The Efficacy and Safety of TLL018 in Moderate-to-severe Plaque Psoriasis

Plaque Psoriasis Clinical Trial

Official title:

A Randomized, Double-blinded, Placebo-controlled, Multicenter Phase 2 Study Evaluating the Efficacy and Safety of TLL018 in Participants With Moderate-to-severe Plaque Psoriasis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05772520
• Other study ID #: TLL018-205
• Status: Recruiting
• Phase: Phase 2
• Start date: January 19, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: September 2023
• Source: Hangzhou Highlightll Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 2, multicenter, randomized, double-blinded, parallel dose group, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of 3 doses of TLL018 as therapy in 120 participants with moderate-to-severe PP.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 31, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Are between the ages of 18 and 75 years, inclusive, at time of informed consent.

2. Capable of giving informed consent and complying with study procedures.

3. Willing and able to adhere to study restrictions.

4. Laboratory and medical history parameters within the protocol defined ranges.

5. Body mass index (BMI) of 18.0 to 35.0 kg/m2inclusive.

6. Have had a diagnosis of moderate-to-severe PP for at least 6 months prior to Baseline.

7. Participants with moderate-to-severe PP covering =10% body surface area (BSA), with a Psoriasis Area and Severity Index (PASI) =12 and a static Physician's Global Assessment (PGA) score =3 at Baseline.

...

Exclusion Criteria:

1. Pregnant or nursing women.

2. History of chronic alcohol or drug abuse within 6 months prior to Screening as determined by the Investigator based on medical history and patient interview

3. Current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, neurologic, or psychiatric disease.

4. Current and/or recent history (<30 days prior to Screening and/or <45 days prior to randomization) of a clinically significant viral, bacterial, fungal, parasitic, or mycobacterial infection.

5. Any history of malignancies, except for non-recurrent basal cell skin cancer, squamous cell skin cancer, and cervical cancer in situ that are considered to be cured.

6. Tests positive for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV). Hepatitis B test result positive definition: 1) hepatitis B surface antigen (HBsAg) positive, or 2) Hepatitis B core antibody positive and hepatitis B virus deoxyribonucleic acid positive or beyond the upper limit of normal (ULN) value; positive hepatitis C virus result is defined as having a positive hepatitis C antibody test with a positive confirmatory hepatitis C polymerase chain reaction test.

7. Recent exposure to active tuberculosis (TB). Current evidence of active TB or current evidence of latent TB. Participants with positive TB test (e.g., QuantiFERON) that have been treated for latent TB.

8. Previous or current autoimmune diseases (e.g., RA, systemic lupus erythematosus, IBD, scleroderma, inflammatory myopathy, mixed connective tissue disease overlap syndrome, etc.). Note, psoriatic arthritis patients are allowed.

9. Other types of psoriasis (such as erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, drug-induced psoriasis) ....

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• TLL018 tablets
oral tablets administered BID for 12weeks

Locations

Country	Name	City	State
United States	Derm Research	Austin	Texas
United States	Moy, Fincher, Chipps	Beverly Hills	California
United States	Cahaba	Birmingham	Alabama
United States	Metro Boston	Brighton	Massachusetts
United States	CRCC	Charleston	South Carolina
United States	Remington-Davis, Inc.	Columbus	Ohio
United States	Life Clinical Trials	Coral Springs	Florida
United States	Studies in Dermatology, LLC	Cypress	Texas
United States	Palm Beach	DeLand	Florida
United States	Integrated Clinical Trial Services, Inc	Des Moines	Iowa
United States	D&H Doral Research Center LLC	Doral	Florida
United States	CNS - Jacksonville	Jacksonville	Florida
United States	Altus Research	Lake Worth	Florida
United States	Metropolis Derm	Los Angeles	California
United States	Mount Sinai	New York	New York
United States	AQUA - Riverchase	Pembroke Pines	Florida
United States	Austin Institute for Clinical Research	Pflugerville	Texas
United States	Lawrence Green	Rockville	Maryland
United States	Integrative Skin	Sacramento	California
United States	Progressive Clinical Research Group, Inc.	San Antonio	Texas
United States	Skin Surgical	San Diego	California
United States	Premier Clinical Research	Spokane	Washington
United States	Acclaim	Sugar Land	Texas
United States	DermDox	Sugarloaf	Pennsylvania
United States	Revival Research Institute	Troy	Missouri
United States	Grekin Skin	Warren	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Hangzhou Highlightll Pharmaceutical Co., Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of participants achieving PASI-75	A patient was a responser if a minimum 75% PASI improvement from Baseline was achieved including measure of the average redness (erythema), thickness (induration), and scaliness (scaling); In calculating the PASI, severity is determined by dividing the body into four regions: head (h), upper extremities (u), trunk (t), and lower extremities (l).Each of these areas is assessed separately for erythema, induration, and scaling, which are rated on a scale of 0 (none) to 4 (very severe). Extent of psoriatic involvement is graded as follows: 0 = no involvement; = 1% to 9%; = 10% to 29%; = 30% to 49%; = 50% to 69%; = 70% to 89%; = 90% to 100%. PASI = 0.1 (Eh + lh + Sh) Ah + 0.2 (Eu + lu + Su) Au + 0.3 (Et +lt + St) At + 0.4 (El +ll +Sl) Al	Week12
Secondary	Proportion of participants achieving PGA score of 0 or 1	A patient was a responser if PGA score of 0 or 1 condition was reached, as listed: (0 Clear) No signs of psoriasis, but post-inflammatory discoloration may be present; (1 Almost clear): Only minimal plaque elevation, scaling, and erythema.	From week 4 to Weeks 12
Secondary	Proportion of participants achieving PASI-75 (except Week 12)	A patient was a responser if a minimum 75% PASI improvement from Baseline was achieved including measure of the average redness (erythema), thickness (induration), and scaliness (scaling); In calculating the PASI, severity is determined by dividing the body into four regions: head (h), upper extremities (u), trunk (t), and lower extremities (l).Each of these areas is assessed separately for erythema, induration, and scaling, which are rated on a scale of 0 (none) to 4 (very severe). Extent of psoriatic involvement is graded as follows: 0 = no involvement; = 1% to 9%; = 10% to 29%; = 30% to 49%; = 50% to 69%; = 70% to 89%; = 90% to 100%. PASI = 0.1 (Eh + lh + Sh) Ah + 0.2 (Eu + lu + Su) Au + 0.3 (Et +lt + St) At + 0.4 (El +ll +Sl) Al	From week 4 to Weeks 12(except Week 12)
Secondary	Proportion of participants achieving PASI-90	A patient was a responser if a minimum 90% PASI improvement from Baseline was achieved including measure of the average redness (erythema), thickness (induration), and scaliness (scaling); In calculating the PASI, severity is determined by dividing the body into four regions: head (h), upper extremities (u), trunk (t), and lower extremities (l).Each of these areas is assessed separately for erythema, induration, and scaling, which are rated on a scale of 0 (none) to 4 (very severe). Extent of psoriatic involvement is graded as follows: 0 = no involvement; = 1% to 9%; = 10% to 29%; = 30% to 49%; = 50% to 69%; = 70% to 89%; = 90% to 100%. PASI = 0.1 (Eh + lh + Sh) Ah + 0.2 (Eu + lu + Su) Au + 0.3 (Et +lt + St) At + 0.4 (El +ll +Sl) Al	From week 4 to Weeks 12