Study of Efficacy and Safety of Secukinumab in Participants With Moderate-severe Rotator Cuff Tendinopathy : A Randomized, Parallel-group, 24 Week, Double-blind, Placebo-controlled, Multicenter Phase 3 Study to Assess the Efficacy and Safety of Secukinumab Compared to Placebo in Adult Patients With Active Rotator Cuff Tendinopathy

The trial is designed as a randomized, double-blind, placebo-controlled Phase III study over 24 weeks in approximately 234 participants with moderate to severe rotator cuff tendinopathy (RCT), refractory to Standard of Care (Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) course as per local standard practice, if not intolerant or contraindicated, and a course of physiotherapy over a period of 8 weeks).The trial comprises the following periods:- Screening / run-in periodA screening period of up to maximum of 56 days will be used to assess participant eligibility. During this time, the participant can demonstrate that they are refractory to Standard of Care. During the 2-week run-in period prior to the Baseline visit, the participant will need to have 2 weeks of stable NSAID intake and standardized physiotherapy. This is important in order to ensure the participants are refractory to SoC and to establish compliancy with the stabilized dosing of NSAID treatment and physiotherapy regimen to be maintained throughout the study.MRI will be performed during Screening period to exclude other shoulder pathologies and tears (if present) >50%. Evidence of tendinopathy should be established by a centrally read Magnetic Resonance Imaging (MRI). MRI performed within 3 months from baseline may be accepted if deemed suitable by the central reader.Shoulder x-rays will also be performed in order to rule out other shoulder pathologies. Historic x-rays will be accepted if performed ≤ 3 months prior to Baseline.- Study period 1 (Baseline to Week 16)During Study period 1, double-blinded treatment is administered over 12 weeks, reflecting 16 weeks of total drug exposure. Approximately 234 eligible participants will be randomized at Baseline (BSL) in a 1:1 ratio to one of the following arms:Arm 1 (N=117): secukinumab 300 mg s.c. at Day 1 and Weeks 1, 2, 3, 4, 8, and 12Arm 2 (N=117): placebo at Day 1 and Weeks 1, 2, 3, 4, 8, and 12 The last dose of study treatment will be administered at Week 12; the primary outcome assessments will be performed at Week 16.Randomization will be stratified by tear status (no tear/partial tear). Participants should continue on stable NSAID pain medication and a standardized physiotherapy regimen. Reduction in NSAID dose is permitted after BSL, but participants must not increase above dose established during run-in. Use of corticosteroid injections is not permitted during this time.- Study period 2 (Follow-up period)A follow-up period of 8 weeks after the end of the treatment period is planned to assess the maintenance of effect and collect follow-up safety data up to Week 24. Investigator, site personnel, persons performing the assessments and participants will remain blinded, but Novartis clinical trial and submission teams will be unblinded after Week 16 readout. Participants should continue on stable NSAID therapy and physiotherapy during this period. Reduction in NSAID dose is permitted after BSL, but participants must not increase above dose established during run-in. Corticosteroid injections are also not permitted after Week 16.- Off-site proceduresAt the Investigator's discretion, participants may avail of home administration of study drug (self-administered or by a care-giver) at Week 1 and Week 3. Participant and/or caregiver would need to be trained and approved by Investigator for these administrations. Site should have confirmed contact with participant for these home administrations. Tele-visits, i.e., secure videoconferencing, between the Participant and Investigator or designated site staff may also be utilized to support administration of study drug at home.Rescue MedicineAny changes to type of NSAID taken by the participant or any increase in NSAID dosages from stable dose established during run-in period are considered prohibited throughout the duration of the study.If pain or discomfort is intolerable, participants may use non-NSAID medication including, for example, acetaminophen/paracetamol, low-dose opioids and tramadol, as needed. If the participant continues to experience intolerable pain or discomfort, then any increase to the dose of NSAID taken should be kept to an absolute minimum in terms of dosage and duration. Any changes to NSAID type and/or increase in dose will be recorded as a deviation to the protocol but would not result in withdrawal of the participant.Rational for placebo armThe placebo effect in interventional trials in the treatment of RCT is considerable; hence, a placebo control is warranted..

Medienart:	Klinische Studie

Erscheinungsjahr:	2024
Erschienen:	2024

Enthalten in:	ClinicalTrials.gov - (2024) vom: 26. März Zur Gesamtaufnahme - year:2024

Sprache:	Englisch

Links:	Volltext [kostenfrei]

Themen:	610 Phase: Phase 3 Recruitment Status: Recruiting Study Type: Interventional Tendinopathy

Anmerkungen:	Source: Link to the current ClinicalTrials.gov record., First posted: March 7, 2023, Last downloaded: ClinicalTrials.gov processed this data on April 03, 2024, Last updated: April 03, 2024

Study ID:	NCT05758415 CAIN457O12302 2022-502080-38-00
Veröffentlichungen zur Studie:

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PPN (Katalog-ID):	CTG000031976