Safety and Tolerability of NNC0141-0000-0100 in Subjects With Rheumatoid Arthritis

NCT01370902 | Completed Phase 1

• 3 other identifiers: NN8765-36582010-019234-28U1111-1120-2542
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is conducted in Europe. The aim of this dose-escalating trial is to assess the safety, tolerability, pharmacokinetics (the rate at which the body eliminates the trial drug) and pharmacodynamics (the effect of the investigated drug on the body) of single and repeated doses of NNC141-0100 in subjects with Rheumatoid Arthritis.

Conditions

Inflammation; Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  from trial product administration to week 12

Secondary Outcomes (4)

• Antibodies against NNC141-0100

  from trial product administration until final visit (week 12 or longer if applicable)

• Area under the serum concentration-time curve - SD trial part

  from trial product administration until final visit (week 12 or longer if applicable)

• Terminal half-life (t½) - SD trial part

  from trial product administration until final visit (week 12 or longer if applicable)

• Terminal half-life (t½) - MD trial part

  from trial product administration until final visit (week 12 or longer if applicable)

Study Arms (3)

Single-dose (SD) trial part (i.v.)

EXPERIMENTAL

Drug: NNC 0141-0000-0100; Drug: placebo

Single-dose (SD) trial part (s.c.)

EXPERIMENTAL

Drug: NNC 0141-0000-0100; Drug: placebo

Multiple-dose (MD) trial part (s.c.)

EXPERIMENTAL

Drug: NNC 0141-0000-0100; Drug: placebo

Interventions

NNC 0141-0000-0100 DRUG

Single dose administered subcutaneously (under the skin), up to six dose levels. Progression to next dose will be based on safety evaluation. Initiation of the MD s.c. phase will depend on the results from the SD i.v. cohorts as well as the first two dose cohorts of the SD s.c. part

Single-dose (SD) trial part (s.c.)

placebo DRUG

Single dose administered subcutaneously (under the skin) as a comparator at all dose levels

Single-dose (SD) trial part (s.c.)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of rheumatoid arthritis (RA) according to the American College of Rheumatology (ACR1987 classification) of at least 3 months duration prior to randomisation
• Active Rheumatoid Arthritis (RA) characterised by a DAS28-CRP (Disease Activity Score of 28 joints, calculated with CRP (C-reactive protein) value) greater than or equal to 3.2
• Females must be post-menopausal or surgically sterile (post-menopausal for at least 1 year) or be willing to use highly effective method of birth control
• Males must be willing to use highly effective contraception
• Subjects on stable doses of methotrexate (7.5 to 25 mg/week, both inclusive) for at least 4 weeks prior to randomisation

Sponsors & Collaborators

• Innate Pharma: lead

Study Sites (1)

Unknown Facility

Berlin, 13353, Germany

Location

MeSH Terms

Conditions

Inflammation; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Renaud Buffet

  Innate Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2011
• First Posted: June 10, 2011
• Study Start: May 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: December 23, 2014

Record last verified: 2014-12

Locations

DE (1)