A Dose-Range Finding Study for ALX-0061 Combination Therapy in Subjects With Rheumatoid Arthritis

August 6, 2019 updated by: Ablynx

A Phase IIb Multicenter, Randomized, Double-blind, Placebo-Controlled Dose-Range Finding Study of ALX-0061 Administered Subcutaneously in Combination With Methotrexate, in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy

The purpose of this study is to assess the efficacy and safety of dose regimens of ALX-0061 administered subcutaneously (s.c.) in combination with methotrexate (MTX) to subjects with active rheumatoid arthritis (RA) despite MTX therapy, compared with placebo.

To assess the effects of ALX-0061 on quality of life, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of ALX-0061, and to define the optimal dose regimen for ALX-0061, based on safety and efficacy, for further clinical development.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Subjects who completed the 24-week assessment period and achieved at least 20% improvement in swollen joint count (SJC) and/or tender joint count (TJC) at Week 24 of study ALX0061-C201 were invited to participate in an open-label extension (OLE) study ALX0061-C203 (NCT02518620), if the study was approved in their country and selection criteria were met.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
345

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Investigator Site
      • Brussels, Belgium, 1070
        • Investigator Site
      • Ghent, Belgium, 9000
        • Investigator Site
      • Liège, Belgium, 4000
        • Investigator Site
  • Bulgaria
      • Pleven, Bulgaria, 5800
        • Investigator Site
      • Plovdiv, Bulgaria, 4001
        • Investigator Site
      • Ruse, Bulgaria, 7000
        • Investigator Site 1
      • Ruse, Bulgaria, 7000
        • Investigator Site 2
      • Sofia, Bulgaria, 1612
        • Investigator Site
      • Sofia, Bulgaria, 1233
        • Investigator Site
      • Varna, Bulgaria, 9000
        • Investigator Site
  • Czechia
      • Brno, Czechia, 60200
        • Investigator Site
      • Olomouc, Czechia, 77900
        • Investigator Site
      • Prague, Czechia
        • Investigator Site
      • Prague, Czechia, 12850
        • Investigator Site
      • Zlin, Czechia, 76001
        • Investigator Site
  • Georgia
      • Tbilisi, Georgia, 0102
        • Investigator Site
      • Tbilisi, Georgia, 0159
        • Investigator Site 1
      • Tbilisi, Georgia, 0159
        • Investigator Site 2
      • Tbilisi, Georgia, 0160
        • Investigator Site
      • Tbilisi, Georgia, 0179
        • Investigator Site
  • Germany
      • Bad Nauheim, Germany, 61231
        • Investigator Site
      • Berlin, Germany, 10117
        • Investigator Site
      • Berlin, Germany
        • Investigator Site
      • Cologne, Germany, 50973
        • Investigator Site
      • Frankfurt, Germany
        • Investigator Site
      • Hamburg, Germany, 22081
        • Investigator Site
  • Hungary
      • Baja, Hungary, 6500
        • Investigator Site
      • Balatonfüred, Hungary, 8230
        • Investigator Site
      • Budapest, Hungary, 1038
        • Investigator Site
      • Békéscsaba, Hungary, 5600
        • Investigator Site
      • Gyula, Hungary, 5700
        • Investigator Site
      • Szikszó, Hungary, 3800
        • Investigator Site
      • Székesfehérvar, Hungary, 8000
        • Investigator Site
      • Veszprém, Hungary, 8200
        • Investigator Site
  • Mexico
      • Culiacan, Mexico, 80000
        • Investigator Site
      • Leon, Mexico, 37000
        • Investigator Site
      • Merida, Mexico, 97070
        • Investigator Site
      • Mexico City, Mexico, 03100
        • Investigator Site 1
      • Mexico City, Mexico, 06700
        • Investigator Site 2
      • Monclova, Mexico, 25714
        • Investigator Site
      • Monterey, Mexico, 64000
        • Investigator Site
      • Monterey, Mexico, 64460
        • Investigator Site
  • Moldova, Republic of
      • Chisinau, Moldova, Republic of, 2025
        • Investigator Site
  • North Macedonia
      • Skopje, North Macedonia, 1000
        • Investigator Site 1
      • Skopje, North Macedonia, 1000
        • Investigator Site 2
  • Poland
      • Bydgoszcz, Poland, 85168
        • Investigator Site
      • Elblag, Poland
        • Investigator Site
      • Elblag, Poland, 82300
        • Investigator Site
      • Gdynia, Poland, 81338
        • Investigator Site
      • Grodzisk Mazowiecki, Poland, 05825
        • Investigator Site
      • Katowice, Poland, 40954
        • Investigator Site
      • Lublin, Poland, 20582
        • Investigator Site
      • Poznan, Poland, 60773
        • Investigator Site
      • Sochaczew, Poland, 96500
        • Investigator Site
      • Torun, Poland, 87100
        • Investigator Site
      • Warszawa, Poland, 02653
        • Investigator Site
  • Romania
      • Braila, Romania, 800578
        • Investigator Site
      • Bucharest, Romania, 010976
        • Investigator Site
      • Bucharest, Romania, 020475
        • Investigator Site
      • Oradea, Romania, 410028
        • Investigator Site
      • Targu Mures, Romania, 540142
        • Investigator Site
      • Timisoara, Romania, 300057
        • Investigator Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Investigator Site 1
      • Belgrade, Serbia, 11000
        • Investigator Site 2
      • Belgrade, Serbia, 11000
        • Investigator Site 3
      • Niska Banja, Serbia, 18205
        • Investigator Site
      • Novi Sad, Serbia, 21112
        • Investigator Site
  • Spain
      • Madrid, Spain, 28007
        • Investigator Site
      • Madrid, Spain, 28041
        • Investigator Site
      • Salamanca, Spain, 37007
        • Investigator Site
      • Santiago de Compostela, Spain, 15702
        • Investigator Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35216
        • Investigator Site
    • California
      • Hemet, California, United States, 92543
        • Investigator Site
      • La Palma, California, United States, 90712
        • Investigator Site
      • Los Angeles, California, United States, 90017
        • Investigator Site
      • Los Angeles, California, United States, 90036
        • Investigator Site
      • Ventura, California, United States, 93003
        • Investigator Site
    • Florida
      • Hialeah, Florida, United States, 33016
        • Investigator Sites
      • Homestead, Florida, United States, 33030
        • Investigator Site
      • Miami, Florida, United States, 33135
        • Investigator Site
      • Miami Lakes, Florida, United States, 33016
        • Investigator Site
      • Orlando, Florida, United States, 32804
        • Investigator Site
    • Georgia
      • Stockbridge, Georgia, United States, 30281
        • Investigator Site
    • Kansas
      • Overland Park, Kansas, United States, 66209
        • Investigator Site
    • Louisiana
      • Monroe, Louisiana, United States, 71203
        • Investigator Site
    • Massachusetts
      • Worcester, Massachusetts, United States, 01605
        • Investigator Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Investigator Site
    • New York
      • Brooklyn, New York, United States, 11201
        • Investigator Site
      • New York, New York, United States, 10018
        • Investigator Site
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Investigator Sie
      • Myrtle Beach, South Carolina, United States, 29572
        • Investigator Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Investigator Site
    • Texas
      • Mesquite, Texas, United States, 75150
        • Investigator Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 74 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of RA for at least 6 months prior to screening, and American College of Rheumatology (ACR) functional class I-III
  • Subjects treated with and tolerating MTX
  • Active RA
  • Others as defined in the protocol

Exclusion Criteria:

  • Have been treated with disease-modifying antirheumatic drugs (DMARDs)/systemic immunosuppressives other than MTX.
  • Have received approved or investigational biological or targeted synthetic DMARD therapies for RA less than 6 months prior to screening.
  • Have a history of toxicity, non-tolerance, primary non-response or inadequate response to a biological therapy, or targeted synthetic DMARDs, for RA.
  • Have received prior therapy blocking the interleukin-6 (IL-6) pathway, at any time.
  • Others as defined in the protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PLACEBO_COMPARATOR: Placebo q2w + MTX
Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.
Other: Placebo
Drug: Methotrexate
Stable background dose of commercially available methotrexate (not provided by the Sponsor).
EXPERIMENTAL: ALX-0061 75 mg q4w + MTX
ALX-0061 75 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.
Other: Placebo
Biological: ALX-0061
Drug: Methotrexate
Stable background dose of commercially available methotrexate (not provided by the Sponsor).
EXPERIMENTAL: ALX-0061 150 mg q4w + MTX
ALX-0061 150 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.
Other: Placebo
Biological: ALX-0061
Drug: Methotrexate
Stable background dose of commercially available methotrexate (not provided by the Sponsor).
EXPERIMENTAL: ALX-0061 150 mg q2w + MTX
ALX-0061 150 mg every 2 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.
Other: Placebo
Biological: ALX-0061
Drug: Methotrexate
Stable background dose of commercially available methotrexate (not provided by the Sponsor).
EXPERIMENTAL: ALX-0061 225 mg q2w + MTX

ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24.

The last study drug administration was at the Week 22 visit.
Biological: ALX-0061
Drug: Methotrexate
Stable background dose of commercially available methotrexate (not provided by the Sponsor).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number and Percentage of Subjects Achieving American College of Rheumatology (ACR) 20 Response at Week 12
Time Frame: Week 12

ACR 20 response is defined as:

  • 20% improvement in tender joint count (TJC; 68 joints) relative to Week 0 AND
  • 20% improvement in swollen joint count (SJC; 66 joints) relative to Week 0 AND

  • 20% improvement in 3 of the following 5 areas relative to Week 0:

    • Subject's Assessment of Pain (100 mm - visual analogue scale [VAS])
    • Subject's Global Assessment of Disease Activity (VASPA)
    • Physician's Global Assessment of Disease Activity (VASPHA)
    • Subject's assessment of physical function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI)
    • C-reactive protein (CRP) level

The primary endpoint was analyzed using non-responder imputation (NRI), i.e., subjects with missing ACR20 response at Week 12 were treated as non responders.
Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number and Percentage of Subjects With ACR20 Response at Week 24
Time Frame: 24 weeks

ACR 20 response is defined as:

  • 20% improvement in tender joint count (TJC; 68 joints) relative to Week 0 AND
  • 20% improvement in swollen joint count (SJC; 66 joints) relative to Week 0 AND

  • 20% improvement in 3 of the following 5 areas relative to Week 0:

    • Subject's Assessment of Pain (100 mm - visual analogue scale [VAS])
    • Subject's Global Assessment of Disease Activity (VASPA)
    • Physician's Global Assessment of Disease Activity (VASPHA)
    • Subject's assessment of physical function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI)
    • C-reactive protein (CRP) level

This endpoint was analyzed using NRI, i.e., subjects with missing response at Week 24 were treated as non responders.
24 weeks
Number and Percentage of Subjects With ACR50 Response at Weeks 12 and 24
Time Frame: 24 weeks

ACR50 response is defined as:

  • 50% improvement in TJC (68 joints) relative to Week 0 AND
  • 50% improvement in SJC (66 joints) relative to Week 0 AND

  • 50% improvement in 3 of the following 5 areas relative to Week 0:

    • Subject's Assessment of Pain (100 mm - VAS)
    • Subject's Global Assessment of Disease Activity (VASPA)
    • Physician's Global Assessment of Disease Activity (VASPHA)
    • Subject's assessment of physical function as measured by HAQ-DI
    • CRP level

This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non responders.
24 weeks
Number and Percentage of Subjects With ACR70 Response at Weeks 12 and 24
Time Frame: 24 weeks

ACR70 response is defined as:

  • 70% improvement in TJC (68 joints) relative to Week 0 AND
  • 70% improvement in SJC (66 joints) relative to Week 0 AND

  • 70% improvement in 3 of the following 5 areas relative to Week 0:

    • Subject's Assessment of Pain (100 mm - VAS)
    • Subject's Global Assessment of Disease Activity (VASPA)
    • Physician's Global Assessment of Disease Activity (VASPHA)
    • Subject's assessment of physical function as measured by HAQ-DI
    • CRP level

This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non responders.
24 weeks
Number and Percentage of Subjects With Low Disease Activity (LDA) Using Disease Activity Score 28 (DAS28) Using C-reactive Protein (CRP) at Weeks 12 and 24
Time Frame: 24 weeks

DAS28(CRP) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.36 × ln[CRP+1]) + (0.014 × VASPA) + 0.96

Low disease activity = 2.6 ≤ DAS28 ≤ 3.2

This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non responders.
24 weeks
Number and Percentage of Subjects With LDA Using DAS28 Using Erythrocyte Sedimentation Rate (ESR) at Weeks 12 and 24
Time Frame: 24 weeks

DAS28(ESR) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.70 × ln[ESR]) +(0.014 × VASPA)

Low disease activity = 2.6 ≤ DAS28 ≤ 3.2

Subjects with low disease activity includes subjects who are in remission. This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non responders.
24 weeks
Number and Percentage of Subjects With LDA Using Simplified Disease Activity Index (SDAI) at Weeks 12 and 24
Time Frame: 24 weeks

SDAI = TJC28 + SJC28 + Patient's Global Assessment of Disease Activity (VASPA) + Physician's Global Assessment of Disease Activity (VASPHA) + CRP (mg/dL)

Low disease activity: 3.3 < SDAI ≤ 11.0

Subjects with low disease activity includes subjects who are in remission. This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non responders.
24 weeks
Number and Percentage of Subjects With LDA Using Clinical Disease Activity Index (CDAI) at Weeks 12 and 24
Time Frame: 24 weeks

CDAI = TJC28 + SJC28 + VASPA + VASPHA

Low disease activity: 2.8 < CDAI ≤ 10

Subjects with low disease activity includes subjects who are in remission. This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non responders.
24 weeks
Number and Percentage of Subjects With European League Against Rheumatism (EULAR) (CRP) Good Response at Weeks 12 and 24
Time Frame: 24 weeks

EULAR good response is defined as an improvement of >1.2 in DAS28 (CRP) relative to baseline.

This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non responders.
24 weeks
Number and Percentage of Subjects in Remission Using DAS28 (ESR) at Weeks 12 and 24
Time Frame: 24 weeks

DAS28(ESR) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.70 × ln[ESR]) +(0.014 × VASPA)

Remission = DAS28(ESR) < 2.6

This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non responders.
24 weeks
Number and Percentage of Subjects in Remission Using SDAI at Weeks 12 and 24
Time Frame: 24 weeks

SDAI = TJC28 + SJC28 + VASPA + VASPHA + CRP (mg/dL)

Remission: SDAI ≤ 3.3

This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non responders.
24 weeks
Number and Percentage of Subjects in Remission Using CDAI at Weeks 12 and 24
Time Frame: 24 weeks

CDAI = TJC28 + SJC28 + VASPA + VASPHA

Remission: CDAI ≤ 2.8

This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non responders.
24 weeks
Number and Percentage of Subjects in Remission Using Boolean Defined Remission Criteria at Weeks 12 and 24
Time Frame: 24 weeks

Boolean remission: tender joint count (TJC)28 ≤ 1 and swollen joint count (SJC)28 ≤ 1 and VASPA (cm) ≤ 1 and CRP (mg/dL) ≤ 1

This endpoint was analyzed using non-responder imputation (NRI), i.e., subjects with missing response at the concerned visit were treated as non responders.
24 weeks
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Weeks 12 and 24
Time Frame: from baseline till Week 24

The HAQ-DI is a 20-question instrument which assesses the degree of difficulty the subject had in accomplishing tasks in 8 functional areas over the previous week. The 8 areas are: dressing and grooming, hygiene, arising, reach, eating, grip, walking, common daily activities. Within each area, subjects report the amount of difficulty they have in performing the specific items. There are 4 response options ranging from: 0 = No Difficulty, 1 = With Some Difficulty, 2 = With Much Difficulty, 3 = Unable to Do. The 8 areas are each given a single score equal to the maximum value of their component activities (0, 1, 2, or 3). The sum of the area scores is then divided by the number of areas answered to obtain the final HAQ score (rounded to the nearest value evenly divisible by 0.125). The final HAQ-DI score ranges from 0 to 3. A high score means a high degree of disability (=worse outcome).

Missing values were imputed with the last non-missing observation.
from baseline till Week 24
Change From Baseline in Physical Component Score of Short Form Health Survey (SF-36) at Weeks 12 and 24
Time Frame: from baseline till Week 24
The Short Form (36) Health Survey (SF-36) consists of 36 items that can be summarized into 8 domains: physical functioning, role limitations due to physical health problems (role-physical), bodily pain, general health, vitality, social functioning, role limitations due to emotional problems (role-emotional), and mental health. Two summary measures, the physical component summary and the mental component summary, can be derived based on these domain scores. Each score is directly transformed into a 0-100 score on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.
from baseline till Week 24
Change From Baseline in Mental Component Score of Short Form Health Survey (SF-36) at Weeks 12 and 24
Time Frame: from baseline till Week 24
The Short Form (36) Health Survey (SF-36) consists of 36 items that can be summarized into 8 domains: physical functioning, role limitations due to physical health problems (role-physical), bodily pain, general health, vitality, social functioning, role limitations due to emotional problems (role-emotional), and mental health. Two summary measures, the physical component summary and the mental component summary, can be derived based on these domain scores. Each score is directly transformed into a 0-100 score on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.
from baseline till Week 24
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Subscale at Weeks 12 and 24
Time Frame: from baseline till Week 24
The FACIT Measurement System is a collection of health-related quality of life questionnaires that assess multidimensional health status in people with various chronic illnesses. The FACIT Fatigue Scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued). To score the FACIT-fatigue, all items are summed to create a single fatigue score with a range from 0 to 52. Items are reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue.
from baseline till Week 24
Pharmacokinetics: ALX-0061 Concentration in Serum at Weeks 12 and 24
Time Frame: at Week 12 and Week 24 visits
ALX-0061 concentrations were only measured in samples of subjects randomized to any of the ALX-0061 treatment arms. Samples were taken predose at the concerned visits.
at Week 12 and Week 24 visits
Pharmacodynamics: Concentrations of Soluble Interleukin-6 Receptor (sIL-6R) at Weeks 12 and 24
Time Frame: from baseline till Week 24
Values below the limit of quantification are imputed with the lower limit of quantification (LLOQ).
from baseline till Week 24
Number of Subjects With Development of a Treatment-emergent Antidrug Antibody Response
Time Frame: from baseline till follow-up (FU) (i.e., 12 weeks after last study drug dosing at Week 22 or after early treatment discontinuation)
from baseline till follow-up (FU) (i.e., 12 weeks after last study drug dosing at Week 22 or after early treatment discontinuation)
Number and Percentage of Subjects With Treatment-emergent Adverse Events by Severity
Time Frame: From first study drug intake until the Week 24 or Early Termination visit. Only safety data through Week 24 is reported as 256 of the 293 subjects who completed the 24-week treatment period rolled-over to the C203 Study and did not perform the FU visit
From first study drug intake until the Week 24 or Early Termination visit. Only safety data through Week 24 is reported as 256 of the 293 subjects who completed the 24-week treatment period rolled-over to the C203 Study and did not perform the FU visit
Number of Treatment-emergent Adverse Events by Severity
Time Frame: From first study drug intake until the Week 24 or Early Termination visit. Only safety data through Week 24 is reported as 256 of the 293 subjects who completed the 24-week treatment period rolled-over to the C203 Study and did not perform the FU visit
From first study drug intake until the Week 24 or Early Termination visit. Only safety data through Week 24 is reported as 256 of the 293 subjects who completed the 24-week treatment period rolled-over to the C203 Study and did not perform the FU visit
Number and Percentage of Subjects With Treatment-related Treatment-emergent Adverse Events
Time Frame: From first study drug intake until the Week 24 or Early Termination visit. Only safety data through Week 24 is reported as 256 of the 293 subjects who completed the 24-week treatment period rolled-over to the C203 Study and did not perform the FU visit
From first study drug intake until the Week 24 or Early Termination visit. Only safety data through Week 24 is reported as 256 of the 293 subjects who completed the 24-week treatment period rolled-over to the C203 Study and did not perform the FU visit
Number of Treatment-related Treatment-emergent Adverse Events
Time Frame: From first study drug intake until the Week 24 or Early Termination visit. Only safety data through Week 24 is reported as 256 of the 293 subjects who completed the 24-week treatment period rolled-over to the C203 Study and did not perform the FU visit
From first study drug intake until the Week 24 or Early Termination visit. Only safety data through Week 24 is reported as 256 of the 293 subjects who completed the 24-week treatment period rolled-over to the C203 Study and did not perform the FU visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ablynx

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 27, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2014

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ALX0061-C201
  • 2014-003033-26 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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