ZL-1102 Gel for Psoriasis
Recruiting in Palo Alto (17 mi)
+22 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Zai Lab (Hong Kong), Ltd.
Disqualifiers: HIV, Hepatitis B, Hepatitis C, others
Prior Safety Data
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.
12345Eligibility 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
I am 18 years old or older.
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.
+1 more
Trial 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
Participant Groups
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.
5Treatment groups
Active Control
Placebo Group
Group I: Arm 1Active Control1 Intervention
ZL-1102
Group II: Arm 2Active Control1 Intervention
ZL-1102
Group III: Arm 3Active Control1 Intervention
ZL-1102
Group IV: Arm 4Placebo Group1 Intervention
Vehicle
Group V: Arm 5Placebo Group1 Intervention
Vehicle
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Zai Lab Site 7009Barrie, Canada
Zai Lab Site 7001Toronto, Canada
Zai Lab Site 7017Fredericton, Canada
Zai Lab Site 7005Ottawa, Canada
More Trial Locations
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Who Is Running the Clinical Trial?
Zai Lab (Hong Kong), Ltd.Lead Sponsor
Zai Lab (US) LLCIndustry Sponsor
References
Zoledronic acid, an aminobisphosphonate, prolongs survival of skin allografts. [2019]Zoledronic acid (ZOL), an effective nitrogen-containing bisphosphonate used to prevent excessive bone loss in clinical practice, has been shown to affect the development of dendritic cells by redirecting differentiation toward a state of atypical maturation. The study was aimed to examine whether ZOL can reduce acute rejection of skin allografts.
Zoledronic Acid-Induced Interface Dermatitis. [2018]Zoledronic acid (ZA) is a bisphosphonate given intravenously, most commonly for the treatment of postmenopausal osteoporosis. Increase in usage of ZA because it was FDA-approved has resulted in increasing reports of side effects. For the most part, these are systemic. Cutaneous side effects associated with ZA are infrequent and limited to 2 reports of dermatomyositis to date. In both, patients presented with clinical and laboratory stigmata of dermatomyositis soon after initiation of therapy. In this report, we describe a 62-year-old woman who presented with diffuse, erythematous scaly plaques over the right thigh after 12 hours of infusion of ZA. Histopathologic examination of a skin biopsy from the right thigh revealed patchy scale crust containing neutrophils and inspissated serum, interface change with scattered individually necrotic keratinocytes, and a mild, superficial perivascular lymphocytic infiltrate with scattered eosinophils and pigment incontinence-findings consistent with an interface dermatitis. Given that the patient had no other systemic manifestations or laboratory abnormalities, to the best of our knowledge, ours is the first report of interface dermatitis secondary to ZA with the caveat that longer follow-up is required to definitively exclude the development of drug-induced connective tissue disease.
Effector gammadelta T cells and tumor cells as immune targets of zoledronic acid in multiple myeloma. [2021]The aim of this study was to investigate the in vitro immunomodulatory effects of zoledronic acid (Zol) on peripheral blood Vgamma9/Vdelta2 (gammadelta) T cells of normal donors and multiple myeloma (MM) patients. gammadelta T cells were stimulated with Zol and low doses of interleukin-2 (IL-2), and then analyzed for proliferation, cytokine production, and generation of effector activity against myeloma cell lines and primary myeloma cells. Proliferation of gammadelta T cells was observed in 100% of normal donors and 50% of MM patients. gammadelta T cells produced IFN-gamma, surface mobilized the CD107a and CD107b antigens, and exerted direct cell-to-cell antimyeloma activity irrespective of the ability to proliferate to Zol and IL-2. The memory phenotype was predominant in the MM gammadelta T cells that proliferated in response to Zol (responders), whereas effector cells were predominant in those that did not (nonresponders). Zol induced antimyeloma activity through the monocyte-dependent activation of gammadelta T cells and by enhancing the immunosensitivity of myeloma cells to gammadelta T cells. Mevastatin, a specific inhibitor of hydroxy-methylglutaryl-CoA reductase, completely abrogated this antimyeloma activity.
Zoledronate decreases CTLA-4 in vivo and in vitro independently of its action on bone resorption. [2021]Acute phase response (APR) following intravenous zoledronate (ZOL) administration is related to activation and increased proliferation of γδ T cells, attributed to the molecular mechanism of action of nitrogen-containing bisphosphonates (N-BPs). ZOL, however, has also been reported to inhibit the proliferation of regulatory T cells in vitro and to reduce the expression of Cytotoxic T-Lymphocyte Antigen-4 (CTLA-4), a negative regulator of T cell activation that is increased in patients with autoimmune diseases. There are, however, no data on the relationship between ZOL treatment and soluble(s)CTLA-4 either in vivo in relevant patient populations or in vitro with the use of assays relevant to the mechanism of action of N-BPs. The objectives of the present study were firstly, to characterize the ZOL-induced APR in patients with inflammatory rheumatic diseases (IRDs) and its relationship with changes in circulating sCTLA-4 and secondly, to investigate the effects of ZOL on CTLA-4 production and expression by peripheral blood mononuclear cells (PBMCs). We studied 10 postmenopausal women with IRDs treated with intravenous ZOL 5 mg. Five women experienced APR (APR+) associated with significant decreases in blood lymphocytes and increases in granulocytes and serum CRP. Serum sCTLA-4 values were increased in all patients before ZOL administration and decreased significantly 72 h after the ZOL infusion (from 30.0 ± 2.9 to 6.3 ± 1.8 ng/ml; p
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]Zoledronic acid-induced uveitis (ZAIU) is rare but severe, and has been recently considered part of an acute phase reaction. Only 15 cases have been reported since 2005. Here we describe a case with macular edema, which is the first reported case observed after long-term alendronate tolerance.