ZL-1102 Gel for Psoriasis

Recruiting at 22 trial locations

Overseen By Zai Lab 1102-002 Study Team

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Zai Lab (Hong Kong), Ltd.

Disqualifiers: HIV, Hepatitis B, Hepatitis C, others

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

Compensation: Varies

Number of Visits: 2

Duration: 16 weeks

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new topical gel, ZL-1102, for individuals with chronic plaque psoriasis, a skin condition that causes red, scaly patches. The research aims to determine the safety and effectiveness of different doses of this gel in treating the condition. Participants will receive either the active gel or a placebo (an inactive substance) to compare results. Individuals with psoriasis vulgaris for at least six months, who currently manage it with topical treatments and have noticeable patches on 3%-15% of their body, may be suitable for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants the chance to contribute to the development of a potentially effective new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that ZL-1102 gel is likely to be safe for humans?

Research has shown that ZL-1102, a gel applied to the skin for treating psoriasis, has promising safety results from earlier studies. Safety data from 53 patients indicate that the gel is as safe as a placebo, meaning it is generally well-tolerated. Reports of side effects related to the treatment were low, suggesting that patients managed the treatment well. So far, the gel appears safe with minimal side effects, making it a potential option for those considering participation in a clinical trial for psoriasis treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for psoriasis?

Unlike the standard psoriasis treatments, which often involve systemic medications or topical steroids, ZL-1102 is a topical gel that uses a unique mechanism of action. This gel is designed to target specific inflammatory pathways directly in the skin, potentially reducing side effects associated with more generalized treatments. Researchers are excited because ZL-1102 could offer a more targeted approach, providing effective relief from symptoms with potentially fewer side effects. Additionally, the convenience of a topical application makes it an appealing option for patients seeking easier management of their condition.

What evidence suggests that ZL-1102 gel might be an effective treatment for psoriasis?

Previous studies have shown that ZL-1102, a topical gel, holds promise for treating chronic plaque psoriasis. This treatment stands out as the first topical biologic capable of effectively reaching and improving psoriatic skin. Research indicates that patients using ZL-1102 experienced about a 45% improvement in their Psoriasis Area Severity Index (PASI), which measures the severity and extent of psoriasis. Specifically, the gel significantly reduced symptoms compared to a placebo. Overall, these findings suggest ZL-1102 could be a strong option for managing psoriasis symptoms. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for individuals with chronic plaque psoriasis. Participants should have a stable disease state and be willing to apply the study gel as directed throughout the trial period. Specific details about who can join are not provided, but typically participants must meet certain health criteria.

Inclusion Criteria

Willing and able to provide signed and dated informed consent prior to any study-related procedures, and willing and able to comply with all study procedures

I have had psoriasis for at least 6 months and qualify for topical treatment.

Exclusion Criteria

Positive for any of the following tests at screening: Human immunodeficiency virus (HIV): HIV antibody, Hepatitis B virus (HBV): hepatitis B surface antigen (HBsAg)/hepatitis B core antibody (HBcAb)/HBV DNA, Hepatitis C virus (HCV): HCV RNA, Patients with active tuberculosis (TB) or untreated latent TB per local guidelines, History of and/or concurrent condition of inflammatory bowel disease (IBD) (ulcerative colitis and Crohn's disease), or signs/symptoms of IBD at screening that, in the opinion of the Investigator, pose an unacceptable risk to the patient if participating in the study, History of and/or concurrent condition of serious hypersensitivity (anaphylactic shock or anaphylactoid reaction) to IL-17 antibodies and any human or humanized biological agents, Patients who have a history of malignancy unless deemed cured by adequate treatment with no evidence of recurrence for ≥ 3 years before the initiation of study treatment, Patients with a history of chronic alcohol or drug abuse within 6 months of the initiation of study treatment, as determined by the Investigator, Prior exposure to ZL-1102, Patients who have received a live vaccine within 6 weeks prior to dosing on Day 1, Females who are pregnant, wishing to become pregnant during the study, or are breastfeeding

Patients with any serious medical/psychiatric condition or clinically significant laboratory abnormality that would prevent study participation or place the patient at significant risk, as determined by the Investigator

My psoriasis is not mainly plaque type or can't be treated with just creams.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ZL-1102 or vehicle for 16 weeks in a randomized, double-blind, vehicle-controlled, dose-ranging study

16 weeks

Multiple visits as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of mPASI and IGA scores

4 weeks

Visits at Weeks 2, 4, 8, 12, 16, and 20

What Are the Treatments Tested in This Trial?

Interventions

• ZL-1102

Trial Overview The study is testing ZL-1102, a topical gel designed to treat plaque psoriasis by targeting IL-17A, which is involved in inflammation. Patients will be randomly assigned to receive different doses of ZL-1102 or a placebo without knowing which one they're getting.

How Is the Trial Designed?

