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Long-Term Extension Trial of Tildrakizumab to Prove Its Safety in Subjects With Psoriatic Arthritis Who Have Previously Completed Study With Tildrakizumab.
Phase 2, PHASE3 trial testing SUNPG18_07 I (Tildrakizumab 200 mg) in Psoriatic Arthritis in 281 participants. Completed in 18 September 2023.
| Lead sponsor | Sun Pharmaceutical Industries Limited |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 281 |
| Start date | 11 July 2018 |
| Primary completion | 18 September 2023 |
| Estimated completion | 18 September 2023 |
| Sites | 66 locations across Russia, Ukraine, Poland, Hungary, Mexico, Argentina, United States, Spain |
Sun Pharmaceutical Industries Limited — full company profile →
18 and older, any sex, with Psoriatic Arthritis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Please refer to Adverse event section for more information
| Group | Value | 95% CI |
|---|---|---|
| Tildrakizumab 200 mg q4 Weeks | 5 | |
| Tildrakizumab 200 mg q12 Weeks | 14 | |
| Tildrakizumab 100 mg q12 Weeks | 36 | |
| Tildrakizumab 200 mg q4 Weeks Switched to Tildrakizumab 100 mg q12 Weeks | 44 | |
| Tildrakizumab 200 mg q12 Weeks Switched to Tildrakizumab 100 mg q12 Weeks | 125 |
Time frame: Week 208. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Tildrakizumab 200 mg, q4 W… | Tildrakizumab 200 mg, q12 … | Tildrakizumab 100 mg q12 W… | Tildrakizumab 200 mg q4 We… | Tildrakizumab 200 mg q12 W… |
|---|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | — | — | — | — | — |
| COVID-19 pneumonia | Infections and infestations | — | — | — | — | — |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | — | — | — | — | — |
| Deep vein thrombosis | Vascular disorders | — | — | — | — | — |
| Hypertension | Vascular disorders | — | — | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — | — | — |
| Cardiac failure | Cardiac disorders | — | — | — | — | — |
| Coronary artery stenosis | Cardiac disorders | — | — | — | — | — |
| Tachycardia | Cardiac disorders | — | — | — | — | — |
| Abdominal hernia | Gastrointestinal disorders | — | — | — | — | — |
| Haemorrhagic erosive gastritis | Gastrointestinal disorders | — | — | — | — | — |
| Intestinal obstruction | Gastrointestinal disorders | — | — | — | — | — |
| Generalised oedema | General disorders | — | — | — | — | — |
| Cholelithiasis | Hepatobiliary disorders | — | — | — | — | — |
| Abdominal abscess | Infections and infestations | — | — | — | — | — |
| Gallbladder empyema | Infections and infestations | — | — | — | — | — |
| Intestinal sepsis | Infections and infestations | — | — | — | — | — |
| Septic shock | Infections and infestations | — | — | — | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — | — | — | — |
| Craniocerebral injury | Injury, poisoning and procedural complications | — | — | — | — | — |
| Hip fracture | Injury, poisoning and procedural complications | — | — | — | — | — |
| Humerus fracture | Injury, poisoning and procedural complications | — | — | — | — | — |
| Ligament rupture | Injury, poisoning and procedural complications | — | — | — | — | — |
| Subdural haematoma | Injury, poisoning and procedural complications | — | — | — | — | — |
| Tibia fracture | Injury, poisoning and procedural complications | — | — | — | — | — |
| Reaction | System | Tildrakizumab 200 mg, q4 W… | Tildrakizumab 200 mg, q12 … | Tildrakizumab 100 mg q12 W… | Tildrakizumab 200 mg q4 We… | Tildrakizumab 200 mg q12 W… |
|---|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | — | — | — | — | — |
| Nasopharyngitis | Infections and infestations | — | — | — | — | — |
| Urinary tract infection | Infections and infestations | — | — | — | — | — |
| Rhinitis | Infections and infestations | — | — | — | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — | — |
| Hypertension | Vascular disorders | — | — | — | — | — |
| Pharyngitis | Infections and infestations | — | — | — | — | — |
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | — | — | — | — | — |
| Weight increased | Investigations | — | — | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — | — |
| Hypercholesterolaemia | Metabolism and nutrition disorders | — | — | — | — | — |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | — | — | — | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — | — | — |
| Gamma-glutamyltransferase increased | Investigations | — | — | — | — | — |
| Psoriasis | Skin and subcutaneous tissue disorders | — | — | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — | — | — |
| Fatigue | General disorders | — | — | — | — | — |
| Pyrexia | General disorders | — | — | — | — | — |
| Influenza | Infections and infestations | — | — | — | — | — |
| Pneumonia | Infections and infestations | — | — | — | — | — |
| Sinusitis | Infections and infestations | — | — | — | — | — |
| Ligament sprain | Injury, poisoning and procedural complications | — | — | — | — | — |
| Dyslipidaemia | Metabolism and nutrition disorders | — | — | — | — | — |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | — | — | — | — | — |
| Sciatica | Nervous system disorders | — | — | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — | — | — |
| Dental caries | Gastrointestinal disorders | — | — | — | — | — |
| Toothache | Gastrointestinal disorders | — | — | — | — | — |
| Hepatic steatosis | Hepatobiliary disorders | — | — | — | — | — |
| Allergy to arthropod bite | Immune system disorders | — | — | — | — | — |
| COVID-19 pneumonia | Infections and infestations | — | — | — | — | — |
| Cystitis | Infections and infestations | — | — | — | — | — |
| Gastroenteritis | Infections and infestations | — | — | — | — | — |
| Respiratory tract infection viral | Infections and infestations | — | — | — | — | — |
| Contusion | Injury, poisoning and procedural complications | — | — | — | — | — |
| Foot fracture | Injury, poisoning and procedural complications | — | — | — | — | — |
| Muscle strain | Injury, poisoning and procedural complications | — | — | — | — | — |
Most-reported serious reactions: Acute myocardial infarction, COVID-19 pneumonia, Osteoarthritis, Deep vein thrombosis, Hypertension, Anaemia, Cardiac failure, Coronary artery stenosis.
Data from ClinicalTrials.gov NCT03552276 adverse events section.
A long term study to demonstrate the safety of Tildrakizumab in Subjects with Psoriatic Arthritis who Have Previously Completed Study with Tildrakizumab
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Currently open trials in the same condition.
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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/NCT03552276.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing