Clinical Trials

Alpine is committed to bringing innovative new drug therapies to patients with serious or life-threatening diseases or conditions.

Acazicolcept (ALPN-101)

PhasePhasePhase
2AIS-A03
Alpine Synergy Logo
A Randomized, Double Blind, Placebo-Controlled Study of ALPN-101 in Systemic Lupus Erythematosus

Details

We are currently enrolling Synergy, a phase 2 study of acazicolcept in patients with Systemic Lupus Erythematosus (NCT04835441). This randomized, double-blind, placebo-controlled study was designed to evaluate the safety, tolerability, efficacy, immunogenicity, pharmacokinetics, and pharmacodynamics of acazicolcept.

We completed enrollment in a phase 1 study of acazicolcept in healthy volunteers (NCT03748836). This study was designed to evaluate the safety and tolerability of single and multiple ascending intravenous and/or subcutaneous doses of acazicolcept. In addition, pharmacokinetics, pharmacodynamics, and exploratory biomarkers were evaluated to help determine acazicolcept’s potential for the treatment of inflammatory diseases. Results from the single ascending dose, or SAD, portion of the study were discussed at an oral presentation at the 2019 ASH Annual Meeting. Final data were presented at the 2020 EULAR E-Congress.

Learn More About acazicolcept AIS-A03

Davoceticept (ALPN-202)

PhaseTrialIndication
1AIS-B01
Neon 1
An Open-label Study of ALPN-202 in Subjects with Advanced Malignancies (NEON-1)
1AIS-B02
Neon 2
An Open-Label Study of ALPN-202 Combined with PD-1 inhibition in Subjects with Advanced Malignancies (NEON-2)

Details

In October 2022, we voluntarily terminated enrollment in both clinical studies involving davoceticept (ALPN-202) including the NEON-1 (NCT04186637) study of davoceticept as monotherapy and the NEON-2 (NCT04920383) study of davoceticept in combination with pembrolizumab. We are conducting an ongoing, comprehensive assessment of all NEON study participants.

Learn More About Davoceticept AIS-B01Learn More About Davoceticept AIS-B02

ALPN-303

PhaseTrialIndication
1AIS-D01
Ruby 1
A Study of ALPN-303 in Adult Healthy Volunteers

Details

We reported initial data from the ongoing RUBY-1 study, a phase 1 study of ALPN-303 in healthy volunteers (NCT05034484) in September 2022. This study is designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of ALPN-303.

Learn More About ALPN-303 AIS-D01

Expanded Access

Alpine is committed to bringing innovative new drug therapies to patients with serious or life-threatening diseases or conditions. Participation in a clinical trial is currently the most appropriate way to access our investigational therapies.

In line with the 21st Century Cures Act (Pub.L. 114-255), Alpine may revise this policy at any time.

Additional Resources

Join us in the discovery and development of next-generation immunotherapies.

Current job openingsLearn more about Alpine