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NCT00770965
Phase II Efficacy Study Looking at a Single-dose of One of Three Dose Levels of AIN457 in Patients With Chronic Plaque-type Psoriasis
Phase 2 trial testing AIN457 in Chronic Plaque Psoriasis in 80 participants. Completed in 17 September 2009.
17 September 2009
Quick facts
| Lead sponsor | Novartis Pharmaceuticals |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 10 September 2008 |
| Primary completion | 17 September 2009 |
| Estimated completion | 17 September 2009 |
| Sites | 5 locations across United States |
Drugs / interventions tested
- AIN457 — full drug profile →
- Placebo
Conditions studied
- Chronic Plaque Psoriasis — all drugs for Chronic Plaque Psoriasis →
Sponsor
Novartis Pharmaceuticals — full company profile →
Who can join
Adults 18 to 65, any sex, with Chronic Plaque Psoriasis. Patients with the condition only — healthy volunteers not accepted.
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Serious adverse events (2 terms)
| Reaction | System | AIN457 0.3 mg/kg | AIN457 1 mg/kg | AIN457 3 mg/kg | Placebo |
|---|---|---|---|---|---|
| FEMORAL HERNIA, OBSTRUCTIVE | Gastrointestinal disorders | — | — | — | — |
| HIP FRACTURE | Injury, poisoning and procedural complications | — | — | — | — |
Other adverse events (31 terms — click to expand)
| Reaction | System | AIN457 0.3 mg/kg | AIN457 1 mg/kg | AIN457 3 mg/kg | Placebo |
|---|---|---|---|---|---|
| NASOPHARYNGITIS | Infections and infestations | — | — | — | — |
| SINUS CONGESTION | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| HYPERTENSION | Vascular disorders | — | — | — | — |
| ABDOMINAL PAIN | Gastrointestinal disorders | — | — | — | — |
| NAUSEA | Gastrointestinal disorders | — | — | — | — |
| NECROTISING COLITIS | Gastrointestinal disorders | — | — | — | — |
| VOMITING | Gastrointestinal disorders | — | — | — | — |
| CYST | General disorders | — | — | — | — |
| INFLUENZA LIKE ILLNESS | General disorders | — | — | — | — |
| OEDEMA PERIPHERAL | General disorders | — | — | — | — |
| GENITAL HERPES | Infections and infestations | — | — | — | — |
| HERPES ZOSTER | Infections and infestations | — | — | — | — |
| SINUSITIS | Infections and infestations | — | — | — | — |
| TOOTH INFECTION | Infections and infestations | — | — | — | — |
| BACK INJURY | Injury, poisoning and procedural complications | — | — | — | — |
| HYPERTRIGLYCERIDAEMIA | Metabolism and nutrition disorders | — | — | — | — |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | — | — | — | — |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | — | — | — | — |
| MELANOCYTIC NAEVUS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — |
| DIZZINESS | Nervous system disorders | — | — | — | — |
| HEADACHE | Nervous system disorders | — | — | — | — |
| MIGRAINE | Nervous system disorders | — | — | — | — |
| DEPRESSION | Psychiatric disorders | — | — | — | — |
| PHARYNGOLARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| PSORIASIS | Skin and subcutaneous tissue disorders | — | — | — | — |
| RASH | Skin and subcutaneous tissue disorders | — | — | — | — |
| APHTHOUS STOMATITIS | Gastrointestinal disorders | — | — | — | — |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | — | — | — | — |
| PERIRECTAL ABSCESS | Infections and infestations | — | — | — | — |
| PNEUMONIA | Infections and infestations | — | — | — | — |
| INSOMNIA | Psychiatric disorders | — | — | — | — |
Most-reported serious reactions: FEMORAL HERNIA, OBSTRUCTIVE, HIP FRACTURE.
Data from ClinicalTrials.gov NCT00770965 adverse events section.
Sponsor's own description
This is an exploratory, 4 arm, parallel group, placebo-controlled study comparing three doses of AIN457 to placebo. Subjects with a diagnosis of moderate to severe chronic plaque psoriasis will be randomized to receive either AIN457 at one of the three doses studied or placebo.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00770965
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of AIN457
Trials testing the same drug.
- NCT04711902 — Study of Efficacy and Safety of Secukinumab in Chinese Subjects With Active PsA Compared to Placebo. · Phase 3 · completed
- NCT03136861 — SKIPPAIN - Speed of Onset of SecuKinumab-Induced Relief From Pain in Patients With AxIal SpoNdyloarthritis · Phase 3 · completed
- NCT02607774 — Investigate Effect of Secukinumab on the PK of Midazolam in Patients With Mod to Sev Plaque Psoriasis · Phase 1 · completed
- NCT01364389 — A 3-arm Proof of Concept Study of AIN457, ACZ885 or Corticosteroids in Patients With Polymyalgia Rheumatica · Phase 2 · terminated
- NCT01132612 — AIN457 Regimen Finding Extension Study in Participants With Moderate to Severe Psoriasis · Phase 2 · completed
Other recruiting trials for Chronic Plaque Psoriasis
Currently open trials in the same condition.
- NCT07337434 — To Check Comparison of Apremilast and Methotrexate Efficacy in Patients With Moderate to Severe Plaque Psoriasis Present · EARLY_PHASE1 · recruiting
Other Novartis Pharmaceuticals trials
Trials by the same sponsor.
- NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
- NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
- NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
- NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
- NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00770965 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
- Last refreshed: 12 March 2018
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/NCT00770965.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing