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Not recruiting
Phase 2

Solrikitug

Sponsor:

Uniquity One (UNI)

Code:

NCT06496620

Conditions

COPD

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Biological: Solrikitug low dose

Biological: Solrikitug high dose

Placebo

Study Details

Brief summary:

A Randomized, Double-blind, Placebo-controlled, Multiple Dose-Ranging Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Solrikitug in Participants with Chronic Obstructive Pulmonary Disease (COPD).

Conditions

COPD

Study ID

NCT06496620

Start date

Aug 14, 2024

Status verified date

Aug, 2026

Completion date

Feb 1, 2027

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • At least 40 years of age and no older than 75 years.
  • Documented diagnosis of COPD for at least 12 months prior to Screening, defined by the GOLD Guidelines (2023), and elevated blood eosinophils at screening.
  • At Screening FEV1/FVC ratio must be <0.70, and Post-bronchodilator FEV1 must be ≥40% to <80% predicted normal value calculated using Global Lung Function Initiative (GLI) reference equations (Cooper et al 2017).
  • Symptomatic (COPD Assessment Test \[CAT\] Score ≥10) at Screening Visit 1.
  • Participants must be on 2 or more inhaled maintenance medications for management of their COPD, for at least 3 months prior to screening.

Exclusion Criteria:

  • Female participant who is pregnant or breastfeeding.
  • Participant has a known hypersensitivity to any component of the formulation of solrikitug, including any of the excipients, or a history of anaphylactic reaction to any therapeutic monoclonal antibody.
  • Participant has history or evidence of any clinically significant cardiovascular, hematologic, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, renal and/or other major disease or malignancy, or any other condition that in the opinion of the Investigator or Medical Monitor might obfuscate the study data.
  • Any other pulmonary disease than COPD that in the opinion of the Investigator, the severity of the disorder would impact the conduct of the study.
  • Undergone major lung surgery, within 1 year of Screening Visit 1.
  • Participant has a lower respiratory tract infection that required antibiotics within 6 weeks prior to Screening.

Study Design

Enrollment

182 participants

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Biological: Solrikitug High Dose

Solrikitug

other: Placebo

Placebo

experimental: Biological: Solrikitug Low Dose

Solrikitug

Interventions

Biological: Solrikitug low dose

Solrikitug subcutaneous injection

Biological: Solrikitug high dose

Solrikitug subcutaneous injection

Placebo

Placebo subcutaneous injection

Primary outcome measure

  • Change from baseline in blood eosinophil counts [ Time Frame: Through week 12 ]

Central Contacts and Locations

More Information

Sponsor

Uniquity One (UNI)

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by Uniquity One (UNI) on 2026-08-11.