CGB-500 Ointment for Eczema

Recruiting at 16 trial locations

Overseen By Nitin Joshi, Ph.D.

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: CAGE Bio Inc.

Must not be taking: JAK inhibitors, CYP3A4 inhibitors

Disqualifiers: Pregnancy, Immunocompromised, Skin infections, others

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

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new ointment, CGB-500, to determine its effectiveness for atopic dermatitis, commonly known as eczema. Researchers aim to discover if CGB-500 can reduce the area and severity of eczema patches and ensure its safety. Participants will apply either the CGB-500 ointment or a placebo daily for 8 weeks, tracking symptoms such as itching. This trial suits individuals who have had eczema for at least a year, with noticeable patches covering 1% to 10% of their skin, and who experience frequent itching. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires participants to stop certain medications before starting. You must stop using moderate to strong CYP3A4 and CYP3A5 inhibitors 4 weeks before, topical JAK inhibitors 2 weeks before, and systemic JAK inhibitors 4 weeks before. Other specific medications and treatments also have required stop times before the trial begins.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that CGB-500, a cream containing tofacitinib, is safe for individuals with atopic dermatitis. Studies indicate that the cream remains primarily in the skin, enhancing its effectiveness on the affected area and reducing the risk of side effects elsewhere in the body. Previous trials did not find any unexpected safety issues, which is reassuring. Overall, CGB-500 has met safety standards in past research, suggesting it is safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about CGB-500 ointment for eczema because it introduces tofacitinib, a JAK inhibitor, directly into an ointment form. Unlike traditional treatments like topical corticosteroids or calcineurin inhibitors, tofacitinib works by specifically targeting and blocking certain enzymes involved in the inflammatory process, which may lead to reduced inflammation and itchiness. This trial explores two concentrations, 0.5% and 1% tofacitinib, which could potentially offer more customized and effective treatment options. The ointment form provides a direct application to the affected area, which might enhance its effectiveness and reduce systemic side effects, setting it apart from oral or systemic treatments.

What evidence suggests that CGB-500 might be an effective treatment for atopic dermatitis?

Research has shown that CGB-500 ointment may help treat atopic dermatitis, a common type of eczema. In earlier studies, the ointment significantly reduced itching and improved the skin condition of people with moderate to severe atopic dermatitis. About 59% of patients experienced noticeable skin improvement after using CGB-500. It also met safety standards, as it did not cause major side effects for most people. These results suggest that CGB-500 could effectively manage eczema symptoms.

In this trial, participants will receive either CGB-500 ointment with 0.5% tofacitinib, CGB-500 ointment with 1% tofacitinib, or a vehicle ointment as a placebo comparator. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for individuals aged 12 and older with atopic dermatitis, including conditions like perianal dermatitis and eczema. Participants will use the treatment daily for 8 weeks and visit the clinic regularly. The eligibility criteria are not fully listed here.

Inclusion Criteria

Have an IGA (Investigator's Global Assessment) score of 2, 3, or 4 at Screening and Baseline

In general, good health as determined by medical history and physical examination at the time of screening (investigator discretion)

My itchiness level is 4 or higher on a scale of 0 to 10.

Exclusion Criteria

Medical or psychiatric conditions, or a personal situation, that may increase the risk associated with trial participation or may interfere with interpretation of trial results or participant compliance and, in the opinion of the PI, makes the participant inappropriate for trial entry

Immunocompromised individuals as adjudicated by the principal investigator (PI) based on review of medical history

Has clinically significant safety labs (hematology, chemistry, and urinalysis) at the Screening visit that, in the opinion of the investigator, would preclude participation in the study or affect proper assessment of the study endpoints

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

Participants receive CGB-500 or placebo daily for 8 weeks, with clinic visits every 2 weeks for the first month and at the end of 8 weeks

8 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CGB-500

Trial Overview The study tests CGB-500 ointment containing either 0.5% or 1% tofacitinib against a placebo to see if it improves skin affected by atopic dermatitis. It measures the change in area and severity of lesions over an eight-week period.

How Is the Trial Designed?

Group I: CGB 500 ointment with 1% tofacitinib Experimental Treatment 1 Intervention

Group II: CGB 500 ointment with 0.5% tofacitinib Experimental Treatment 1 Intervention

Group III: vehicle ointment Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

CAGE Bio Inc.

Lead Sponsor

Trials

8

Recruited

430+

Published Research Related to This Trial

A study involving 46 patients with chronic atopic eczema found that a topical cream containing 4% sodium cromoglycate (SCG) significantly improved symptoms after 9 weeks compared to a placebo, particularly in mild to moderate cases.

Despite the improvement, SCG showed limited effectiveness in severe eczema, possibly due to its delayed onset of action and low absorption, with bioavailability ranging from 0.01% to 2.75%, suggesting it may be more suitable for managing mild or moderate eczema over the long term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical sodium cromoglycate in the management of atopic eczema--a controlled trial. Ariyanayagam, M., Barlow, TJ., Graham, P., et al.[2019]

Narrowband ultraviolet B (NB-UVB) treatment resulted in a 61% reduction in eczema severity (measured by the SASSAD score) in 29 children, compared to a 6% increase in severity in a control group of 26 children who did not receive treatment.

The benefits of NB-UVB treatment not only improved objective eczema scores but also significantly enhanced quality of life, with effects lasting for at least 6 months post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Narrowband ultraviolet B phototherapy in children with moderate-to-severe eczema: a comparative cohort study. Darné, S., Leech, SN., Taylor, AE.[2022]

In a study involving 100 patients with eczema/atopic dermatitis, clocortolone pivalate 0.1% cream was found to be significantly more effective than a placebo in all measured outcomes, both objective and subjective.

The treatment was well-tolerated with no adverse reactions reported, indicating a high level of safety and excellent patient acceptance for both the active and placebo creams.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clocortolone pivalate: a paired comparison clinical trial of a new topical steroid in eczema/atopic dermatitis. Rosenthal, AL.[2019]

CTGO contains 29 identified compounds and has been shown to significantly improve skin conditions in eczema-affected rats by modulating key inflammatory markers and pathways.

The treatment appears to work primarily through the TLR4/NF-κB signaling pathway, suggesting a specific mechanism of action that could guide future research and development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated strategy of network analysis prediction and experimental validation to elucidate the possible mechanism of compound Turkish gall ointment in treating eczema. Ma, X., Hao, M., Zhang, MH., et al.[2022]

In a trial with 42 children suffering from chronic atopic eczema, those treated with a 10% sodium cromoglycate ointment showed significant improvements in skin inflammation and symptoms compared to a placebo, with only 4 withdrawals due to ineffectiveness versus 16 in the placebo group.

No side effects were reported, suggesting that sodium cromoglycate ointment could be a safe alternative to topical steroids for treating atopic eczema in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of atopic eczema in children: clinical trial of 10% sodium cromoglycate ointment. Haider, SA.[2019]

Wenguanmu ointment, a traditional Mongolian medicine, effectively treats eczema in mice by reducing inflammation, pain, and itching, as evidenced by decreased levels of pro-inflammatory cytokines and immunoglobulin E.

The ointment's therapeutic effects are linked to the inhibition of the CKLF-1/NF-κB signaling pathway, suggesting a specific mechanism of action that contributes to its efficacy in alleviating eczema symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mongolian medicine Wenguanmu ointment treats eczema by inhibiting the CKLF-1/NF-κB pathway. Zhu, L., Li, XJ., Gu, C., et al.[2023]

In a phase 3 trial involving 211 patients with moderate-to-severe atopic dermatitis, lebrikizumab (LEB) combined with topical corticosteroids (TCS) significantly improved skin condition, with 41.2% of patients achieving a clear or almost clear skin score compared to 22.1% in the placebo group.

