NCT02202395 (T8) is a Phase 1/Phase 2 clinical trial of LTS 0.25mg in Rheumatoid Arthritis, sponsored by Shanghai Pharmaceuticals Holding Co., Ltd.

Who is sponsoring NCT02202395?

NCT02202395 is sponsored by Shanghai Pharmaceuticals Holding Co., Ltd.

What drugs are being tested in NCT02202395?

Interventions in NCT02202395: LTS 0.25mg, LTS 0.5mg, LTS 1.0mg, Placebo.

What condition does NCT02202395 study?

NCT02202395 studies Rheumatoid Arthritis.

Is NCT02202395 still recruiting?

NCT02202395 is currently completed. Last updated 2 June 2017.

Last reviewed 2017-06-02 · How we verify

NCT02202395: T8

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Radomized, Double-blind, and Placebo-controlled Multicenter Clinical Trial of Hydroxytriptolide, in Active Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate

Completed Phase 1/Phase 2 Last updated 2 June 2017

What this trial tests

Phase 1/Phase 2 trial testing LTS 0.25mg in Rheumatoid Arthritis in 120 participants. Completed in 28 December 2016.

Timeline

1 June 2014

Primary endpoint
30 April 2015

28 December 2016

Quick facts

Lead sponsor	Shanghai Pharmaceuticals Holding Co., Ltd
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	120
Start date	1 June 2014
Primary completion	30 April 2015
Estimated completion	28 December 2016
Sites	5 locations across China

Drugs / interventions tested

LTS 0.25mg — full drug profile →
LTS 0.5mg — full drug profile →
LTS 1.0mg — full drug profile →
Placebo

Conditions studied

Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →

Sponsor

Shanghai Pharmaceuticals Holding Co., Ltd — full company profile →

Who can join

Adults 35 to 65, female only, with Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Change from baseline in ACR 20 at 12 weeks and at 24 weeks
Time frame: 12weeks, 24weeks

Sponsor's own description

The purpose of this study is to investigate the efficacy and safety of Hydroxytriptolide(LTS) in active rheumatoid arthritis patients with an inadequate response to methotrexate.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Mechanisms of cancer cell death induction by triptolide: A comprehensive overview.
Feng K, Li X, Bai Y, Zhang D, et al · · 2024 · cited 14× · PMID 38293343 · DOI 10.1016/j.heliyon.2024.e24335
Triptolide-mediated immunomodulation of macrophages: from pathophysiology to therapy.
Chen Y, Zhu Q, Yin A, Wang W, et al · · 2025 · cited 2× · PMID 41144250 · DOI 10.1080/07853890.2025.2575302

Verify or expand the search:

Other recruiting trials for Rheumatoid Arthritis

Currently open trials in the same condition.

NCT07433335 — A Study to Assess the Safety and Tolerability of SR-878 in Patients With Rheumatoid Arthritis · Phase 1 · recruiting
NCT07491016 — Efficacy and Safety of Telitacicept Combined With Baricitinib for Refractory Rheumatoid Arthritis · recruiting
NCT07171983 — A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986454 in Participants With Rheumatoid Arthritis · Phase 1 · recruiting
NCT07246096 — Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Rel · EARLY_PHASE1 · recruiting
NCT07363590 — A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004) · Phase 1 · recruiting

Other Shanghai Pharmaceuticals Holding Co., Ltd trials

Trials by the same sponsor.

NCT06839131 — A Clinical Study of SPH9788 Tablets in Healthy Chinese Subjects. · Phase 1 · recruiting
NCT06487455 — A Clinical Study of SPH7485 Tablets in the Treatment of Advanced Solid Tumors. · Phase 1 · recruiting
NCT06434597 — A Clinical Study of SPH5030 Tablets in the Treatment of Her2-positive/Mutated Biliary Tract OR Colorectal Cancer Patient · Phase 2 · recruiting
NCT06483373 — A Clinical Study of SPH7854 Granules in Healthy Subjects. · EARLY_PHASE1 · recruiting
NCT05046314 — A Clinical Study of TK216 in Patients With Relapsed or Refractory Ewing's Sarcoma · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02202395 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Shanghai Pharmaceuticals Holding Co., Ltd
Last refreshed: 2 June 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02202395.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing