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

Trial Summary

What is the purpose of this trial?

A Randomized, Double-Blind, Vehicle-Controlled, Multicenter, Dose-Ranging, Phase 2 Study to Evaluate the Efficacy and Safety of Different Doses of ZL-1102 Topical gel (A Human VH IL-17A Antibody Fragment) in the Treatment of Chronic Plaque Psoriasis

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.

What makes the drug ZL-1102 Gel unique for treating psoriasis?

ZL-1102 Gel is unique for treating psoriasis because it is a topical treatment, which means it is applied directly to the skin, potentially offering a more targeted approach with fewer systemic side effects compared to oral or injectable medications. ^{1 2 3 4 5}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Zoledronic acid, an aminobisphosphonate, prolongs survival of skin allografts. [2019]

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

Zoledronic Acid-Induced Interface Dermatitis. [2018]

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

Effector gammadelta T cells and tumor cells as immune targets of zoledronic acid in multiple myeloma. [2021]

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

Zoledronate decreases CTLA-4 in vivo and in vitro independently of its action on bone resorption. [2021]

5. England 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. [2018]