The safety profile of LEB was consistent with previous studies, with most adverse events being mild or moderate, and serious adverse events were similarly low in both the LEB and placebo groups, indicating that LEB is a safe and effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Lebrikizumab in Combination With Topical Corticosteroids in Adolescents and Adults With Moderate-to-Severe Atopic Dermatitis: A Randomized Clinical Trial (ADhere). Simpson, EL., Gooderham, M., Wollenberg, A., et al.[2023]

In an open trial with 247 eczema patients, Sicorten topicals showed excellent results, with 90% to 100% effectiveness across different types of dermatitis, including atopic and contact dermatitis.

A double-blind trial with 108 patients indicated that Sicorten's effectiveness was comparable to Betnelan, suggesting that Sicorten is a safe and effective treatment option for various forms of dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sicorten: a synthetic corticosteroid for topical treatment of common dermatoses. Majerus, JP., Reiffers-Mettelock, J.[2013]

There is currently limited evidence for effective treatments for chronic nodular prurigo (CNPG), as the systematic review found only three randomized controlled trials and six case studies with more than 15 patients, making it difficult to draw strong conclusions.

Ongoing and upcoming randomized controlled trials on new therapies may provide better treatment options for CNPG patients in the future, as existing therapies have shown heterogeneous results and lack targeted approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-Atopic Chronic Nodular Prurigo (Prurigo Nodularis Hyde): A Systematic Review of Best-Evidenced Treatment Options. Frølunde, AS., Wiis, MAK., Ben Abdallah, H., et al.[2022]

In a 12-week study involving 208 children with atopic dermatitis, a 4% sodium cromoglicate (SCG) emulsion significantly reduced the SCORAD score by 28% compared to a 19% reduction in the vehicle group, indicating its efficacy in treating the condition.

The SCG treatment also led to a significant reduction in the use of topical steroids, with 35% less usage in the SCG group, and was well-tolerated, with only 12.5% of subjects reporting discomfort at the application site.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised, controlled trial of a 4% cutaneous emulsion of sodium cromoglicate in treatment of atopic dermatitis in children. Berth-Jones, J., Pollock, I., Hearn, RM., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06923228

A Study to Assess Efficacy and Safety of CGB-500, 1% ... The goal of this clinical trial is to learn if drug CGB-500 works to treat atopic dermatitis in subjects 12 years of age or older.

2. dermatologytimes.com dermatologytimes.com/view/cage-bio-reports-strong-phase-2b-results-for-cgb-500-in-ad

CAGE Bio Reports Strong Phase 2b Results for CGB-500 ... CGB-500 demonstrated significant efficacy and rapid itch relief in moderate to severe atopic dermatitis with less than 10% body surface area ...

3. biospace.com biospace.com/press-releases/cage-bio-reports-strong-results-from-its-phase-2b-atopic-dermatitis-trial

CAGE Bio Reports Strong Results from its Phase 2b Atopic ... The investigational topical drug CGB-500 outperformed efficacy benchmarks while meeting safety endpoints · 59% of patients achieved IGA treatment ...

4. thedermdigest.com thedermdigest.com/ad-pipeline-watch-cage-bios-topical-cgb-500-helps-patients-ditch-itch-early/

AD Pipeline Watch: CAGE Bio's Topical CGB-500 Helps ... CAGE Bio's investigational atopic dermatitis (AD) drug CGB-500 outperformed efficacy benchmarks while meeting safety endpoints, according to topline results ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06810050/phase-2b-safety-and-efficacy-study-of-cgb-500-topical-ointment-with-05-and-1-tofacitnib-for-treatment-of-atopic-dermatitis

Phase 2b Safety and Efficacy Study of CGB-500 Topical ... The goal of this clinical trial is to learn if CGB-500 works to treat atopic dermatitis in participants ages 12 and older.

6. dermatologytimes.com dermatologytimes.com/view/an-inside-look-in-the-development-of-cgb-500-for-atopic-dermatitis-treatment

An Inside Look in the Development of CGB-500 For Atopic ... We get 20 times higher exposure in the skin where the drug needs to be and five to seven times lower exposure in systemic circulation," Joshi ...