Solrikitug for COPD

(ZION Trial)

Recruiting at 48 trial locations

Overseen By Anushri Walsh

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Uniquity One (UNI)

Must be taking: Inhaled maintenance medications

Disqualifiers: Pregnancy, Cardiovascular, Major disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

171 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it requires that you have been on 2 or more inhaled maintenance medications for at least 3 months before screening. It seems likely you will continue your current medications during the trial.

What data supports the effectiveness of the drug Solrikitug for COPD?

While there is no direct data on Solrikitug, similar treatments like mepolizumab, which is also a monoclonal antibody, have shown benefits in reducing exacerbations in COPD patients with high levels of eosinophils (a type of white blood cell involved in inflammation). This suggests that targeting specific inflammatory pathways may be beneficial for certain COPD patients. ^{1 2 3 4 5}

How is the drug Solrikitug different from other COPD treatments?

Solrikitug is unique because it is a humanized monoclonal antibody that targets a specific protein involved in inflammation, which is different from other COPD treatments like roflumilast that work by inhibiting enzymes to reduce inflammation. This targeted approach may offer a new way to manage COPD symptoms by directly interfering with the inflammatory process. ^{6 7 8 9 10}

Research Team

Andrew W Lee, MD

Principal Investigator

Vice President, Clinical Research

Eligibility Criteria

This trial is for adults aged 40-70 with COPD who experience symptoms (CAT Score ≥10), have been diagnosed for at least a year, and are on two or more inhaled meds. They must have certain levels of lung function and blood eosinophils as per GOLD Guidelines.

Inclusion Criteria

I am between 40 and 70 years old.

I have symptoms of COPD with a CAT score of 10 or more.

I have been on 2 or more inhaled meds for COPD for at least 3 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive solrikitug or placebo via subcutaneous injection over a 12-week period

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

Treatment Details

Interventions

• Solrikitug

Trial Overview The study tests Solrikitug's safety and effects in different doses compared to a placebo in people with COPD. It's randomized, meaning participants are put into groups by chance, double-blind so neither they nor the researchers know who gets what treatment until after the study.

Participant Groups

Group I: Placebo Experimental Treatment 1 Intervention

Placebo

Group II: Biological: Solrikitug Low Dose Experimental Treatment 1 Intervention

Solrikitug

Group III: Biological: Solrikitug High Dose Experimental Treatment 1 Intervention

Solrikitug

Who Is Running the Clinical Trial?

Uniquity One (UNI)

Lead Sponsor

Trials

5

Recruited

490+

DevPro Biopharma

Collaborator

Trials

5

Recruited

800+

DevPro Biopharma

Industry Sponsor

Trials

5

Recruited

800+

Findings from Research

The anti-IL-17A monoclonal antibody CNTO 6785 did not show a statistically significant improvement in lung function for patients with moderate-to-severe COPD compared to placebo, indicating that IL-17A may not be a key factor in COPD pathology.

CNTO 6785 was generally well tolerated with no major safety concerns, and the most common side effects were infections, but these occurred at similar rates in both the treatment and placebo groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized, Placebo-Controlled Phase 2 Trial of CNTO 6785 in Chronic Obstructive Pulmonary Disease. Eich, A., Urban, V., Jutel, M., et al.[2018]

Monoclonal antibody (mAB) therapies have a moderate effect on reducing the risk of exacerbations in chronic obstructive pulmonary disease (COPD), but they do not significantly improve lung function (FEV1) or quality of life (SGRQ).

In eosinophilic COPD patients, the IL-5 antagonist mepolizumab was found to reduce exacerbation risk, while benralizumab showed effectiveness in improving both lung function and quality of life, highlighting the potential of targeting IL-5 pathways in specific patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging biological therapies for treating chronic obstructive pulmonary disease: A pairwise and network meta-analysis. Rogliani, P., Matera, MG., Puxeddu, E., et al.[2019]

In a phase 2a trial involving patients with moderate-to-very severe COPD, astegolimab did not significantly reduce the rate of exacerbations compared to placebo, indicating limited efficacy in preventing acute worsening of the disease.

However, astegolimab was associated with improved health status as measured by the Saint George's Respiratory Questionnaire, suggesting potential benefits in quality of life despite not affecting exacerbation rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Astegolimab, an anti-ST2, in chronic obstructive pulmonary disease (COPD-ST2OP): a phase 2a, placebo-controlled trial. Yousuf, AJ., Mohammed, S., Carr, L., et al.[2023]

A subset of patients with chronic obstructive pulmonary disease (COPD) who have elevated blood eosinophils may benefit from biologic treatments like mepolizumab, which targets eosinophilic inflammation.