Group I: Arm 1 Active Control 1 Intervention

ZL-1102

Group II: Arm 2 Active Control 1 Intervention

ZL-1102

Group III: Arm 3 Active Control 1 Intervention

ZL-1102

Group IV: Arm 4 Placebo Group 1 Intervention

Vehicle

Group V: Arm 5 Placebo Group 1 Intervention

Vehicle

Who Is Running the Clinical Trial?

Zai Lab (Hong Kong), Ltd.

Lead Sponsor

Trials

4

Recruited

430+

Zai Lab (US) LLC

Industry Sponsor

Trials

3

Recruited

450+

Published Research Related to This Trial

Zoledronic acid (ZA), commonly used for treating postmenopausal osteoporosis, has been associated with rare cutaneous side effects, including a newly reported case of interface dermatitis in a 62-year-old woman shortly after infusion.

This case highlights the need for awareness of potential skin reactions to ZA, as it is the first documented instance of interface dermatitis linked to this medication, although further follow-up is necessary to rule out other connective tissue diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zoledronic Acid-Induced Interface Dermatitis. Succaria, F., Collier, M., Mahalingam, M.[2018]

Zoledronic acid (Zol) effectively stimulates gammadelta T cells, leading to their proliferation in 100% of normal donors and 50% of multiple myeloma (MM) patients, indicating its potential as an immunomodulatory treatment.

Zol enhances the antimyeloma activity of gammadelta T cells by activating them through monocytes and increasing the sensitivity of myeloma cells, although this effect can be completely blocked by mevastatin, suggesting a specific mechanism of action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effector gammadelta T cells and tumor cells as immune targets of zoledronic acid in multiple myeloma. Mariani, S., Muraro, M., Pantaleoni, F., et al.[2021]

In a study of 10 postmenopausal women with inflammatory rheumatic diseases, intravenous zoledronate (ZOL) induced an acute phase response (APR) characterized by changes in blood cell counts and a significant decrease in soluble CTLA-4 levels, suggesting an immunomodulatory effect of ZOL.

ZOL treatment not only reduced soluble CTLA-4 levels in patients but also inhibited its production and expression in vitro, indicating that ZOL may have important effects on immune regulation beyond its known role in bone resorption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zoledronate decreases CTLA-4 in vivo and in vitro independently of its action on bone resorption. Giusti, A., Camellino, D., Saverino, D., et al.[2021]

Zoledronic acid (ZOL) significantly prolonged the survival of skin allografts in a mouse model, indicating its potential as a treatment to reduce acute rejection in transplant scenarios.

The treatment with ZOL showed no major toxicity, as there were no significant differences in body weight, leukocyte count, or liver and kidney function between ZOL-treated and control groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zoledronic acid, an aminobisphosphonate, prolongs survival of skin allografts. Liu, CY., Yang, PS., Cheng, SP., et al.[2019]

This case report describes the first instance of zoledronic acid-induced uveitis with macular edema occurring after a patient had tolerated long-term oral alendronate, suggesting that prior tolerance to one bisphosphonate does not guarantee safety with another.

The treatment for zoledronic acid-induced uveitis typically requires steroids, and rechallenging with bisphosphonates may not be contraindicated, as evidenced by cases where no additional uveitis occurred after rechallenge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute bilateral uveitis and right macular edema induced by a single infusion of zoledronic acid for the treatment of postmenopausal osteoporosis as a substitution for oral alendronate: a case report. Tian, Y., Wang, R., Liu, L., et al.[2018]

Citations

1. zailab.gcs-web.com zailab.gcs-web.com/news-releases/news-release-details/zai-lab-initiates-global-phase-2-clinical-trial-evaluating-zl

Zai Lab Initiates Global Phase 2 Clinical Trial Evaluating ZL ... Based on a proof-of-concept study, ZL-1102 is the first topical biologic to show penetration of psoriatic skin resulting in a clinical response.

2. ir.zailaboratory.com ir.zailaboratory.com/news-releases/news-release-details/zl-1102-zai-labs-internally-developed-novel-human-vh-antibody

ZL-1102, Zai Lab's Internally Developed Novel Human VH ... Treatment with ZL-1102 showed approximately a 45% relative improvement compared to placebo in the local Psoriasis Area Severity Index (PASI)1 ...

3. dermatologytimes.com dermatologytimes.com/view/phase-2-trial-of-zl-1102-for-psoriasis-begins

Phase 2 Trial of ZL-1102 for Psoriasis Begins Ina proof-of-concept study, Zai Lab previously reported data showing a 45% relative improvement for those treated with ZL-1102 compared to ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06380907

NCT06380907 | A Phase 2 Study of ZL-1102 in Patients ... This is a randomized, double-blind, vehicle-controlled, dose-ranging, phase 2 study of ZL-1102 in patients with chronic plaque psoriasis. Approximately 250 ...

5. clinicaltrialsarena.com clinicaltrialsarena.com/news/zai-lab-psoriasis-therapy-trial/

Zai Lab reports positive data from Phase Ib psoriasis ... According to the efficacy results from 51 evaluable subjects, ZL-1102 demonstrated to offer nearly a 45% relative improvement in the local PASI ...