Trial Outcomes & Findings for Study of KB003 In Biologics-Inadequate Rheumatoid Arthritis (NCT NCT00995449)

Last Updated: 2014-06-09

Results Overview

KB003 was administered by intravenous (IV) infusion as a 600 mg dose at weeks 0, 2, 4, 8, and 12, with primary safety being evaluated at week 14 and a follow-up (end of study) safety assessment at week 30. Safety was evaluated by number of participants with treatment-emergent (TE) adverse events (AEs). (TE is defined as ocurring during the 14 week treatment and week 30 follow-up periods)

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

9 participants

Primary outcome timeframe

Weeks 14 & 30

Results posted on

2014-06-09

Participant Flow

This was a two-part study with a safety run-in. The primary objective of the main portion of the study was to evaluate the safety, PK, and efficacy of selected repeat-dose regimens of KB003 in subjects with active moderate to severe rheumatoid arthritis who had an inadequate treatment outcome from prior biologic therapy.

The safety run-in portion was conducted in a small cohort of 7 active and 2 placebo subjects to evaluate the acceptability of repeat-dose safety. KB003 was administered by intravenous (IV) infusion as a 600 mg dose at wks 0, 2, 4, 8, and 12, with primary safety being evaluated at wk 14 and a follow-up (end of study) safety assessment at wk 30.

Participant milestones

Participant milestones
Measure	KB003 600 mg 600 mg, KB003 a monoclonal antibody	Placebo Placebo comparator
Overall Study STARTED	7	2
Overall Study COMPLETED	5	2
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of KB003 In Biologics-Inadequate Rheumatoid Arthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	KB003 70mg Dose group not evaluated in this portion of study	KB003 200 mg Dose group not evaluated in this portion of study	KB003 600 mg n=7 Participants 600 mg, KB003 a monoclonal antibody	Placebo n=2 Participants Placebo comparator	Total n=9 Participants Total of all reporting groups
Age, Categorical <=18 years	—	—	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants
Age, Categorical Between 18 and 65 years	—	—	5 participants n=5 Participants	2 participants n=4 Participants	7 participants n=21 Participants
Age, Categorical >=65 years	—	—	2 participants n=5 Participants	0 participants n=4 Participants	2 participants n=21 Participants
Gender Female	—	—	4 participants n=5 Participants	1 participants n=4 Participants	5 participants n=21 Participants
Gender Male	—	—	3 participants n=5 Participants	1 participants n=4 Participants	4 participants n=21 Participants
Region of Enrollment United States	—	—	7 participants n=5 Participants	2 participants n=4 Participants	9 participants n=21 Participants

PRIMARY outcome

Timeframe: Weeks 14 & 30

Population: This safety run-in portion of the study was conducted in a small cohort of 7 active (600 mg) and 2 placebo subjects.

Outcome measures

Outcome measures
Measure	KB003 600 mg n=7 Participants 600 mg, KB003 a monoclonal antibody	Placebo n=2 Participants Placebo comparator
This Study Was Initiated With a Safety run-in Period to Evaluate Acceptability of Repeat-dose Safety.	7 Participants	2 Participants

Adverse Events

KB003 70mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

KB003 200 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

KB003 600 mg

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	KB003 70mg Dose group not evaluated in this portion of study	KB003 200 mg Dose group not evaluated in this portion of study	KB003 600 mg n=7 participants at risk 600 mg, KB003 a monoclonal antibody	Placebo n=2 participants at risk Placebo comparator
Gastrointestinal disorders Abdominal Hernia Obstructive	— 0/0 • Primary safety data was collected at week 14 and a follow-up(end of study) safety assessment at week 30.	— 0/0 • Primary safety data was collected at week 14 and a follow-up(end of study) safety assessment at week 30.	14.3% 1/7 • Number of events 1 • Primary safety data was collected at week 14 and a follow-up(end of study) safety assessment at week 30.	— 0/0 • Primary safety data was collected at week 14 and a follow-up(end of study) safety assessment at week 30.

