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New treatment option for Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Official title Phase II Study of RC1416 Injection in COPD
ClinicalTrials.gov ID: NCT07402551
What this study is testing
What is RC1416?
RC1416 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for moderate to severe chronic obstructive pulmonary disease (copd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a multicenter, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy and safety of RC1416 injection in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 85
You may be able to join if
- Aged 40 to 85 years (inclusive) at the time of signing the informed consent form, regardless of gender.
- Body Mass Index (BMI) ≥ 16 kg/m².
- Meets the diagnostic criteria for chronic obstructive pulmonary disease (COPD), and has medical records or relevant documentation indicating a...
- Post-bronchodilator ratio of forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) \< 0.7, and post-bronchodilator FEV1 ≥ 30%...
- A current smoker or former smoker with a smoking history of ≥ 10 pack-years, or a history of exposure to other risk factors.
You likely can't join if
- A current diagnosis of asthma or a history of asthma.
- Presence of other significant pulmonary diseases except COPD as judged by the Investigator.
- History of malignancy .
- A history of autoimmune diseases , or treatment with biologics or systemic immunosuppressants for inflammatory diseases within 8 weeks or 5...
- Presence of recurrent, chronic, or other active infections at screening.
- Currently receiving or planning to start long-term oxygen therapy or mechanical ventilation during the study period.
See the full eligibility criteria
- Aged 40 to 85 years (inclusive) at the time of signing the informed consent form, regardless of gender.
- Body Mass Index (BMI) ≥ 16 kg/m².
- Meets the diagnostic criteria for chronic obstructive pulmonary disease (COPD), and has medical records or relevant documentation indicating a history of COPD for ≥ 12 months at screening.
- Post-bronchodilator ratio of forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) \< 0.7, and post-bronchodilator FEV1 ≥ 30% and \< 80% of the predicted value at screening.
- A current smoker or former smoker with a smoking history of ≥ 10 pack-years, or a history of exposure to other risk factors.
- A score of ≥ 2 on the modified Medical Research Council (mMRC) dyspnea scale at screening.
- Medical records or relevant documentation showing ≥ 2 moderate COPD. exacerbations (AECOPD) or ≥ 1 severe AECOPD within the 12 months prior to screening.
- Medical records or relevant documentation showing receipt of background triple therapy (ICS + LABA + LAMA) for ≥ 3 months prior to randomization.
- A blood eosinophil count ≥ 150/mm³ (0.15×10⁹/L) at screening.
- A current diagnosis of asthma or a history of asthma.
- Presence of other significant pulmonary diseases except COPD as judged by the Investigator.
- History of malignancy .
- A history of autoimmune diseases , or treatment with biologics or systemic immunosuppressants for inflammatory diseases within 8 weeks or 5 half-lives (whichever is longer) prior to signing the informed consent form.
- Presence of recurrent, chronic, or other active infections at screening.
- Currently receiving or planning to start long-term oxygen therapy or mechanical ventilation during the study period.
- Diagnosis of α1-antitrypsin deficiency.
- Active hepatitis B, active hepatitis C, positive human immunodeficiency virus (HIV) antibody, or positive Treponema pallidum antibody (TP-Ab).
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Suzhou, Anhui, China
- Chongqing, Chongqing Municipality, China
- Xiamen, Fujian, China
- Guangzhou, Guangdong, China
- Huizhou, Guangdong, China
- Jiangmen, Guangdong, China
- Qingyuan, Guangdong, China
- Nanning, Guangxi, China
- Yulin, Guangxi, China
- Zunyi, Guizhou, China
- Anyang, Henan, China
- Jiaozuo, Henan, China
- Nanyang, Henan, China
- Sanmenxia, Henan, China
- Xinxiang, Henan, China
- Yichang, Hubei, China
- Loudi, Hunan, China
- Hohhot, Inner Mongolia, China
- Lianyungang, Jiangsu, China
+ 18 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Suzhou, Anhui, China; Chongqing, Chongqing Municipality, China; Xiamen, Fujian, China; Guangzhou, Guangdong, China; Huizhou, Guangdong, China and 32 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.