--- title: "A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy and Safety of NNC0114-0006 in Subjects With Active Crohn's Disease" nct_id: NCT01751152 overall_status: COMPLETED phase: PHASE2 sponsor: Novo Nordisk A/S study_type: INTERVENTIONAL primary_condition: Inflammation countries: United States, Bulgaria, Czechia, Poland, Slovakia, Spain canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01751152.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01751152" ct_last_update_post_date: 2017-03-31 last_seen_at: "2026-05-12T06:42:48.713Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy and Safety of NNC0114-0006 in Subjects With Active Crohn's Disease **NCT ID:** [NCT01751152](https://clinicaltrials.gov/study/NCT01751152) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE2 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 53 - **Lead Sponsor:** Novo Nordisk A/S - **Conditions:** Inflammation, Crohn's Disease - **Start Date:** 2013-02 - **Completion Date:** 2014-12 - **CT.gov Last Update:** 2017-03-31 ## Brief Summary This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn's disease. ## Eligibility - **Minimum age:** 18 Years - **Maximum age:** 75 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: * Moderately to severely active Crohn's disease, defined as a Crohn's disease activity index (CDAI) of 220-450 (both inclusive) at Visit 2 (Day 0, Dosing), with evidence of inflammation confirmed by a C-reactive protein (CRP) above or equal to 10 mg/L or endoscopic verification (according to endoscopy imaging manual) performed at Visit 1 (Day -28 to -7, Screening) * Biologic-naïve subjects or biologic-experienced for the treatment of Crohn's disease. Biologic-experienced subjects are eligible if they have not failed more than one marketed biologic therapy for the treatment of Crohn's disease due to lack of efficacy (primary or secondary efficacy failures) Exclusion Criteria: * Body mass index (BMI) equal to or above 38.0 kg/m\^2 * Any of the following: symptomatic bowel obstruction, short bowel syndrome, ileostomy or colostomy, surgical bowel resection within 6 months prior to randomisation, total colectomy or subtotal colectomy with less than 20 cm colon remaining, any abscesses not adequately treated * History of dysplasia in the colon * Any active or ongoing bacterial infections within 4 weeks prior to randomisation, unless treated and resolved with appropriate therapy * Any history of serious recurrent infections requiring hospitalisation ``` ## Arms - **NNC0114-0006** (EXPERIMENTAL) - **Placebo** (PLACEBO_COMPARATOR) ## Interventions - **NNC0114-0006** (DRUG) — A single i.v. (intravenous, into the vein) dose. At week 12 the possibility to administer an additional open-label dose of NNC0114-0006 will be provided to all subjects irrespective of initial treatment allocation as long as they are not in need of rescue medication, as judged by the clinical investigator. - **placebo** (DRUG) — A single i.v. (intravenous, into the vein) dose. At week 12 the possibility to administer an additional open-label dose of NNC0114-0006 will be provided to all subjects irrespective of initial treatment allocation as long as they are not in need of rescue medication, as judged by the clinical investigator. ## Primary Outcomes - **Change in Crohn's disease activity index (CDAI)** _(time frame: Week 0, week 4)_ ## Secondary Outcomes - **Change in CDAI** _(time frame: Week 0, week 12)_ - **Clinical remission, defined as CDAI of less than 150** _(time frame: At week 8)_ - **Change in the inflammatory bowel disease questionnaire (IBDQ) score** _(time frame: Week 0, week 4)_ - **Changes in the Short Form Health Survey (SF-36v2) physical and mental component scores** _(time frame: Week 0, week 4)_ - **Incidence of adverse events (AEs)** _(time frame: Up to weeks 24 or 36)_ - **Incidence of anti-NNC0114-0006 antibodies** _(time frame: Up to weeks 24 or 36)_ ## Locations (28) - Novo Nordisk Investigational Site, Tucson, Arizona, United States - Novo Nordisk Investigational Site, Little Rock, Arkansas, United States - Novo Nordisk Investigational Site, Little Rock, Arkansas, United States - Novo Nordisk Investigational Site, Laguna Hills, California, United States - Novo Nordisk Investigational Site, Clearwater, Florida, United States - Novo Nordisk Investigational Site, Miami, Florida, United States - Novo Nordisk Investigational Site, Jefferson City, Missouri, United States - Novo Nordisk Investigational Site, Jackson, Tennessee, United States - Novo Nordisk Investigational Site, Houston, Texas, United States - Novo Nordisk Investigational Site, Sofia, Bulgaria - Novo Nordisk Investigational Site, Sofia, Bulgaria - Novo Nordisk Investigational Site, Varna, Bulgaria - Novo Nordisk Investigational Site, Hradec Králové, Czechia - Novo Nordisk Investigational Site, Olomouc, Czechia - Novo Nordisk Investigational Site, Olomouc, Czechia - Novo Nordisk Investigational Site, Prague, Czechia - Novo Nordisk Investigational Site, Częstochowa, Poland - Novo Nordisk Investigational Site, Szczecin, Poland - Novo Nordisk Investigational Site, Banská Bystrica, Slovakia - Novo Nordisk Investigational Site, Bratislava, Slovakia - Novo Nordisk Investigational Site, Ružomberok, Slovakia - Novo Nordisk Investigational Site, Barcelona, Spain - Novo Nordisk Investigational Site, Barcelona, Spain - Novo Nordisk Investigational Site, Madrid, Spain - Novo Nordisk Investigational Site, Santander, Spain - Novo Nordisk Investigational Site, Seville, Spain - Novo Nordisk Investigational Site, Seville, Spain - Novo Nordisk Investigational Site, Valencia, Spain ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|tucson|arizona|united states` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|little rock|arkansas|united states` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|laguna hills|california|united states` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|clearwater|florida|united states` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|miami|florida|united states` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|jefferson city|missouri|united states` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|jackson|tennessee|united states` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|houston|texas|united states` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|sofia||bulgaria` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|varna||bulgaria` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|hradec králové||czechia` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|olomouc||czechia` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|prague||czechia` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|częstochowa||poland` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|szczecin||poland` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|banská bystrica||slovakia` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|bratislava||slovakia` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|ružomberok||slovakia` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|barcelona||spain` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|madrid||spain` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|santander||spain` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|seville||spain` — added _(2026-05-12)_ - `locations.novo nordisk investigational site|valencia||spain` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT01751152.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT01751152* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*