Other adverse events

Other adverse events
Measure	KB003 70mg Dose group not evaluated in this portion of study	KB003 200 mg Dose group not evaluated in this portion of study	KB003 600 mg n=7 participants at risk 600 mg, KB003 a monoclonal antibody	Placebo n=2 participants at risk Placebo comparator
Gastrointestinal disorders Gastrointestinal Disorder	— 0/0 • Primary safety data was collected at week 14 and a follow-up(end of study) safety assessment at week 30.	— 0/0 • Primary safety data was collected at week 14 and a follow-up(end of study) safety assessment at week 30.	28.6% 2/7 • Number of events 4 • Primary safety data was collected at week 14 and a follow-up(end of study) safety assessment at week 30.	0.00% 0/2 • Primary safety data was collected at week 14 and a follow-up(end of study) safety assessment at week 30.
Infections and infestations Infections and Infestations	— 0/0 • Primary safety data was collected at week 14 and a follow-up(end of study) safety assessment at week 30.	— 0/0 • Primary safety data was collected at week 14 and a follow-up(end of study) safety assessment at week 30.	42.9% 3/7 • Number of events 4 • Primary safety data was collected at week 14 and a follow-up(end of study) safety assessment at week 30.	50.0% 1/2 • Number of events 1 • Primary safety data was collected at week 14 and a follow-up(end of study) safety assessment at week 30.
Musculoskeletal and connective tissue disorders Muscoskeletal and Connective Tissue Disorders	— 0/0 • Primary safety data was collected at week 14 and a follow-up(end of study) safety assessment at week 30.	— 0/0 • Primary safety data was collected at week 14 and a follow-up(end of study) safety assessment at week 30.	28.6% 2/7 • Number of events 2 • Primary safety data was collected at week 14 and a follow-up(end of study) safety assessment at week 30.	0.00% 0/2 • Primary safety data was collected at week 14 and a follow-up(end of study) safety assessment at week 30.
Nervous system disorders Nervous System Disorders	— 0/0 • Primary safety data was collected at week 14 and a follow-up(end of study) safety assessment at week 30.	— 0/0 • Primary safety data was collected at week 14 and a follow-up(end of study) safety assessment at week 30.	28.6% 2/7 • Number of events 2 • Primary safety data was collected at week 14 and a follow-up(end of study) safety assessment at week 30.	0.00% 0/2 • Primary safety data was collected at week 14 and a follow-up(end of study) safety assessment at week 30.
Psychiatric disorders Psychiatric Disorders	— 0/0 • Primary safety data was collected at week 14 and a follow-up(end of study) safety assessment at week 30.	— 0/0 • Primary safety data was collected at week 14 and a follow-up(end of study) safety assessment at week 30.	14.3% 1/7 • Number of events 2 • Primary safety data was collected at week 14 and a follow-up(end of study) safety assessment at week 30.	50.0% 1/2 • Number of events 1 • Primary safety data was collected at week 14 and a follow-up(end of study) safety assessment at week 30.
Cardiac disorders Cardiac Disorders	— 0/0 • Primary safety data was collected at week 14 and a follow-up(end of study) safety assessment at week 30.	— 0/0 • Primary safety data was collected at week 14 and a follow-up(end of study) safety assessment at week 30.	14.3% 1/7 • Number of events 1 • Primary safety data was collected at week 14 and a follow-up(end of study) safety assessment at week 30.	0.00% 0/2 • Primary safety data was collected at week 14 and a follow-up(end of study) safety assessment at week 30.
Injury, poisoning and procedural complications Injury, Poisoning and Procedural Complications	— 0/0 • Primary safety data was collected at week 14 and a follow-up(end of study) safety assessment at week 30.	— 0/0 • Primary safety data was collected at week 14 and a follow-up(end of study) safety assessment at week 30.	0.00% 0/7 • Primary safety data was collected at week 14 and a follow-up(end of study) safety assessment at week 30.	50.0% 1/2 • Number of events 1 • Primary safety data was collected at week 14 and a follow-up(end of study) safety assessment at week 30.
Vascular disorders Vascular Disorders	— 0/0 • Primary safety data was collected at week 14 and a follow-up(end of study) safety assessment at week 30.	— 0/0 • Primary safety data was collected at week 14 and a follow-up(end of study) safety assessment at week 30.	14.3% 1/7 • Number of events 1 • Primary safety data was collected at week 14 and a follow-up(end of study) safety assessment at week 30.	0.00% 0/2 • Primary safety data was collected at week 14 and a follow-up(end of study) safety assessment at week 30.

Additional Information

Nestor A. Molfino, MD., MSc

KaloBios Pharmaceuticals, Inc.

Phone: 650-243-3103

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The sponsor has right of first publication of trial results, which will be a joint, multi-center publication of the study results from all appropriate sites contributing data, analysis and comments.
Publication restrictions are in place

Restriction type: OTHER