida

Status

Recruiting

Address

Investigational Site (131)

Port Orange, Florida, 32127

Investigational Site (163), Tampa, Florida

Status

Recruiting

Address

Investigational Site (163)

Tampa, Florida, 33606

Investigational Site (114), Atlanta, Georgia

Status

Recruiting

Address

Investigational Site (114)

Atlanta, Georgia, 30342

Investigational Site (173), Idaho Falls, Idaho

Status

Recruiting

Address

Investigational Site (173)

Idaho Falls, Idaho, 83404

Investigational Site (156), Skokie, Illinois

Status

Recruiting

Address

Investigational Site (156)

Skokie, Illinois, 60076

Investigational Site (154), Bowling Green, Kentucky

Status

Recruiting

Address

Investigational Site (154)

Bowling Green, Kentucky, 42101

Investigational Site (138), Grand Blanc, Michigan

Status

Recruiting

Address

Investigational Site (138)

Grand Blanc, Michigan, 48439

Investigational Site (164), Las Vegas, Nevada

Status

Recruiting

Address

Investigational Site (164)

Las Vegas, Nevada, 89128

Investigational Site (115), Manhasset, New York

Status

Recruiting

Address

Investigational Site (115)

Manhasset, New York, 11030

Investigational Site (167), Oklahoma City, Oklahoma

Status

Recruiting

Address

Investigational Site (167)

Oklahoma City, Oklahoma, 73102

Investigational Site (112), Crossville, Tennessee

Status

Recruiting

Address

Investigational Site (112)

Crossville, Tennessee, 38555

Investigational Site (145), Jackson, Tennessee

Status

Recruiting

Address

Investigational Site (145)

Jackson, Tennessee, 38305

Investigational Site (171), Baytown, Texas

Status

Recruiting

Address

Investigational Site (171)

Baytown, Texas, 77521

Investigational Site (143), Bellaire, Texas

Status

Recruiting

Address

Investigational Site (143)

Bellaire, Texas, 77401

Investigational Site (118), Colleyville, Texas

Status

Recruiting

Address

Investigational Site (118)

Colleyville, Texas, 76034

Investigational Site (166), Fort Worth, Texas

Status

Recruiting

Address

Investigational Site (166)

Fort Worth, Texas, 76107

Investigational Site (121), Houston, Texas

Status

Recruiting

Address

Investigational Site (121)

Houston, Texas, 77089

Investigational Site (172), Houston, Texas

Status

Recruiting

Address

Investigational Site (172)

Houston, Texas, 77095

Investigational Site (104), Mesquite, Texas

Status

Recruiting

Address

Investigational Site (104)

Mesquite, Texas, 75150

Investigational Site (162), San Antonio, Texas

Status

Recruiting

Address

Investigational Site (162)

San Antonio, Texas, 78215

International Sites

Investigational Site (122), Junggu, Daegu, Korea, Republic of

Status

Recruiting

Address

Investigational Site (122)

Junggu, Daegu, 41944

Investigational Site (117), Donggu, Gwangu, Korea, Republic of

Status

Recruiting

Address

Investigational Site (117)

Donggu, Gwangu, 61469

Investigational Site (125), Seoul, Korea, Republic of

Status

Recruiting

Address

Investigational Site (125)

Seoul, , 3080

Investigational Site (116), Suwon, Korea, Republic of

Status

Recruiting

Address

Investigational Site (116)

Suwon, , 16499

Investigational Site (110), Kraków, Poland

Status

Recruiting

Address

Investigational Site (110)

Kraków, , 30-363

Investigational Site (108), Poznań, Poland

Status

Recruiting

Address

Investigational Site (108)

Poznań, , 60-848

Investigational Site (119), Poznań, Poland

Status

Recruiting

Address

Investigational Site (119)

Poznań, , 61-397

Investigational Site (165), Wrocław, Poland

Status

Recruiting

Address

Investigational Site (165)

Wrocław, , 50-244

Investigational Site (113), Wrocław, Poland

Status

Recruiting

Address

Investigational Site (113)

Wrocław, , 51-124