Psoriasis Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Are between the ages of 18 and 75 years, inclusive, at time of informed consent.
Capable of giving informed consent and complying with study procedures.
Willing and able to adhere to study restrictions.
Laboratory and medical history parameters within the protocol defined ranges.
Body mass index (BMI) of 18.0 to 35.0 kg/m2inclusive.
Have had a diagnosis of moderate-to-severe PP for at least 6 months prior to Baseline.

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:

Pregnant or nursing women.
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
Current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, neurologic, or psychiatric disease.
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.
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.
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.
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.
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.
Other types of psoriasis (such as erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, drug-induced psoriasis) ....

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

120

Study ID:

NCT05772520

Recruitment Status:

Recruiting

Sponsor:

Hangzhou Highlightll Pharmaceutical Co., Ltd

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There are 26 Locations for this study

See Locations Near You

Cahaba
Birmingham Alabama, 35244, United States More Info
Jennifer Perry
Contact
205-778-1564
[email protected]
Justin Perry
Contact
205-778-1564
[email protected]
Vlada Groysman
Principal Investigator
Moy, Fincher, Chipps
Beverly Hills California, 90210, United States More Info
Ron Moy
Principal Investigator
Metropolis Derm
Los Angeles California, 90017, United States More Info
Felicia Moten
Contact
213-319-3339
[email protected]
James Wang
Principal Investigator
Integrative Skin
Sacramento California, 95815, United States More Info
Elaine Ladmirault
Contact
916-524-1216
[email protected]
Yvonne Nong
Contact
916-524-1216
Raja Sivamani
Principal Investigator
Skin Surgical
San Diego California, 92117, United States More Info
Sarah Mohsen
Contact
858-292-5101
[email protected]
Anne Truitt
Principal Investigator
Life Clinical Trials
Coral Springs Florida, 33071, United States More Info
Alondra Escoto
Contact
754-777-2714
[email protected]
Ruth Tecier:
Contact
754-777-2714
Eli Saleeby
Principal Investigator
Leeor Porges, DO
Sub-Investigator
Palm Beach
DeLand Florida, 33484, United States More Info
Sammy Ayoub
Contact
561-559-1516
[email protected]
Myesha Ponder
Contact
561-559-1516
Adam Plotkin
Principal Investigator
D&H Doral Research Center LLC
Doral Florida, 33122, United States More Info
Marlon Hernandez
Contact
786-698-8508
[email protected]
Carlos Martinez
Contact
786-698-8508
[email protected]
Anneyd M. Avalos
Principal Investigator
Anna Cury, MD
Sub-Investigator
Brent M. Schillinger
Sub-Investigator
CNS - Jacksonville
Jacksonville Florida, 32256, United States More Info
Ivy Gabon
Contact
904-281-5757
[email protected]
Brooke McFall, RN
Contact
904-281-5757
[email protected]
Fadi Raji Chalhoub
Principal Investigator
Susan Angel, APRN
Sub-Investigator
Altus Research
Lake Worth Florida, 33461, United States More Info
Florinda Francisco
Contact
561-641-0404
[email protected]
Jim Goldberg
Contact
561-641-0404
Thomas Ross
Principal Investigator
Samuel Lederman, MD
Sub-Investigator
AQUA - Riverchase
Pembroke Pines Florida, 33028, United States
Integrated Clinical Trial Services, Inc
Des Moines Iowa, 50265, United States More Info
Shelby Simpson
Contact
515-229-1413
[email protected]
Rachel Thomas
Contact
515-229-1413
[email protected]
James Coggi
Principal Investigator
Todd Treimer, DO
Sub-Investigator
Mary Barkley, ARNP
Sub-Investigator
Lawrence Green
Rockville Maryland, 20850, United States More Info
Jessica Baccouche
Contact
301-610-0663
[email protected]
Clarissa Ng
Contact
301-610-0663
[email protected]
Lawrence Green
Principal Investigator
Metro Boston
Brighton Massachusetts, 02135, United States More Info
Stella Schandorf
Contact
781-444-0900
[email protected]
Brendan Ng
Contact
781-444-0900
[email protected]
Mark Amster
Principal Investigator
Grekin Skin
Warren Michigan, 48088, United States More Info
Claudia Attala
Contact
586-759-5525
[email protected]
Nick Sharbo
Contact
586-759-5525
[email protected]
Steven Grekin
Principal Investigator
Revival Research Institute
Troy Missouri, 48084, United States More Info
Yamini Donekal
Contact
248-590-0298
[email protected]
Manali Ambegaonkar
Contact
248-590-0298
[email protected]
Ali Moiin
Principal Investigator
Mohammad Zarka, DO
Sub-Investigator
Mount Sinai
New York New York, 10003, United States More Info
Grace Ulerio
Contact
212-844-8811
[email protected]
Vaishnavi Shreedhar
Contact
[email protected]
Alice Gottlieb
Principal Investigator
Remington-Davis, Inc.
Columbus Ohio, 43215, United States More Info
Heather Lee, NP
Contact
614-487-2560
[email protected]
Michelle Chambers
Principal Investigator
Edward Cordasco, DO
Sub-Investigator
DermDox
Sugarloaf Pennsylvania, 18249, United States More Info
Suzy Keagy
Contact
717-439-6900
[email protected]
Angela Lucero
Contact
717-439-6900
[email protected]
Stephen Schleicher
Principal Investigator
Zach Sabaday, PA
Sub-Investigator
CRCC
Charleston South Carolina, 29407, United States More Info
Gina Gregory
Contact
854-333-5455
[email protected]
Christina Dickinson
Contact
854-333-5455
[email protected]
Todd Schlesinger
Principal Investigator
Derm Research
Austin Texas, 78759, United States More Info
Jeremiah Foretenberry
Contact
512-349-9889
[email protected]
David Bushore
Principal Investigator
Studies in Dermatology, LLC
Cypress Texas, 77433, United States More Info
Lilia Garcia
Contact
281-377-6665
[email protected]
Lauren Campbell
Principal Investigator
Sharon R. Kim, MD
Sub-Investigator
Austin Institute for Clinical Research
Pflugerville Texas, 78660, United States More Info
Alivia Hernandez
Contact
512-279-2545
[email protected]
C Bousquet
Contact
512-279-2545
[email protected]
Edward Lain
Principal Investigator
Madeleine Gantz, MD
Sub-Investigator
Progressive Clinical Research Group, Inc.
San Antonio Texas, 78213, United States More Info
Amber Rogers
Contact
210-614-5557
[email protected]
Ryann Magee
Contact
210-614-5557
[email protected]
Mark Lee
Principal Investigator
Theresia Lee, MD
Sub-Investigator
Acclaim
Sugar Land Texas, 77479, United States More Info
Carina Espinoza
Contact
832-770-6388
[email protected]
Syed Ali
Principal Investigator
Premier Clinical Research
Spokane Washington, 99202, United States More Info
Anna Dominguez
Contact
509-998-0238
[email protected]
Celeste Gray
Contact
509-998-0238
[email protected]
Philip Werschler
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

120

Study ID:

NCT05772520

Recruitment Status:

Recruiting

Sponsor:


Hangzhou Highlightll Pharmaceutical Co., Ltd

How clear is this clinincal trial information?

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