Mepolizumab, a monoclonal antibody against interleukin-5 (IL-5), has shown potential therapeutic effects in these patients, particularly in those who do not respond adequately to standard inhaled corticosteroids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mepolizumab in the treatment of eosinophilic chronic obstructive pulmonary disease. Mkorombindo, T., Dransfield, MT.[2020]

In two phase 3 trials involving patients with chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype, mepolizumab (100 mg) significantly reduced the annual rate of moderate or severe exacerbations compared to placebo, particularly in patients with higher blood eosinophil counts.

The safety profile of mepolizumab was comparable to that of placebo, indicating that it is a safe treatment option for reducing exacerbations in this specific patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mepolizumab for Eosinophilic Chronic Obstructive Pulmonary Disease. Pavord, ID., Chanez, P., Criner, GJ., et al.[2022]

In a study involving 109 patients with stable COPD, a fully human monoclonal antibody targeting interleukin-8 showed a significant improvement in dyspnea (difficulty breathing) compared to placebo, particularly noted at week 2.

While the monoclonal antibody improved dyspnea scores, it did not show significant differences in lung function or other health measures, indicating that while it may help with symptoms, further research is needed to understand its overall impact on COPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of a monoclonal antibody recognizing interleukin-8 in COPD: a pilot study. Mahler, DA., Huang, S., Tabrizi, M., et al.[2019]

Roflumilast, a phosphodiesterase-4 inhibitor, significantly improved lung function in COPD patients, with an increase in forced expiratory volume (FEV1) of 36-88 mL compared to placebo, based on data from 6 clinical trials.

While roflumilast reduced exacerbation rates in some patients with chronic cough and a history of exacerbations, it also had common adverse effects, leading to discontinuation in 9% to 16% of patients, including gastrointestinal issues and headaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Roflumilast: a phosphodiesterase-4 inhibitor for the treatment of severe chronic obstructive pulmonary disease. Pinner, NA., Hamilton, LA., Hughes, A.[2022]

Roflumilast, an oral PDE4 inhibitor, effectively reduces airway inflammation in patients with severe and symptomatic COPD, leading to fewer exacerbations and modest improvements in lung function (FEV1).

The most common side effects of roflumilast include gastrointestinal issues like diarrhea and nausea, but it is generally well-tolerated and can be used alongside long-acting bronchodilators for better management of COPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Roflumilast: clinical benefit in patients suffering from COPD. Ulrik, CS., Calverley, PM.[2012]

Roflumilast, when combined with inhaled corticosteroids and long-acting β2 agonists, significantly improves lung function in severe COPD patients, as shown by increased forced expiratory volume (FEV1) and reduced exacerbation rates in a meta-analysis of 9,715 patients.

While roflumilast is effective, it is associated with a higher incidence of adverse effects such as diarrhea, headache, and nausea compared to placebo, indicating the need for careful monitoring of side effects in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Roflumilast on Patients with Chronic Obstructive Pulmonary Disease Treated with Inhaled Corticosteroid/Long-Acting β2 Agonist: A Meta-analysis. Zeng, S., Bai, H., Zou, M.[2022]

Roflumilast is the first drug specifically developed for treating a particular phenotype of COPD, particularly in patients with chronic bronchitis, highlighting its targeted therapeutic approach.

In preclinical studies, roflumilast demonstrated strong anti-inflammatory effects against various cells and mediators involved in COPD, suggesting its potential efficacy in managing the disease's underlying mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Phosphodiesterase-4 inhibitors: roflumilast]. Izquierdo Alonso, JL.[2015]

References

1. England pubmed.ncbi.nlm.nih.gov

A Randomized, Placebo-Controlled Phase 2 Trial of CNTO 6785 in Chronic Obstructive Pulmonary Disease. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Emerging biological therapies for treating chronic obstructive pulmonary disease: A pairwise and network meta-analysis. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Astegolimab, an anti-ST2, in chronic obstructive pulmonary disease (COPD-ST2OP): a phase 2a, placebo-controlled trial. [2023]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Mepolizumab in the treatment of eosinophilic chronic obstructive pulmonary disease. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Mepolizumab for Eosinophilic Chronic Obstructive Pulmonary Disease. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of a monoclonal antibody recognizing interleukin-8 in COPD: a pilot study. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Roflumilast: a phosphodiesterase-4 inhibitor for the treatment of severe chronic obstructive pulmonary disease. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Roflumilast: clinical benefit in patients suffering from COPD. [2012]

9. United States pubmed.ncbi.nlm.nih.gov

Effects of Roflumilast on Patients with Chronic Obstructive Pulmonary Disease Treated with Inhaled Corticosteroid/Long-Acting β2 Agonist: A Meta-analysis. [2022]

10. Spain pubmed.ncbi.nlm.nih.gov

[Phosphodiesterase-4 inhibitors: roflumilast]. [2015]